Half Yearly Report and Accounts

• Revenue from continuing operations up 5% to $1.7 million
• Loss from continuing activities after tax up 42% to $4.7 million
• Secured FDA De Novo clearance for PainChek Adult App in US, unlocking $175 million annual market

During the half-year, PainChek Limited reported a loss from operations of $4,701,714, a 42% increase compared to the prior corresponding period. This was principally due to increased costs, including cost of sales ($1,233,711), research and development expenditure ($1,643,401), marketing and business development expenses ($1,738,964), and corporate and administration expenses ($1,683,339). The company also did not receive an R&D grant in the current period, compared to $1,373,885 in the prior corresponding period. On the operational front, PainChek made significant progress, particularly in the US market. The company secured FDA De Novo clearance for its Adult App in October 2025, becoming the first and only regulated medical device enabling pain assessment for people with moderate to severe dementia in US long-term care settings. This provides initial access to an estimated AUD $175 million annual long-term care market, with broader opportunities in home care and hospital sectors via future 510(k) pathways. PainChek also continued to scale its global footprint, with implemented licenses growing 12% to an ARR of $3.7 million and 75,590 paying implementations by 31 December 2025. Customer retention remained strong, with 85% renewal rates in core markets and 59% of customers contracted for 3+ years.The company made progress on its PainChek Infant consumer app, with the app publicly available in Australia and early phase commercial developments underway, including a revised subscription pricing model and content partnerships. PainChek also continued to invest in strategic R&D and integration initiatives across markets.

The company expects to obtain a Research & Development Tax incentive refund by 31 May 2026 for the year to 30 June 2025.

PainChek will continue to focus on driving adoption of its Adult App in the US market, leveraging the FDA clearance and reimbursement opportunities. The company will also progress development and commercialization of its Infant and future Toddler App products.