Heartbeam (BEAT) Q3 2024 earnings summary

Executive summary

• Developed a cable-free, patient-carried 12-lead ECG device using proprietary vector-based and AI technology, targeting a $100B+ U.S. cardiac care market.

• Management team restructured with new CEO, CFO, and Chief AI Scientist to support U.S. commercialization and AI initiatives.

• Nine peer-reviewed studies and over 13,000 recordings support the technology's clinical potential, with upcoming presentations at major conferences.

• Recognized with industry awards, including the MedTech Breakthrough Award and Digital Health Hub Foundation's Rising Star.

• Completed enrollment in the pivotal VALID-ECG study and advanced FDA submissions for the VECG device and synthesized 12L ECG software.

Financial highlights

• Q3 2024 net loss ranged from $4.98M to $5.0M, up 43% year-over-year, with operating expenses rising to $5.07M, driven by R&D and G&A.

• Cash and cash equivalents were $5.8M as of September 30, 2024, down from $16.2M at year-end 2023.

• Net cash used in operating activities for Q3 2024 was $3.3M; for the nine months ended September 30, 2024, $10.3M.

• R&D expenses for Q3 2024 increased to $2.9M, up 78% year-over-year.

• Weighted average shares outstanding for Q3 2024 were approximately 26.8M.

Outlook and guidance

• Confident in achieving foundational FDA clearance soon, enabling an Early Access Program and limited commercial launch in 2025.

• Second FDA 510(k) submission for ECG synthesis software planned after initial clearance.

• No significant revenue expected in 2024 or 2025; focus is on user feedback, refining go-to-market strategy, and pricing models.

• Continued operations depend on raising additional capital or strategic partnerships, with substantial doubt about ability to continue as a going concern.

• Current cash is insufficient to fund operations for the next twelve months.