Heartbeam (BEAT) Q3 2025 earnings summary

Executive summary

• Achieved foundational FDA 510(k) clearance for the HeartBeam System for arrhythmia assessment in December 2024, with 12-lead ECG synthesis software clearance anticipated by Q4 2025.

• Entered partnerships with HeartNexus and AccurKardia for on-demand, board-certified cardiologist ECG interpretation and automated ECG analysis, supporting commercial launch.

• Early access (beta) program provided valuable feedback, enhancing onboarding and user experience ahead of commercial launch.

• Presented pivotal clinical study results showing 93.4% diagnostic agreement with standard 12-lead ECGs and advanced AI algorithm data at major conferences.

• Expanded IP portfolio to 24 issued patents worldwide, recognized as #2 globally in 12-lead ECG innovation.

Financial highlights

• Q3 2025 net loss was $5.3 million, or $0.15 per share, with operating expenses of $5.29 million and cash used in operations down 8% quarter-over-quarter.

• Cash and cash equivalents at September 30, 2025, were $1.9 million, down from $2.4 million at year-end 2024.

• Net cash used in operating activities for Q3 2025 was $3.2 million; for the nine months ended September 30, 2025, $11.1 million.

• Raised $10.3 million from a public offering and $0.5 million from ATM sales during the nine months ended September 30, 2025.

• Weighted average shares outstanding for Q3 2025: 34.4 million.

Outlook and guidance

• FDA clearance for 12-lead ECG synthesis software expected by end of 2025, enabling initial commercial launch in early 2026.

• Initial commercialization to focus on two U.S. regions with prominent concierge and preventive cardiology practices, with national expansion to follow.

• No material commercial revenue expected in 2025; more meaningful sales and user growth anticipated in H2 2026 and into 2027.

• Plans to expand indications to myocardial infarction detection, with ongoing FDA discussions and proof-of-concept studies completed.

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