HeartBeam(BEAT) - 2025 Q2 - Quarterly Report

Part I - Financial Information Condensed Unaudited Financial Statements The company reported total assets of $6.0 million and total liabilities of $1.8 million as of June 30, 2025, incurring a net loss of $10.5 million and using $7.9 million in operating cash flow, raising substantial doubt about its going concern ability Condensed Balance Sheet Data (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $3,256 | $2,377 | | Total Current Assets | $5,361 | $2,770 | | Total Assets | $5,981 | $3,276 | | Total Current Liabilities | $1,799 | $1,622 | | Total Liabilities | $1,799 | $1,622 | | Total Stockholders' Equity | $4,182 | $1,654 | Condensed Statement of Operations Data (in thousands, except per share data) | | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $6,818 | $5,272 | | General and administrative | $3,720 | $4,602 | | Loss from operations | $(10,538) | $(9,874) | | Net Loss | $(10,458) | $(9,562) | | Net loss per share, basic and diluted | $(0.32) | $(0.36) | Condensed Statement of Cash Flows Data (in thousands) | | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,922) | $(7,013) | | Net cash used in investing activities | $(1,899) | $(98) | | Net cash provided by financing activities | $10,700 | $84 | | Net increase (decrease) in cash | $879 | $(7,027) | - The company has incurred losses and negative cash flows from operations each year since inception. As of June 30, 2025, cash, equivalents, and short-term investments were approximately $5.1 million[29] - Management believes existing liquidity is insufficient to fund operations for the next twelve months, which raises substantial doubt about the company's ability to continue as a going concern[30] Management's Discussion and Analysis of Financial Condition and Results of Operations HeartBeam, a pre-commercial medical technology company, received FDA clearance for its HeartBeam System and filed for 12L ECG synthesis software, but faces going concern doubts due to recurring losses and insufficient liquidity - The HeartBeam System received FDA clearance on December 13, 2024. A subsequent 510(k) application for software to synthesize a 12L ECG was filed in January 2025[60][61] - The VALID-ECG pivotal study successfully met its clinical endpoints, showing a 93.4% overall diagnostic agreement between HeartBeam's synthesized 12L ECG and a standard 12L ECG for arrhythmia assessment[63] - In April 2025, HeartBeam announced a strategic collaboration with AccurKardia to integrate its FDA-cleared automated ECG interpretation platform, aiming to expedite product development and reduce costs[66][77] - The company has an At-the-Market (ATM) sales agreement to sell up to $17.0 million in common stock. As of the report date, approximately $15.6 million remained available for issuance under this agreement[31][76] Results of Operations Total operating expenses increased by 7% to $10.5 million for the six months ended June 30, 2025, driven by a 29% rise in R&D expenses, partially offset by a 19% decrease in G&A costs Comparison of Operating Expenses (in thousands) | Expense Category | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | General and administrative | $3,720 | $4,602 | $(882) | (19)% | | Research and development | $6,818 | $5,272 | $1,546 | 29% | | Total operating expenses | $10,538 | $9,874 | $664 | 7% | - The decrease in G&A expenses for the six months ended June 30, 2025, was primarily due to a $0.8 million reduction in non-cash stock-based compensation and a $0.2 million decrease in consultant costs[81] - The increase in R&D expenses for the six months ended June 30, 2025, was mainly driven by a $1.0 million increase in product development, a $1.1 million increase in headcount costs, and a $0.8 million increase in stock-based compensation[83] Liquidity and Capital Resources As of June 30, 2025, the company's $5.1 million in cash and investments are insufficient for future operations, necessitating additional capital to address going concern doubts - The company's existing cash and short-term investments of approximately $5.1 million as of June 30, 2025, are insufficient to fund operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern[86] - Continued operations depend on raising additional capital, as the company expects no material commercial revenue in 2025[87] Cash Flow Summary (in thousands) | | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(7,922) | $(7,013) | | Net cash used in investing activities | $(1,899) | $(98) | | Net cash provided by financing activities | $10,700 | $84 | - In February 2025, the company raised approximately $10.3 million in net proceeds from a public offering of common stock[45] Quantitative and Qualitative Disclosures About Market Risk The company does not hold derivative financial instruments nor engage in hedging activities - The company does not hold derivative instruments or engage in hedging activities[95] Controls and Procedures Management concluded the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[97] - No material changes to internal control over financial reporting were identified during the fiscal quarter ended June 30, 2025[99] Part II - Other Information Legal Proceedings The company is not involved in any pending or threatened legal proceedings that could materially adversely affect its business or financial condition - There are no pending or threatened legal actions against the company that could have a material adverse effect[101] Risk Factors This section is not applicable as HeartBeam, Inc. is classified as a smaller reporting company - Not applicable as the company is a smaller reporting company[102] Unregistered Sales of Equity Securities and Use of Proceeds No unregistered equity securities were sold during the period covered by this report - No equity securities were sold during the period that were not registered under the Securities Act[103] Exhibits This section lists filed exhibits, including corporate governance documents, equity incentive plan amendments, and CEO/CFO certifications - Filed exhibits include the Third Amendment to the 2022 Equity Incentive Plan and Sarbanes-Oxley Act certifications from the CEO and CFO[109]