SUMMARY

• No operational concerns - progress on both emu Bedside and emu First Responder is marching along nicely
• As external funding has mostly ended, EMV now only has about 4 quarters of funding available vs expectations of market entry for emu Bedside Scanner during CY2026
• Clearly feels insufficient, is a risk, and will need to be addressed soon - share price will remain subdued until this is clearly resolved.

Discl: Held IRL and in SM

Operational Highlights

1. Neurodiagnostic algorithms deliver excellent results in EMView study - previously reported in Nov 2024, so not new news
2. Validation (pivotal) trial preparations well progressed after positive FDA engagement, commencement of the validation (pivotal) trial fast approaching

• Trial of up to 300 suspected stroke patients is expected, with a primary endpoint of “Blood or not” sensitivity and specificity.
• 6 leading clinical sites - 4 in US, 2 in Australia, anticipated enrolment of 6-12 months
• Ethics approval being pursued in both the US and Australia
• Assuming successful trial, market entry is projected to be during CY2026

3. First Responder POC Brain Scanner 

• 2 additional First Responder devices have been fabricated - additional devices are targeted for deployment in a pre-hospital feasibility study scheduled to commence this quarter
• Healthy human volunteer study is underway
• Up to 30 participants are expected to be enrolled across aeromedical (RFDS) and road ambulance study arms

Financials

• 2QFY25 Net Operating cash outflows were $3.27m - largest quarterly outflow in the past 2.5 years - driven by R&D expenses ($1.18m) and the lack of funding inflows
• R&D costs increased in the current quarter due to the purchase of components for devices to be used in the upcoming validation trial
• Proforma cash reserves of $15.78m, including $2.12m FY24 R&D tax rebate received after quarter end
• EMV’s activities over the remainder of FY25 will be supported by further non-dilutive funding from the ASA grant program - $0.8m expected
• EMV continues to actively pursue non-dilutive funding opportunities to advance and accelerate other activities, including the First Responder device.