HeartBeam(BEAT)2024-08-14 20:16Financial Performance - The company reported a net loss of $4.956 million for the three months ended June 30, 2024, compared to a net loss of $3.154 million for the same period in 2023, representing a 57% increase in loss [64]. - Operating expenses totaled $5.090 million for the three months ended June 30, 2024, a 54% increase from $3.312 million in the same period of 2023 [64]. - General and administrative ("G&A") expenses increased by approximately $0.3 million or 7% during the six months ended June 30, 2024, primarily due to non-cash stock-based compensation expense of $0.7 million [66]. - Net cash used in operating activities was $7.0 million during the six months ended June 30, 2024, primarily due to a net loss of $9.5 million [71]. - The company expects no material commercial revenue in 2024 and cannot assure that financing or strategic relationships will be available on acceptable terms [70]. - The company has incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception [69]. - The company’s continued operations will depend on the ability to raise additional capital through various potential sources until sufficient revenue can be generated to achieve positive cash flow from operations [70]. Research and Development - Research and development expenses increased by 92% to $2.844 million for the three months ended June 30, 2024, compared to $1.484 million for the same period in 2023 [64]. - Research and development ("R&D") expenses increased by approximately $1.4 million or 92% during the three months ended June 30, 2024, compared to the same period in 2023 [67]. - R&D expenses increased by approximately $2.1 million or 67% during the six months ended June 30, 2024, compared to the same period in 2023 [68]. - The company completed patient enrollment in the VALID-ECG study with a total of 198 patients, aimed at validating the AIMIGo 12L ECG Synthesis Software [52]. - The company has acquired approximately one million 12L ECGs to support its AI development efforts [54]. Regulatory and Product Development - The company has filed a 510(k) submission with the FDA for the HeartBeam AIMIGo device and is in the substantive review phase [50]. - The company plans to launch the AIMIGo 3L system by the end of 2024, which will provide valuable user feedback [53]. - The company has been granted two new U.S. patents in 2024, bringing the total to 13 issued U.S. patents [58]. Financing and Capital - The company entered into a PV Sales Agreement to offer up to $17 million of its common stock, with approximately $16.9 million available for issuance as of June 30, 2024 [60]. Awards and Recognition - The company was awarded the "Best New ECG Technology Solution" at the 8th annual MedTech Breakthrough Awards [62].