HeartBeam(BEAT) - 2024 Q4 - Annual Report

Financial Performance - The company reported a net loss of $19.448 million for the year ended December 31, 2024, compared to a net loss of $14.639 million in 2023, representing a 33% increase in losses [255]. - The company reported a net loss of $19.5 million for the year ended December 31, 2024 [264]. - Net cash used in operating activities for the year ended December 31, 2024, was $14.5 million, compared to $12.1 million for the year ended December 31, 2023 [264][265]. - Net cash provided by financing activities decreased significantly from $24.9 million in 2023 to $0.9 million in 2024 [267]. - The company expects existing cash to be insufficient to fund operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern [261]. Research and Development - Research and development expenses increased by 63% to $11.051 million in 2024, up from $6.798 million in 2023 [255]. - Research and development (R&D) expenses increased by $4.3 million or 63% compared to the same period in 2023, primarily due to increased headcount and clinical-related costs [257]. - The VALID-ECG pivotal study enrolled 198 patients across five clinical sites to validate the HeartBeam 12 Lead ECG Synthesis Software for arrhythmia detection [236]. - The company has acquired approximately one million 12L ECGs to support its AI development efforts [238]. Leadership Changes - The company appointed Timothy Cruickshank as CFO and Robert Eno as CEO in 2024, indicating a strategic leadership transition [250][252]. Patents and Intellectual Property - As of December 31, 2024, the company had 14 issued U.S. patents and 9 pending applications, with patents expected to expire between April 11, 2036, and April 21, 2042 [241]. Capital and Financing - The company entered into a PV Sales Agreement to offer up to $17 million of common stock, with approximately $16.2 million available for issuance as of December 31, 2024 [247]. - The company raised $0.7 million from the sale of common stock and $0.1 million from stock options during the year ended December 31, 2024 [260]. - Subsequent to year-end, the company raised $11.5 million through a public offering [260]. Operating Expenses - Total operating expenses rose by 30% to $19.887 million in 2024, compared to $15.314 million in 2023 [255]. - Net cash used in investing activities was $0.2 million in 2024, consistent with $0.3 million in 2023, primarily for property and equipment purchases [266]. Product Development - The HeartBeam System received FDA clearance on December 13, 2024, marking it as the first FDA cleared cable-free, ambulatory ECG device [231]. - The company plans to initiate an Early Access Program for the HeartBeam System to gather user feedback before commercialization [237]. Cash Position - As of December 31, 2024, the company had approximately $2.4 million in cash and cash equivalents, a decrease of $13.8 million from $16.2 million as of December 31, 2023 [259]. - The company does not have any off-balance sheet arrangements [268].