Going Concern Doubts Shadow Anteris’ DurAVR Trial Preparations

Financial Performance and Capital Raise

Anteris Technologies Global Corp. (ASX – AVR, NASDAQ – AVR) disclosed its financial results for the quarter and half-year ended June 30, 2025, filing its Form 10-Q with the U.S. Securities and Exchange Commission. The company reported a net loss attributable to shareholders of $42.7 million for the six-month period, a 22% increase compared to the prior year. Revenues declined 16% to $1.17 million, primarily reflecting the expiration of a key distribution agreement with LeMaitre Vascular in January 2025.

Despite the widening losses, Anteris bolstered its balance sheet with net proceeds of $80 million from its December 2024 initial public offering (IPO), which priced at $6.00 per share. These funds have been strategically allocated to accelerate the development of its lead product, the DurAVR Transcatheter Heart Valve (THV), and to prepare for the upcoming PARADIGM pivotal clinical trial.

Advancing DurAVR THV and Clinical Trial Preparations

The DurAVR THV system, a single-piece biomimetic heart valve designed to mimic natural aortic valve function, remains the centerpiece of Anteris’ innovation pipeline. The company has invested $37.6 million of IPO proceeds into ongoing R&D and clinical trial readiness. Notably, Anteris has qualified 79 clinical trial sites across the U.S., Europe, and Canada for the PARADIGM Trial, a randomized, controlled study intended to demonstrate non-inferiority against established transcatheter aortic valve replacement systems.

Regulatory engagement with the FDA continues, with the company submitting an investigational device exemption (IDE) application and targeting trial enrollment to commence in the third quarter of 2025. Parallel efforts are underway to secure CE Mark approval in Europe, positioning the DurAVR THV for eventual commercialization in major markets.

Operational and Manufacturing Scale-Up

In anticipation of the PARADIGM Trial, Anteris has significantly expanded its manufacturing capacity, tripling output capabilities through new ISO-qualified clean room facilities. The company is also diversifying its supply chain by sourcing its proprietary ADAPT tissue from both the U.S. and Australia to mitigate risks. These operational investments contributed to a 36% increase in R&D expenses to $32.8 million for the half-year, reflecting higher costs in manufacturing scale-up, clinical trial preparations, and headcount growth.

Governance and Financial Controls

While the company is progressing on multiple fronts, it disclosed ongoing material weaknesses in its internal controls over financial reporting, identified during audits of its 2024 and 2023 financial statements. Remediation efforts are underway but not yet complete, posing potential risks to the accuracy and timeliness of financial disclosures. Additionally, Anteris reiterated substantial doubt about its ability to continue as a going concern without securing additional capital, given its recurring losses and cash burn.

Looking Ahead

With a strengthened capital base from its recent IPO, Anteris is focused on navigating regulatory milestones and executing the PARADIGM Trial. Success in these areas will be critical to unlocking commercial opportunities for the DurAVR THV system and improving the company’s financial trajectory. However, investors should remain mindful of the inherent risks in clinical development, regulatory approval, and the need for further financing.