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Anteris Announces Results for the First Quarter of 2026

(Moderate)
(Very Positive)
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Anteris (NASDAQ/ASX: AVR) reported Q1 2026 results and clinical progress. The company completed $320 million in capital raises in January 2026 to fund the PARADIGM pivotal trial and advance DurAVR® THV commercialization.

PARADIGM enrollment continued in Europe and began in the U.S., supported by a CMS TAVR coverage determination. Net operating cash outflows were $28.7 million, including $17.5 million in R&D expenses focused on manufacturing scale-up and trial-related activities. Anteris also presented new DurAVR® clinical data from the EMBARK and U.S. Early Feasibility studies at CRT 2026 and Sydney Valves 2026.

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Positive

  • $320 million capital raised in January 2026 for PARADIGM and commercialization
  • PARADIGM global pivotal trial enrollment active in Europe and United States
  • CMS TAVR NCD 20.32 coverage supports U.S. PARADIGM site adoption and recruitment
  • R&D spend $17.5m focused on manufacturing, quality scale-up and PARADIGM activities
  • DurAVR clinical data presented from EMBARK and U.S. Early Feasibility studies

Negative

  • Net operating cash outflow of $28.7m in Q1 2026
  • Elevated R&D and clinical costs linked to PARADIGM Trial activities

News Market Reaction – AVR

-2.54%
2 alerts
-2.54% Session close to close
-2.6% Trough Tracked
$634.93M Market Cap
0.0x Rel. Volume

In the May 13 session, AVR declined 2.54%, reflecting a moderate negative market reaction. Argus tracked a trough of -2.6% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement details Q1 2026 execution on the PARADIGM Trial and underscores Anteris’s investme...
Analysis

This announcement details Q1 2026 execution on the PARADIGM Trial and underscores Anteris’s investment phase, with net operating cash outflows of $28.7 million and R&D expenses of $17.5 million. It also reminds investors of the recently completed $320 million in capital raises that support this strategy. Historically, earnings have moved the stock by an average of -1.99%, so future quarters’ updates on trial progress and cash usage remain key metrics to monitor.

Key Figures

Capital raises: $320 million Net operating cash outflows: $28.7 million R&D expenses: $17.5 million
3 metrics
Capital raises $320 million Aggregate capital raises completed in January 2026
Net operating cash outflows $28.7 million Three months ended March 31, 2026
R&D expenses $17.5 million Quarter ended March 31, 2026

Previous Earnings Reports

5 past events · Latest: Feb 26 (Positive)
Same Type Pattern 5 events
Date Event Sentiment 24h Move Catalyst
Feb 26 2025 full-year results Positive +2.7% 2025 results with pivotal PARADIGM initiation and strong DurAVR clinical outcomes.
Nov 12 Q3 2025 results Negative -2.6% Q3 2025 update showing higher cash outflows while scaling PARADIGM and manufacturing.
Aug 11 Q2 2025 results Positive +6.0% Q2 2025 earnings highlighting DurAVR patient growth and PARADIGM site expansion.
May 13 Q1 2025 results Negative -9.9% Q1 2025 results with rising net loss and declining net sales despite trial progress.
Mar 12 2024 full-year results Negative -6.2% 2024 update combining U.S. IPO and trial prep with sizeable net loss and cash burn.

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

Pattern Detected

Earnings releases have consistently driven price moves that align with the overall tone of the updates, often skewing negative but with occasional strong positive reactions when clinical or strategic milestones are emphasized.

Recent Company History

Across prior earnings events from 2024–2025, Anteris used results updates to highlight DurAVR® THV progress, regulatory milestones, and pivotal PARADIGM Trial preparation. These included advancing from planning to global pivotal execution, scaling manufacturing, and disclosing cash burn and funding needs. Market reactions around these earnings ranged from sharp declines (e.g., Q1 2025) to solid gains when clinical traction and capital strength were foregrounded. Today’s Q1 2026 update continues that pattern, emphasizing PARADIGM recruitment and previously completed $320M capital raises.

Key Terms

centers for medicare and medicaid services (cms), national coverage determination, early feasibility study (efs)
3 terms
centers for medicare and medicaid services (cms) regulatory
"In the United States, recent coverage determination by the Centers for Medicare and Medicaid Services (CMS) is expected to facilitate patient recruitment..."
The Centers for Medicare & Medicaid Services (CMS) is a U.S. federal agency that runs the country’s major public health insurance programs and sets rules for how providers get paid and how medical products are covered. Investors care because CMS decisions on coverage, payment rates, and rules can change how much revenue healthcare companies earn—think of CMS like a giant client or regulator whose pricing and coverage choices can make or break a product’s market.
national coverage determination regulatory
"Eligible procedures... are covered under the Transcatheter Aortic Valve Replacement (TAVR) National Coverage Determination 20.32."
A national coverage determination is a federal decision that establishes whether a government health insurer will pay for a specific medical test, treatment, device, or service across the entire country. Think of it like a nationwide rule that tells doctors, hospitals and patients whether that category of care will be covered; for investors, such a decision can quickly expand or limit market access, reimbursement rates, and revenue potential for manufacturers and healthcare providers.
early feasibility study (efs) medical
"Presented clinical data from the ongoing EMBARK Study and U.S. Early Feasibility Study (EFS) at Cardiovascular Research Technologies..."
An early feasibility study (EFS) is a small, first-in-human trial that tests a new medical device or treatment to confirm it is safe and works as intended and to guide final design and study plans. For investors, an EFS is like a prototype test drive: positive results reduce technical and regulatory uncertainty, clarify development timelines and costs, and increase the odds of reaching larger, commercial trials that drive value.

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

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MINNEAPOLIS and BRISBANE, Australia, May 12, 2026 (GLOBE NEWSWIRE) -- 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 March 31, 2026, and provided a corporate update.

Q1 2026 Highlights

  • Completed aggregate capital raises totalling $320 million in January 2026 to support execution of the PARADIGM Trial and advance the Company toward global commercialization 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. enrollment 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 enrollment 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 enrollment 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 enrollment 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 enrollment momentum as additional sites come on line and contribute to trial execution.

Financial Results

The financial results for Anteris for the quarter ended March 31, 2026, are presented below. All amounts in $ refer to U.S. dollars.

The Company’s net operating cash outflows for the three months ended March 31, 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 enrollment 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.

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.

For more information:

Global Investor RelationsInvestor Relations (US)
investors@anteristech.com mchatterjee@bplifescience.com 
Debbie OrmsbyMalini Chatterjee, Ph.D.
Anteris Technologies Global Corp.Blueprint Life Science Group
+61 1300 550 310 | +61 7 3152 3200+1 917 330 4269


Websitewww.anteristech.com 
X@AnterisTech
LinkedInhttps://www.linkedin.com/company/anteristech 



FAQ

What were Anteris (AVR) key financial results for Q1 2026?

Anteris reported Q1 2026 net operating cash outflows of $28.7 million. According to Anteris, this primarily reflected clinical, regulatory and manufacturing spending to support the PARADIGM Trial, including $17.5 million in R&D expenses tied to manufacturing scale-up and trial-related activities.

How much capital did Anteris (AVR) raise in early 2026?

Anteris completed aggregate capital raises totaling $320 million in January 2026. According to Anteris, this funding is intended to support execution of the PARADIGM global pivotal trial and advance the company toward global commercialization of the DurAVR® transcatheter heart valve system.

What progress did Anteris (AVR) report on the PARADIGM Trial in Q1 2026?

Anteris reported ongoing PARADIGM Trial enrollment in Europe and newly started enrollment in the United States. According to Anteris, multiple centers are advancing through ethics and regulatory approvals, site initiation visits, investigator training, and active patient screening and enrollment as additional sites are activated.

How does the CMS TAVR coverage decision affect Anteris PARADIGM enrollment?

Anteris indicated that a recent CMS coverage determination should facilitate U.S. PARADIGM recruitment. According to Anteris, eligible procedures at participating U.S. study sites fall under TAVR National Coverage Determination 20.32, supporting reimbursement and potentially easing site-level adoption and patient enrollment.

What clinical data did Anteris (AVR) present on DurAVR in early 2026?

Anteris presented DurAVR® clinical data from the ongoing EMBARK Study and U.S. Early Feasibility Study. According to Anteris, these data were shared at CRT 2026 and Sydney Valves 2026, supporting continued scientific engagement and information exchange with the structural heart clinical community.

How were Anteris (AVR) R&D expenses allocated in Q1 2026?

Anteris recorded $17.5 million in R&D expenses in Q1 2026. According to Anteris, spending focused on upscaling manufacturing and quality capabilities, process design and validation, headcount expansion, and PARADIGM Trial activities, partly offset by reduced DurAVR® THV product research costs.