Heartbeam (BEAT) Q4 2025 earnings summary

Executive summary

• Achieved FDA 510(k) clearance for 12-lead ECG synthesis software in December 2025, following prior clearance for arrhythmia detection in December 2024, enabling limited commercial launch and validating the technology's unique approach.

• Developed two form factors: a credit card-sized device and an on-demand 12-lead patch, both leveraging proprietary 3D signal collection technology, with a working prototype completed.

• Initiated the ALIGN-ACS pilot study in Europe and enrolled first patients, aiming to compare HeartBeam ECG to standard 12-lead ECG for heart attack detection and inform pivotal FDA study.

• Announced a strategic AI collaboration with Mount Sinai to develop advanced algorithms for heart attack assessment and disease prediction, enabling personalized cardiac insights at home.

• Signed first commercial customer, ClearCardio, and focused initial rollout on concierge, preventive cardiology, and direct pay healthcare practices with high willingness to pay.

Financial highlights

• Full year 2025 net loss was $21.0 million, or $0.62 per share; Q4 net loss was $5.3 million, in line with expectations.

• Net cash used in operating activities was $14.0 million for 2025 and $2.9 million for Q4, a 3% year-over-year decrease and a 30% decrease compared to Q4 2024.

• Cash and equivalents totaled $4.4 million at year-end 2025, up from $2.4 million at year-end 2024.

• Projected 2026 gross operating cash outflows of $17–$19 million, including $3–$5 million incremental investments for key milestones.

• Raised $16.6 million in financing activities during FY 2025, including equity sales and ATM offerings.

Outlook and guidance

• Expect baseline operating cash outflows to remain at ~$14 million in 2026, with incremental milestone investments.

• Commercial launch to focus on deep adoption in select practices, aiming for cash flow breakeven at ~30,000 patients.

• 2027 targeted for scaling revenue after validating adoption and refining implementation model.

• R&D spending to step up slightly in H1 2026 due to clinical trials, then return to current levels in H2.

• Extended-wear ECG patch and AI-enabled disease assessment expected to drive future growth.