HeartSciences (HSCS) Q1 2025 earnings summary

Executive summary

• Focused on AI-based ECG technology, advancing both the MyoVista wavECG device and Insights cloud platform, with the first cloud-based AI-ECG algorithm developed in Q1 FY2025.

• Preparing for FDA submission of MyoVista wavECG device in Q1 2025 and cloud platform/algorithms in mid-to-late 2025, with validation studies nearing completion.

• Entered collaborations with Mount Sinai and Rutgers for AI-ECG algorithm development and commercialization.

• Selected to demonstrate MyoVista wavECG at the UN General Assembly Digital Health Symposium, highlighting its transformative healthcare potential.

• Expanded key opinion leader network and received positive clinical feedback in Europe.

Financial highlights

• Net loss for the quarter ended July 31, 2024 was $2.1 million, up 50% year-over-year from $1.4 million.

• Research and development expenses increased 117% to $1.2 million, mainly due to consulting and FDA submission costs.

• Cash and cash equivalents were $4.3 million as of July 31, 2024; shareholders' equity was $5.9 million.

• Post-quarter, balance sheet strengthened with $1.9 million in non-dilutive financing and a $500,000 loan note extension to September 2025.

• No revenues reported for Q1 FY2025; business remains pre-commercialization.

Outlook and guidance

• Current cash is insufficient to fund operations for the next twelve months; substantial doubt exists about going concern.

• Plans to raise additional capital through equity, debt, or strategic partnerships.

• MyoVista Insights Platform Phase 1 expected to complete by end of 2024; FDA submission for software-based device targeted for H2 2025.

• FDA 510(k) submission for MyoVista wavECG device remains on track for Q1 2025.

• Company aims to capitalize on a projected $25 billion per year market for AI-ECG solutions.