EMVision Medical Devices (EMV) Q4 2024 TU earnings summary

Executive summary

• Interim Stage 2 clinical trial analysis confirmed hyperacute and acute ischaemic stroke detection capabilities, with the emu™ AI outperforming standard CT in some early cases.

• Stage 3 pre-validation clinical trial recruitment target achieved, supporting further AI algorithm development for stroke diagnosis.

• FDA pre-submission package delivered and under review, a key step toward validation trial and US market entry.

• Pilot commercial production line for the emu™ brain scanner established, enabling final $1.25M MMI grant payment.

• First Responder (Gen 2) proof-of-concept device fabricated, with studies to commence soon.

Financial highlights

• Cash reserves of $18.66 million at 30 June 2024.

• Net operating cash outflows for the quarter were $2.58 million, mainly due to increased R&D and staff costs.

• Interest income of $0.18 million and $1.25 million received from the MMI grant during the quarter.

• R&D expenditure increased to $1.896 million in Q4 FY24, up from $0.797 million in Q3 FY24.

• Estimated 7.2 quarters of funding available at current cash burn rate.

Outlook and guidance

• Stage 3 clinical trial data analysis and results expected in H2 CY2024.

• Validation clinical trial preparations underway, including protocol finalization and US site engagement.

• Further non-dilutive funding anticipated from FY24 R&D Tax Incentive and Australian Stroke Alliance grants.

• Road and air environment clinical studies for First Responder device targeted for later in 2024.