Anteris Technologies Announces Results for the Third Quarter of 2026

Quarterly operating cash outflows totaled $22.9 million as Anteris expanded trial activity and manufacturing capabilities.

Rhea-AI Summary

Anteris Technologies (AVR) reported third-quarter 2026 financial results and continued enrollment in its pivotal PARADIGM heart-valve trial across multiple countries. Net operating cash outflows were $22.9 million for the three months ended September 30, primarily supporting clinical, regulatory and manufacturing requirements for the trial. Research and development expenses were $21.3 million, reflecting manufacturing and quality expansion and trial activities, partly offset by lower product research costs.

Trial sites were enrolling in the United States, Canada, Denmark, the Netherlands and France. After quarter-end, Germany granted regulatory clearance, while Australia granted ethics approval and clinical-trial authorization. Anteris occupied its Northcross facility on September 1, adding production capacity ahead of commercialization. Brent Moen became chief financial officer effective September 11.

4 points · 0 major

MixediHow this balance works

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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.

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0 major · 2 points

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Positive

• Moderate pointPARADIGM enrollment progressed across active sites in five countries, with increased U.S. site activation.
• Minor pointPARADIGM received German regulatory clearance after quarter-end, supporting expansion into Germany.
• Minor pointAustralian trial expansion received HREC approval and TGA authorization under the Clinical Trial Notification pathway.
• Minor pointNorthcross facility occupancy on September 1 added production capacity for DurAVR valves and ComASUR delivery systems.

Negative

• Moderate pointNet operating cash outflows of $22.9 million primarily funded PARADIGM-related requirements in the third quarter.
• Minor pointResearch and development expenses of $21.3 million reflected manufacturing expansion and trial activities in the third quarter.

News Explained

At September 30, 2026, Anteris had $216,987,000 in cash and equivalents; measured against its Q3 operating cash outflow of $22,896,000, that balance equals 871.9 days of the last reported operating cash use—a backward-looking comparison, not a forward cash runway.

Sources and calculations

• Anteris Technologies Q3 2026 results release (2026-11-10)
• Anteris Q3 2026 fundamentals (2026Q3)

• Available liquidity against the last reported quarterly operating outflow, in days at that rate $216,987,000 / ($22,896,000 / 92) = 871.9 days

Key Figures

Net operating cash outflows: $22.9 million R&D expenses: $21.3 million

Net operating cash outflows

$22.9 million

Three months ended September 30, 2026

R&D expenses

$21.3 million

Quarter ended September 30, 2026

Previous Earnings Reports

1 past event · Latest: Aug 11

Same Type 1 event

1. Aug 11

   earnings report

   24h Move

   -3.3%

   Q2 2026 report disclosed $20.8 million cash outflows and $23.4 million R&D expenses.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

randomized controlled trial, non-inferiority, transcatheter heart valve, aortic stenosis

4 terms

randomized controlled trial medical

"a prospective randomized controlled trial which will evaluate the safety and effectiveness"

A randomized controlled trial is a research method that tests the effects of a new idea or treatment by randomly dividing participants into two groups: one that receives the treatment and one that does not. This approach helps ensure that the results are fair and unbiased, providing clear evidence about whether the treatment actually works. Investors value such trials because they offer reliable information that can influence decision-making and reduce uncertainty.

non-inferiority medical

"The PARADIGM Trial will assess non-inferiority on a primary composite endpoint"

A non-inferiority trial is a type of clinical test designed to show a new treatment is not meaningfully worse than an existing standard by more than a pre-set, acceptable amount. Think of it like proving a new smartphone model has battery life close enough to the leading model while offering other advantages; for investors, a successful non-inferiority result can clear the way to regulatory approval and market uptake even when the new option isn’t superior in headline effectiveness.

transcatheter heart valve medical

"DurAVR Transcatheter Heart Valve (“THV”) compared to commercially available"

A transcatheter heart valve is a replacement heart valve that is delivered through a blood vessel on a thin tube and expanded into place, allowing doctors to fix a damaged valve without opening the chest. It matters to investors because these devices can rapidly shift how a common condition is treated, driving sales or losses depending on regulatory approval, hospital adoption and insurance coverage—think of it like a less‑invasive product upgrade that needs widespread acceptance to pay off.

aortic stenosis medical

"to treat aortic stenosis – a potentially life-threatening condition"

Aortic stenosis is a narrowing of the heart’s aortic valve that makes it harder for blood to leave the heart, similar to a door that won’t open fully or a garden hose with a pinched end. It matters to investors because the condition drives demand for diagnostic tests, medicines, surgical procedures and medical devices; changes in treatment options, clinical trial results or regulatory approvals can quickly affect the revenue and valuation of companies in the healthcare and medical-device sectors.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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MINNEAPOLIS and BRISBANE, Australia, Nov. 10, 2026 (GLOBE NEWSWIRE) -- 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 September 30, 2026, and provided a corporate update.

Q3 2026 Highlights

• Continued execution of the PARADIGM Trial, with enrollment progressing across active sites in the U.S., Canada, Denmark, the Netherlands and France. Subsequent to quarter-end, the trial received regulatory clearance from Germany’s Federal Institute for Drugs and Medical Devices (BfArM) and advanced in Australia following HREC approval and TGA authorization under the Clinical Trial Notification pathway.
• Assumed occupancy of the Northcross facility in Minnesota, providing additional capacity to scale production of the DurAVR^® THVs and ComASUR^® Delivery System, in preparation for commercialization.
• Appointed Brent Moen as Chief Financial Officer, effective September 11, to support the Company’s financial and governance priorities as it advances the DurAVR THV toward commercialization.
  

“Q3 saw continued progress on multiple fronts. The PARADIGM Trial recruitment is advancing along with capacity expansion in line with our clinical and commercial plan. The Company also brought in some key hires to strengthen our operating model and future capabilities,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris.

Business & Operations

During the quarter, the Company continued to execute the global pivotal PARADIGM Trial across active sites in the United States, Canada and Europe.

The Company increased site activation in the United States and expanded the PARADIGM Trial into Canada and France, where sites are active and enrolling, following completion of key start-up activities, including site qualification, investigator training and operational readiness. Subsequent to quarter end, the trial received regulatory clearance from the German Federal Institute for Drugs and Medical Devices (BfArM), supporting its expansion into Germany. In Australia, the trial received Human Research Ethics Committee (HREC) approval and authorization from the Therapeutic Goods Administration (TGA) under the Clinical Trial Notification (CTN) pathway, further extending the trial’s geographic reach.

On September 1, the Company assumed occupancy as the primary tenant of the Northcross facility in Brooklyn Park, Minnesota. The facility provides additional capacity to scale production of the DurAVR THVs, the ComASUR Delivery System and related components in preparation for commercialization. The ComASUR Delivery System is designed to support controlled deployment and accurate placement of the balloon-expandable DurAVR THV, a new class of biomimetic transcatheter aortic valve.

Financial Results

The financial results for Anteris for the quarter ended September 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 September 30, 2026, were $22.9 million, primarily attributable to clinical, regulatory and manufacturing requirements to support the ongoing 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 $21.3 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 September 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.

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.

DurAVR THV is intended for INVESTIGATIONAL USE ONLY. Not available for commercial use or sale worldwide. CAUTION—Investigational device. Limited by Federal (or United States) law to investigational use.

Forward-Looking Statements

This announcement contains forward-looking statements, including, but not limited to, statements regarding the PARADIGM Trial, 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.

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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What were Anteris Technologies' operating cash outflows and R&D expenses for Q3 2026?

Anteris recorded $22.9 million in net operating cash outflows and $21.3 million in research and development expenses for the three months ended September 30, 2026. Operating cash outflows primarily supported clinical, regulatory and manufacturing requirements for the ongoing PARADIGM Trial.

What will Anteris Technologies' PARADIGM Trial measure?

PARADIGM will evaluate whether DurAVR is not inferior to commercially available replacement valves on a combined measure of all-cause mortality, all stroke and cardiovascular hospitalization at one year after the procedure. The randomized study will enroll approximately 1,000 patients in its All Comers Randomized Cohort, assigned 1:1 to DurAVR or commercially available, approved transcatheter heart valves.