Anteris Announces Results for the Second Quarter of 2025
Anteris Technologies (NASDAQ: AVR) has reported its Q2 2025 financial results and corporate updates, highlighting significant progress in its DurAVR庐 THV (transcatheter heart valve) program. The company has successfully treated 130 patients with DurAVR庐 since clinical development began, including 21 patients in Q2 2025.
Key developments include the world's first "double DurAVR庐" implant for both mitral and aortic valve positions, and advancement of the global PARADIGM Trial with 79 qualified clinical sites. The company appointed Dr. Michael J. Reardon and Professor Stephan Windecker as Trial Co-Chairs and added two new board members. Financial results show net operating cash outflows of $41.0 million for H1 2025, with $28.4 million in cash as of June 30, 2025.
Anteris Technologies (NASDAQ: AVR) ha comunicato i risultati finanziari del secondo trimestre 2025 e aggiornamenti aziendali, mettendo in evidenza notevoli progressi nel programma DurAVR庐 THV (valvola cardiaca transcatetere). L'azienda ha trattato con successo 130 pazienti con DurAVR庐 dall'inizio dello sviluppo clinico, di cui 21 pazienti nel 2T 2025.
I principali sviluppi includono il primo impianto al mondo "double DurAVR庐" per le sedi mitrale e aortica e l'avanzamento del Trial PARADIGM globale con 79 siti clinici qualificati. La societ脿 ha nominato il Dr. Michael J. Reardon e il Professor Stephan Windecker co-presidenti del Trial e ha aggiunto due nuovi membri al consiglio. I risultati finanziari mostrano uscite nette di cassa operative per 41,0 milioni di dollari nel primo semestre 2025, con 28,4 milioni di dollari in cassa al 30 giugno 2025.
Anteris Technologies (NASDAQ: AVR) ha informado sus resultados financieros del segundo trimestre de 2025 y actualizaciones corporativas, destacando avances importantes en su programa DurAVR庐 THV (v谩lvula card铆aca por cat茅ter). La compa帽铆a ha tratado con 茅xito a 130 pacientes con DurAVR庐 desde el inicio del desarrollo cl铆nico, incluidos 21 pacientes en el 2T 2025.
Los hitos clave incluyen el primer implante mundial "double DurAVR庐" para las posiciones mitral y a贸rtica, y el avance del ensayo global PARADIGM con 79 sitios cl铆nicos calificados. La compa帽铆a nombr贸 al Dr. Michael J. Reardon y al Profesor Stephan Windecker como copresidentes del ensayo y a帽adi贸 dos nuevos miembros a la junta. Los resultados financieros muestran salidas netas de efectivo operativas de $41.0 millones en el primer semestre de 2025, con $28.4 millones en efectivo al 30 de junio de 2025.
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欤检殧 靹标臣搿滊姅 鞀闺韺愱臣 雽�霃欕Д韺� 鞙勳箻鞐� 氇憪 鞝侅毄頃� 靹戈硠 斓滌磮鞚� "double DurAVR庐" 鞚挫嫕瓿� 79臧滌潣 鞝侁博 鞛勳儊 靷澊韸�毳� 頇曤炒頃� 旮�搿滊矊 PARADIGM 鞁滍棙鞚� 歆勳爠鞚� 韽暔霅╇媹雼�. 須岇偓電� Dr. Michael J. Reardon瓿� Professor Stephan Windecker毳� 鞁滍棙 瓿惦彊鞚橃灔鞙茧 鞛勲獏頃橁碃 鞚挫偓須岇棎 霊� 氇呾潣 鞁犼窚 鞚挫偓毳� 於旉皜頄堨姷雼堧嫟. 鞛 瓴瓣臣電� 2025雲� 靸侂皹旮� 靾� 鞓侅梾 順勱笀 鞙犾稖 $41.0 million鞚� 旮半頄堨溂氅�, 2025雲� 6鞗� 30鞚� 旮办 $28.4 million鞚� 順勱笀鞚� 氤挫湢頃橁碃 鞛堨姷雼堧嫟.
Anteris Technologies (NASDAQ: AVR) a publi茅 ses r茅sultats financiers du deuxi猫me trimestre 2025 et des mises 脿 jour d'entreprise, mettant en avant des progr猫s significatifs dans son programme DurAVR庐 THV (valve cardiaque par voie percutan茅e). La soci茅t茅 a trait茅 avec succ猫s 130 patients avec DurAVR庐 depuis le d茅but du d茅veloppement clinique, dont 21 patients au T2 2025.
Parmi les avanc茅es cl茅s figurent la premi猫re implantation mondiale "double DurAVR庐" pour les positions mitrale et aortique, et la progression de l'essai PARADIGM 脿 l'茅chelle mondiale avec 79 sites cliniques qualifi茅s. La soci茅t茅 a nomm茅 le Dr Michael J. Reardon et le Professeur Stephan Windecker co-pr茅sidents de l'essai et a ajout茅 deux nouveaux administrateurs au conseil. Les r茅sultats financiers indiquent des sorties nettes de tr茅sorerie d'exploitation de 41,0 M$ pour le 1er semestre 2025, avec 28,4 M$ en tr茅sorerie au 30 juin 2025.
Anteris Technologies (NASDAQ: AVR) hat seine Finanzergebnisse f眉r das 2. Quartal 2025 sowie Unternehmensupdates ver枚ffentlicht und dabei bedeutende Fortschritte im DurAVR庐 THV-Programm (transkatheter Herzklappe) hervorgehoben. Das Unternehmen hat seit Beginn der klinischen Entwicklung erfolgreich 130 Patienten mit DurAVR庐 behandelt, darunter 21 Patienten im 2. Quartal 2025.
Zu den wichtigen Entwicklungen z盲hlen der weltweit erste "double DurAVR庐"-Eingriff f眉r die Mitral- und Aortenklappenposition sowie der Fortschritt der globalen PARADIGM-Studie mit 79 qualifizierten klinischen Zentren. Das Unternehmen ernannte Dr. Michael J. Reardon und Professor Stephan Windecker zu Co-Chairs der Studie und erg盲nzte den Vorstand um zwei neue Mitglieder. Die Finanzzahlen zeigen operative Netto-Cashabfl眉sse in H枚he von $41.0 Millionen f眉r das erste Halbjahr 2025, bei $28.4 Millionen an liquiden Mitteln zum 30. Juni 2025.
- Successfully treated 130 patients with DurAVR庐 THV, including 49 in H1 2025
- Achieved world-first double DurAVR庐 implant for both mitral and aortic valve positions
- Expanded clinical trial infrastructure with 79 qualified sites for PARADIGM Trial
- Strengthened leadership with appointment of prestigious PARADIGM Trial Co-Chairs
- Significant cash burn with $41.0 million in operating cash outflows for H1 2025
- High R&D expenses of $16.3 million in Q2 2025
- Declining cash position at $28.4 million as of June 30, 2025
Insights
Anteris making steady progress with DurAVR THV, advancing toward pivotal PARADIGM Trial while managing significant cash burn.
Anteris continues to build momentum with its DurAVR THV (Transcatheter Heart Valve) system, demonstrating consistent patient adoption with 21 new implants this quarter, bringing the total to 130 patients treated since development began. This steady cadence (49 patients year-to-date) indicates growing physician comfort with the technology and expanding clinical experience across diverse cases, including a noteworthy "double DurAVR" procedure in both mitral and aortic positions.
The company's primary focus remains the upcoming global PARADIGM Trial, with substantial infrastructure development including 79 qualified clinical sites across multiple countries. The appointment of high-profile co-chairs Dr. Michael Reardon and Professor Stephan Windecker brings valuable credibility and experience to the trial. The ongoing FDA engagement for Investigational Device Exemption approval represents the critical regulatory gating item before full trial initiation.
However, the financial picture reveals significant investment required to support these clinical and regulatory activities. Operating cash outflows reached $41 million for the first half of 2025, with R&D expenses of $16.3 million in Q2 alone. With $28.4 million cash remaining, the current burn rate raises questions about the company's runway beyond 2-3 quarters without additional financing. This is particularly relevant as the company scales manufacturing capabilities and moves toward the resource-intensive PARADIGM Trial.
The strategic board appointments of David Roberts and Gregory Moss strengthen operational leadership and corporate governance capabilities - important additions as Anteris transitions from early clinical work to pivotal trial execution and potential commercialization planning.
Anteris shows clinical progress but accelerating cash burn warrants careful monitoring of financing options and runway.
Anteris' financial position requires close attention as the company transitions to its pivotal trial phase. The $41 million operating cash outflow for H1 2025 represents significant investment in R&D ($16.3 million in Q2 alone) and preparation for the PARADIGM Trial. With $28.4 million cash remaining as of June 30, 2025, and quarterly expenses trending upward, the company likely has runway into early 2026 at current burn rates - potentially insufficient to fund the entirety of its pivotal trial.
The R&D spending increase aligns with necessary regulatory work, investigator engagement, and manufacturing scale-up activities typical of a medical device company entering a pivotal trial phase. The $5 million in SG&A expenses appears controlled, suggesting appropriate focus on clinical development rather than premature commercial infrastructure.
Anteris hasn't disclosed specific financing plans in this release, but additional capital will almost certainly be required before potential commercialization. The timing of any financing will be critical - ideally securing funds before cash levels become critically low, which would weaken negotiating position.
The strategic board appointments provide relevant expertise for this growth phase, with operational leadership (Roberts) and legal/governance (Moss) experience that complements existing directors. These additions suggest preparation for more complex corporate and potential partnership activities ahead.
Investors should watch closely for IDE approval milestones, as this regulatory green light would validate the company's approach and potentially create more favorable conditions for capital raising. The steady clinical adoption (21 patients this quarter) demonstrates continued physician interest, but the financial demands of a global pivotal trial will significantly increase cash needs in coming quarters.
MINNEAPOLIS and BRISBANE, Australia, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Anteris Technologies Global Corp. (Anteris or the Company) (NASDAQ: AVR, ASX: AVR) a global structural heart company committed to designing, developing, and commercialising cutting-edge medical devices to restore healthy heart function, today reported financial results for the quarter ended June 30, 2025, and provided a corporate update.
Second Quarter 2025 Highlights
- 130 patients implanted with the DurAVR庐 THV since the start of clinical development; 49 patients treated year-to-date; 21 in the quarter
- World first 鈥渄ouble DurAVR庐鈥� implant in a patient receiving a valve-in-valve replacement in both the mitral and aortic valve positions
- Advanced preparatory work for the DurAVR庐听THV's global, pivotal clinical trial (the "PARADIGM Trial") including qualifying additional clinical sites (79 sites now qualified)
- Held global investigator meeting for the PARADIGM Trial in June, with Dr. Michael J. Reardon and Professor Stephan Windecker being confirmed as Co-Chairs of the PARADIGM Trial
- Continued ongoing engagement with the FDA to progress the Investigational Device Exemption (鈥淚DE鈥�) for the PARADIGM Trial
- Appointed two Non-Executive Directors to the Board of Directors (Mr. David Roberts and Mr. Gregory Moss)
鈥淚鈥檓 extremely pleased with the progess achieved during the second quarter as the Company enters a new phase in its life cycle. The data generated to date from 130 patients treated with DurAVR庐 across multiple settings, including complex anatomies, different annular sizes, bicuspids and valve-in-valve (including a double aortic and mitral replacement in the same patient) is highly compelling. By adopting a 鈥渢otal disease management鈥� approach, the development of this first-in-class biomimetic transcatheter heart valve has delivered meaningful clinical benefits across a range of clinical use cases. As such, we are excited by physician enthusiasm across the globe to recruit into the PARADIGM study which is designed to further support the growing body of evidence demonstrating DurAVR庐听THV鈥檚 impact on patients,鈥� said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris.
Business & Operations
DurAVR庐 THV Commercialisation Update
Building our Clinical data 鈥� 130 patients successfully treated with the DurAVR庐 THV
Anteris has continued to expand the level of global experience and build the body of clinical evidence with the DurAVR庐 THV System. At the end of the Second Quarter, there were 130 patients successfully implanted with the DurAVR庐 THV in rolling cohorts since start of clinical development, with 49 of these patients treated in the first half of 2025 and 21 in 2Q 2025. These additional patients continue to support the strong clinical benefits of our new class of biomimetic TAVR over current commercially available TAVR platforms.
Activities supporting the launch of the PARADIGM Trial
Over the Second Quarter, the Anteris team made considerable progress strengthening its clinical infrastructure and manufacturing capabilities in preparation for the Trial. A key focus was the qualification of trial sites, including feasibility assessments to confirm each site鈥檚 access to a suitable aortic stenosis patient population and their capacity to conduct the Trial to the highest standards. Preparatory activities, including site contracting with planned centers across the U.S., Europe and Canada, are well advanced, with 79 sites now qualified to participate.
In May, Anteris hosted a European Investigator Meeting for the PARADIGM Trial to facilitate operational alignment of qualified sites across the European investigator network, with participation from principal investigators at leading sites in Denmark, France, Germany, the Netherlands and Switzerland.
In June, Anteris hosted a Global Investigator Meeting to formally initiate activities for the PARADIGM Trial ahead of anticipated regulatory clearance. Dr. Michael J. Reardon and Professor Stephan Windecker were confirmed as the Co-Chairs of the Trial during the meeting, held in conjunction with New York Valves. These physicians provide significant clinical and trial experience in interventional cardiology and TAVR.
Ongoing collaborative work with the U.S. Food and Drug Administration (FDA) to progress the Investigational Device Exemption (IDE) application has been a major focus this Quarter, in addition to proactively scaling the manufacturing of all key products to meet the anticipated inventory demands of the upcoming PARADIGM Trial.
Corporate matters - Board appointments
On 10 June, Anteris appointed two seasoned executives, David Roberts and Gregory Moss, to its Board of Directors. Mr. Roberts brings extensive operational leadership experience, and Mr. Moss offers expertise in legal and corporate governance. These appointments are strategic steps to bolster the Company's leadership as it advances its clinical and commercial objectives.
Second Quarter 2025 Financial Results
The financial results for Anteris for the quarter ended June 30, 2025 are reviewed below. All amounts in $ refer to US dollars.
The Company鈥檚 net operating cash outflows for the six months ended June 30, 2025 were
- R&D expenses were
$16.3 million .
The key activities undertaken were the preparatory activities linked to the PARADIGM Trial, including regulatory work regarding the IDE, extensive engagement with planned investigators at clinical trial sites and the Global Investigator Meeting. Additionally, there were clinical costs associated with the enrollment of additional DurAVR庐 patients and further upscaling of manufacturing capabilities.
- Selling, general and administrative expenses were
$5.0 million .
The Company held
Anteris refers to the detailed Financial Information contained in its Form 10-Q filing including the Management Discussion & Analysis and the Risks.
About Anteris
Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercialising 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鈥� lead product, the DurAVR庐 Transcatheter Heart Valve (THV), was designed in partnership with the world鈥檚 leading interventional cardiologists and cardiac surgeons to treat aortic stenosis 鈥� a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR庐 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庐 THV is made using a single piece of moulded ADAPT庐 tissue, Anteris鈥� patented anti-calcification tissue technology. ADAPT庐 tissue, which is FDA-cleared, has been used clinically for over 10聽years and distributed for use in over 55,000 patients worldwide. The DurAVR庐 THV System is comprised of the DurAVR庐 valve, the ADAPT庐 tissue, and the balloon-expandable ComASUR庐 Delivery System.
Forward-Looking Statements
This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts, including the objectives of and plans for Anteris鈥� studies and trials, the timing of the PARADIGM Trial, the goals of the expansion of the global manufacturing capacity and the sourcing of ADAPT庐 tissue for the DurAVR庐 THV in the future. Forward-looking statements generally are identified by the words 鈥渂elieve,鈥� 鈥減roject,鈥� 鈥渆xpect,鈥� 鈥渁nticipate,鈥� 鈥渆stimate,鈥� 鈥渋ntend,鈥� 鈥渂udget,鈥� 鈥渢arget,鈥� 鈥渁im,鈥� 鈥渟trategy,鈥� 鈥減lan,鈥� 鈥済uidance,鈥� 鈥渙utlook,鈥� 鈥渕ay,鈥� 鈥渟hould,鈥� 鈥渃ould,鈥� 鈥渨ill,鈥� 鈥渨ould,鈥� 鈥渨ill be,鈥� 鈥渨ill continue,鈥� 鈥渨ill likely result鈥� 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 鈥淩isk Factors鈥� in Anteris鈥� Annual Report on Form 10-K for the fiscal period ended December 31, 2024 that was filed with the SEC and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, neither ATL or Anteris assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations.
Authorization and Additional information
This announcement was authorized for release by the Board of Directors.
For more information:
| Investor Relations聽 [email protected] Debbie Ormsby Anteris Technologies Global Corp. +61 1300 550 310 | +61 7 3152 3200 | Investor Relations (US) [email protected] Malini Chatterjee, Ph.D. Blueprint Life Science Group +1 917 330 4269 |
| Website X | www.anteristech.com @AnterisTech https://www.linkedin.com/company/anteristech |
FAQ
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