HeartSciences (HSCS) Q2 2025 earnings summary

Executive summary

• Focused on AI-based ECG technology, advancing device hardware and cloud-native software to expand ECG's clinical utility for cardiac dysfunction detection and broader heart disease screening via proprietary MyoVista wavECG device and cloud platform.

• MyoVista wavECG is on track for FDA 510(k) submission by end of Q1 2025, with cloud platform/algorithms targeting regulatory clearance in H2 2025.

• MyoVista wavECG and related AI-ECG algorithms included in CMS 2025 OPPS final rule, enabling reimbursement from January 2025.

• Recent developments include a corporate name change, Nasdaq compliance via reverse stock split, new patents in India and the US, and a new corporate website launch.

• Demonstrated MyoVista wavECG at the UN General Assembly Digital Health Symposium, highlighting its transformative potential.

Financial highlights

• No revenue recognized for Q2 FY2025 or the six months ended October 31, 2024; prior year revenue was $4,000.

• Net loss of $2.1 million for the quarter and $4.1 million for the six months ended October 31, 2024, compared to $1.7 million and $3.1 million in the prior year.

• Cash and cash equivalents at October 31, 2024: $4.1 million; shareholders' equity: $4.0 million.

• Research and development expenses increased 58% year-over-year for the quarter and 83% for the six months, mainly due to consulting and FDA submission costs.

• Selling, general, and administrative expenses decreased 4% for the quarter but increased 4% for the six months, driven by higher legal and rent expenses.

Outlook and guidance

• Management believes current cash resources are insufficient to fund operations for the next twelve months, raising substantial doubt about going concern.

• Plans to raise additional capital through equity, debt, or strategic partnerships; no assurance of success.

• FDA clearance for MyoVista wavECG and cloud platform is critical for future commercialization and revenue.

• Phase 2 of MyoVista Insights, adding AI-ECG reporting, targets regulatory clearance in H2 2025.

• Pre-validation work ongoing for first cloud-based AI-ECG algorithm (LVEF ≤40), with FDA validation studies to follow upon success.