• Achieved 110,000 global contracted PainChek licences, up 16% year-over-year
• Made substantial progress towards FDA de Novo clearance for the Adult App in the US
• Established PainChek Corporation and core US team to prepare for anticipated FDA approval

PainChek Limited reported a net loss of $7.67 million for the year ended 30 June 2025, an 8% improvement over the prior year. The company continued to demonstrate strong growth momentum across its three core strategic pillars: US market entry, continued growth of the Adult App in ANZ, UK, and Canada, and the direct-to-parent market entry of the Infant App. In the US, PainChek made substantial progress towards securing FDA de Novo clearance for its Adult App, completing a comprehensive clinical validation study and holding a productive final meeting with the FDA. The company also established PainChek Corporation and appointed a Head of Business Development US to prepare for anticipated FDA approval and rapid commercial deployment. PainChek's established markets continued to show strong growth, with the company achieving 110,000 global contracted licences, up 16% year-over-year. Of these, 71,000 have been implemented, representing an annual recurring revenue of $3.6 million. The company also made significant progress towards operational break-even in its core ANZ and UK markets through cost optimization and improved customer retention.The company continued to invest in research and development, with third-party costs of $528,867 associated with the US FDA clinical study and submission. Share-based payments to directors and employees also decreased to $470,299 from $710,369 in the prior year.

PainChek expects to receive FDA de Novo clearance for its Adult App in the US, which represents the company's largest growth opportunity. The company has established key partnerships and operational frameworks to enable rapid commercial deployment upon regulatory approval.

PainChek is well-positioned to capitalize on its progress in the US market, as well as continued growth in its established markets. The company remains focused on achieving operational break-even in its core regions while investing in strategic initiatives to drive long-term sustainable growth.