HeartBeam, Inc. Q4 FY2024 earnings call

• Received foundational FDA clearance for the HeartBeam, Inc. system in December 2024. • Submitted a 510(k) application in January 2025 for the software that synthesizes a twelve-lead ECG from HeartBeam, Inc. signals. • Clinical results of the VALID ECG study accepted for presentation at the Heart Rhythm Society Annual Meeting in late April 2024. • Results of two additional clinical studies presented at the American Heart Association meeting in November 2024, including a pilot study on arrhythmia detection and a feasibility study on acute coronary conditions. • Commenced early access program to refine workflows and establish an early adopter sales funnel. • Completed an $11.5 million public offering in February 2025. • Go-to-market strategy includes direct patient pay initially through concierge and preventive cardiology practices, and targeting payer plans and healthcare systems later, leveraging new CPT codes for synthesized twelve-lead ECG.

No specific product segments with financial performance and revenue contribution % discussed in the transcript.

• Cash burn aligned to achievement of key milestones, with $14.5 million operating cash outflows in 2024 serving as a baseline for 2025. • G&A costs expected to remain stable. • R&D spend to be opportunistically managed to align with milestones. • Public offering provides runway to execute near-term milestones, with plans to strategically capitalize the business and manage dilution ahead of commercial launch.

• Uncertainties around FDA approval timing for the twelve-lead synthesis software. • Potential impact of political changes on the timely FDA approval process.

Q: Congratulations on receiving your first FDA clearance. What went into your decision to not immediately commercialize upon clearance?

A: Initial clearance was for the system with three-lead output; we plan to commercialize with the twelve-lead synthesis software once cleared, using the early access program to prepare for pilot commercialization.

Q: What are your expectations for cash burn in 2025 and timing of next raise?

A: $14.5 million operating cash outflows in 2024 is a baseline for 2025; G&A costs stable; R&D spend opportunistically managed; capital raise provides runway for near-term milestones, with strategic capitalization planned ahead of commercial launch.

Q: Can you discuss what the pathway or road map is to get to heart attack detection?

A: Stepwise approach with FDA, starting with three-lead system and twelve-lead synthesis for arrhythmia, then expanding to heart attack detection; plan to speak with FDA soon and start a new clinical study on heart attack detection later in 2025.

Q: Is there any competition in the same space?

A: Most consumer devices are one-lead, less suitable for comprehensive cardiac assessment; existing twelve-lead devices are bulky and use traditional electrodes; our IP-protected, cable-free, small device with three-directional ECG is unique.

Q: Are you concerned about the political changes having an effect on getting timely FDA approval?

A: Uncertain environment, but we've been in contact with FDA review team and appear on track with our submission.

Q: Does your initial go-to-market plan include wearables?

A: Device is not a wearable, but there's potential for ecosystem where wearable data feeds into our system for combined insights.

Q: Are you planning to initially commercialize this technology alone or with a partner?

A: Assessing all options, planning initial pilot commercialization in two US markets with own team to demonstrate demand and implement playbook, then considering partnerships.

Q: When is the expected clearance time from FDA for the second clearance?

A: Estimating clearance before end of 2025, but no specific timing given yet; we have good relationships with FDA and encouraging results from VALID ECG study.

Q: Can you give us more details on the early access program?

A: Focus on refining clinical workflows, establishing operational readiness, validating commercial messaging, and building an early adopter funnel, with hundreds of patients expected to be involved.