UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the quarterly period ended
or
For the transition period from ___________ to ___________
Commission File Number:
(Exact Name of Registrant as Specified in its Charter)
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Registrant’s Telephone Number, Including Area Code
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐ |
Accelerated filer ☐ |
Smaller reporting company |
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Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No
Number of shares of common stock outstanding as of May 11, 2026 was
HEARTBEAM, INC.
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”). In particular, statements contained in this Quarterly Report on Form 10-Q, including but not limited to, statements regarding the sufficiency of our cash, our ability to finance our operations and business initiatives and obtain funding for such activities; our future results of operations and financial position, business strategy and plan prospects, or costs and objectives of management for future acquisitions, are forward looking statements. These forward-looking statements relate to our future plans, objectives, expectations and intentions and may be identified by words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “intends,” ’‘targets,” “projects,” “contemplates,” ’‘believes,” “seeks,” “goals,” “estimates,” ’‘predicts,” ’‘potential” and “continue” or similar words. Readers are cautioned that these forward-looking statements are based on our current beliefs, expectations and assumptions and are subject to risks, uncertainties, and assumptions that are difficult to predict, including those identified below, under Part II, Item lA. “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q and those risks identified under Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission on March 12, 2026. Therefore, actual results may differ materially and adversely from those expressed, projected or implied in any forward-looking statements. We undertake no obligation to revise or update any forward-looking statements for any reason.
NOTE REGARDING COMPANY REFERENCES
Throughout this Quarterly Report on Form 10-Q, “HeartBeam,” “Company,” “we,” “us” and “our” refer to HeartBeam, Inc.
FORM 10-Q
TABLE OF CONTENTS
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Page |
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1 |
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Item l. |
1 |
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1 |
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Statements of Operations for the three months ended March 31, 2026 and 2025 |
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Statements of Changes in Stockholders’ Equity for the three months ended March 31, 2026 and 2025 |
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Statements of Cash Flows for the three months ended March 31, 2026 and 2025 |
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5 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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Item 3. |
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Item 4. |
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Item 1. |
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Item 1A. |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 5. |
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Item 6. |
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PART I - FINANCIAL INFORMATION
Item 1. Condensed Unaudited Financial Statements
HEARTBEAM, INC.
Condensed Balance Sheets (Unaudited)
(In thousands, except share data)
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March 31, |
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December 31, |
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Assets |
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Current Assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Prepaid expenses and other current assets |
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Inventory |
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Total Current Assets |
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Property and equipment, net |
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Other assets |
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Total Assets |
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$ |
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$ |
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Liabilities and Stockholders’ Equity |
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Current Liabilities: |
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Accounts payable (includes related party $ |
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$ |
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$ |
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Accrued expenses (includes related party $ |
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Total Current Liabilities |
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Total Liabilities |
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Stockholders’ Equity |
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Preferred stock - $ |
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$ |
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$ |
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Common stock - $ |
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Additional paid in capital |
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Accumulated deficit |
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Total Stockholders’ Equity |
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Total Liabilities and Stockholders’ Equity |
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$ |
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$ |
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See accompanying notes to the condensed unaudited financial statements
1
HEARTBEAM, INC.
Condensed Statements of Operations (Unaudited)
(In thousands, except share and per share data)
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Three months ended |
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2026 |
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2025 |
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Operating Expenses: |
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Selling, general and administrative |
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$ |
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$ |
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Research and development |
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Total operating expenses |
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Loss from operations |
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Other Income and (Expense) |
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Interest income |
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$ |
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$ |
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Total other income |
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Loss before provision for income taxes |
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Income tax provision |
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Net Loss |
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$ |
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$ |
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Net loss per share, basic and diluted |
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$ |
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$ |
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Weighted average common shares outstanding, basic and diluted |
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See accompanying notes to the condensed unaudited financial statements
2
HEARTBEAM, INC.
Condensed Statement of Changes in Stockholders’ Equity (Unaudited)
(In thousands, except share data)
Three months ended March 31, 2026 |
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Additional |
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Total |
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Common Stock |
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Paid-in |
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Accumulated |
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Stockholders' |
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Shares |
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Amount |
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Capital |
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Deficit |
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Equity |
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Balance - January 1, 2026 |
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$ |
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$ |
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$ |
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$ |
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Stock based compensation expense |
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— |
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— |
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— |
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Sale of Common Stock under ATM, net of issuance costs |
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— |
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— |
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Stock issuance upon vesting of restricted stock units |
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— |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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( |
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Balance – March 31, 2026 |
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$ |
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$ |
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$ |
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$ |
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Three months ended March 31, 2025 |
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Additional |
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Total |
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Common Stock |
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Paid-in |
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Accumulated |
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Stockholders' |
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Shares |
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Amount |
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Capital |
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Deficit |
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Equity |
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Balance - January 1, 2025 |
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$ |
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$ |
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$ |
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$ |
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Stock based compensation expense |
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— |
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— |
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— |
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Sale of Common Stock, net of issuance costs |
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— |
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— |
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Stock issuance upon exercise of stock options |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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( |
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Balance – March 31, 2025 |
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$ |
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$ |
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$ |
( |
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$ |
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3
HEARTBEAM, INC.
Condensed Statements of Cash Flows (Unaudited)
(In thousands)
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Three months ended March 31, |
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2026 |
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2025 |
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Cash Flows From Operating Activities |
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Net loss |
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$ |
( |
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$ |
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Adjustments to reconcile net loss to net cash used in operating activities |
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Depreciation |
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Stock based compensation expense |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets |
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( |
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( |
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Inventory |
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( |
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Accounts payable and accrued expenses |
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( |
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( |
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Net cash used in operating activities |
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( |
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( |
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Cash Flows From Investing Activities |
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Purchase of property and equipment |
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( |
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Purchase of short-term investments |
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Net cash used in investing activities |
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( |
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Cash Flows From Financing Activities |
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Proceeds from sale of equity, net of issuance costs |
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Proceeds from sale of equity under ATM, net of issuance costs |
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Net cash provided by financing activities |
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Net (decrease) in cash and restricted cash |
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Cash, cash equivalents and restricted cash – Beginning of period |
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Cash, cash equivalents and restricted cash – Ending of period |
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$ |
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$ |
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Reconciliation of cash, cash equivalents and restricted cash: |
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Cash and cash equivalents |
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$ |
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$ |
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Restricted cash (included in other assets) |
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Total cash, cash equivalents and restricted cash |
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$ |
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$ |
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Supplemental Disclosures of Cash Flow Information: |
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Purchase of property and equipment in accounts payable |
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$ |
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$ |
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Taxes paid |
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$ |
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$ |
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See accompanying notes to the condensed unaudited financial statements
4
HEARTBEAM, INC.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
NOTE 1 – ORGANIZATION AND OPERATIONS
HeartBeam, Inc. (“HeartBeam” or the “Company”) is a medical technology company focused on transforming cardiac care through the power of personalized insights. The Company’s aim is to deliver innovative, higher resolution ambulatory cardiac monitoring solutions that can be used by patients anywhere to enable the detection and monitoring of cardiac disease outside of a healthcare facility. The Company’s ability to develop higher resolution Electrocardiogram (“ECG”) solutions is achieved through the development of a proprietary and patented technology platform that allows the collection of the heart’s electrical activity from three dimensions and synthesize a 12-Lead (“12L”) ECG from these signals.
The Company has validated this technology and has received U.S. Food and Drug Administration (“FDA”) clearance of its initial telehealth products. HeartBeam’s credit card sized 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the 12-Lead ECG synthesis software received FDA clearance in December 2025. During the three months ended March 31, 2025 and March 31, 2026, the HeartBeam System did not generate any revenue.
The Company was incorporated in 2015 as a Delaware corporation. The Company operates as
NOTE 2 – GOING CONCERN AND OTHER UNCERTAINTIES
The Company has incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception. As of March 31, 2026, the Company has cash and cash equivalents of approximately $
Based on the current business plan assumptions, existing financing arrangements and expected cash burn rate, the Company believes that its existing liquidity is insufficient to fund operations for the next twelve months following the issuance of these financial statements. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern.
Therefore, the Company’s continued operations will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings or strategic relationships until sufficient revenue can be generated to achieve positive cash flow from operations as the Company expects no material commercial revenue in 2026. During the period, there were
The Company continues to maintain strong financial discipline as it achieves critical clinical and regulatory milestones and begins a limited commercial launch for the HeartBeam System. Management believes the continued achievement of these milestones will provide the Company the ability to raise additional capital. However, management can provide no assurance that such financing or strategic relationships will be available on acceptable terms, or at all, which if not consummated would likely have a material adverse effect on the Company and its financial statements. The accompanying financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that may result should the Company be unable to continue as a going concern.
The Company is also subject to a number of risks similar to those of early stage companies, including dependence on key individuals and product candidates, the difficulties inherent in the development of a commercial market, competition from larger companies, other technology companies and other technologies.
NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
BASIS OF PRESENTATION
The accompanying condensed unaudited financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America ("US GAAP") and in conformity with the instructions on Form 10-Q and Rule 8-03 of Regulation S-X and the related rules and regulations of the Securities and Exchange Commission (“SEC”) and have been prepared on a basis which assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. In the opinion of management, the unaudited interim condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results of operations for the periods presented. The interim operating results are not necessarily indicative of results that may be expected for any subsequent period. The accompanying condensed unaudited financial statements should be read in conjunction with the Company’s audited annual financial statements and notes thereto included in the Company’s Form 10-K filed with the SEC on March 12, 2026 (“2025 Annual Report”).
5
CASH, CASH EQUIVALENTS AND RESTRICTED CASH
The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash deposits. As of March 31, 2026, the Company has $
USE OF ESTIMATES
The preparation of financial statements in conformity with US GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be based on amounts that differ from those estimates.
NET LOSS PER COMMON SHARE
Basic net loss per share excludes the effect of dilution and is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding.
Diluted net loss per share is computed by giving effect to all potential shares of common stock, including stock options and warrants to the extent dilutive. Basic net loss per share was the same as diluted net loss per share for the three months ended March 31, 2026 and 2025 as the inclusion of all potential common shares outstanding would have an anti-dilutive effect.
In accordance with ASC 260-10-45-13, exercisable penny options are included in the calculation of weighted average basic and diluted earnings per share. Penny options of
The following is a summary of awards outstanding as of March 31, 2026 and 2025, which are not included in the computation of basic and diluted weighted average shares:
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Three months ended |
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2026 |
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2025 |
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Stock options (excluding exercisable penny stock options) |
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Restricted stock units |
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Warrants |
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Total |
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6
Segment Reporting
The Company operates in
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Three months ended March 31, |
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(in thousands) |
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2026 |
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2025 |
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Employee expenses |
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$ |
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$ |
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Research and Development (excluding employee expenses): |
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Consulting and professional fees |
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Clinical study expenses |
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Product development |
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Other* |
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Total Research and development expense |
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$ |
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$ |
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Selling, general and administrative expense (excluding employee expenses): |
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Selling, general and administrative expenses |
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Commercialization readiness expenses |
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Total Selling, general and administrative expense |
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Total operating expenses |
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$ |
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$ |
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*
NOTE 4 – BALANCE SHEET COMPONENTS
PROPERTY AND EQUIPMENT, NET
The following table presents the components of property and equipment, net as of three months ended March 31, 2026 and the year ended December 31, 2025 (in thousands):
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March 31, |
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December 31, |
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2026 |
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2025 |
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Tools |
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$ |
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$ |
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Computer hardware and software |
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Property and equipment, gross |
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Less: accumulated depreciation |
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( |
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( |
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Property and equipment, net |
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$ |
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$ |
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Depreciation was $
7
NOTE 5 – STOCKHOLDERS’ EQUITY
During the three months ended March 31, 2026, there were
WARRANTS
The following is a summary of warrant activity during the three months ended March 31, 2026:
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Number of |
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Weighted |
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Weighted |
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Aggregate |
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Outstanding and exercisable - December 31, 2025 |
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$ |
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$ |
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Issued |
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— |
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— |
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Exercised |
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— |
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— |
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Expired |
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— |
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— |
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Outstanding and exercisable – March 31, 2026 |
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|
|
$ |
|
|
|
|
|
$ |
|
||||
NOTE 6 – STOCK-BASED COMPENSATION
STOCK OPTIONS
The following is a summary of stock option activity during the three months ended March 31, 2026:
|
|
Number of |
|
|
Weighted |
|
|
Average |
|
|
Aggregate |
|
||||
Outstanding – December 31, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Options granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Options exercised |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Options cancelled |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Outstanding – March 31, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable – March 31, 2026 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
The Company estimates the fair values of stock options using the Black-Scholes option-pricing model on the date of grant.
|
|
Three months ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Weighted-average Black-Scholes option pricing model assumptions: |
|
|
|
|
|
|
||
Volatility |
|
|
|
|
||||
Expected term (in years) |
|
|
|
|
||||
Risk-free rate |
|
|
|
|
||||
Expected dividend yield |
|
|
|
|
|
|
||
Weighted average grant date fair value per share |
|
$ |
|
|
$ |
|
||
8
RESTRICTED STOCK UNITS
The following is a summary of RSU’s awards activity during the three months ended March 31, 2026:
|
|
Three months ended March 31, 2026 |
|
|||||
|
|
Numbers of Shares |
|
|
Weighted Average Grant Date Fair value |
|
||
Non-Vested at beginning of period |
|
|
|
|
$ |
|
||
Shares granted |
|
|
|
|
$ |
|
||
Shares vested |
|
|
( |
) |
|
$ |
|
|
Non-vested at the end of period |
|
|
|
|
$ |
|
||
STOCK BASED COMPENSATION
The following is a summary of stock-based compensation expense (rounded):
|
|
Three months ended March 31, |
|
|
|||||
|
|
2026 |
|
|
2025 |
|
|
||
Selling, general and administrative |
|
|
|
|
|
|
|
||
Stock option expense |
|
$ |
|
|
$ |
|
|
||
RSU expense |
|
|
|
|
|
|
|
||
Total Selling, general and administrative expense |
|
|
|
|
|
|
|
||
Research and development |
|
|
|
|
|
|
|
||
Stock option expense |
|
|
|
|
|
|
|
||
RSU expense |
|
|
|
|
|
|
|
||
Total research and development expense |
|
|
|
|
|
|
|
||
Total Stock Based Compensation Expense |
|
$ |
|
|
$ |
|
|
||
As of March 31, 2026, total compensation cost not yet recognized related to unvested stock options and unvested RSUs was approximately $
NOTE 7 – RELATED PARTY TRANSACTIONS
In April 2024, the Company entered into a consulting agreement with
NOTE 8 – COMMITMENTS AND CONTINGENCIES
From time to time, the Company may be involved in certain claims and litigation arising out of the ordinary course and conduct of business. Management assesses such claims and, if it considers that it is probable that an asset had been impaired or a liability had been incurred and the amount of loss can be reasonably estimated, provisions for loss are made based on management’s assessment of the most likely outcome.
Professional Services Agreement
On August 12, 2025, the Company has entered into an agreement with an independent contractor to perform certain services related to development and enhancement of the HeartBeam 12-lead ECG patch. Further on January 14, 2026, the Company entered into an addendum to the original agreement for further services. As per terms of the agreement, the Company will pay the contractor approximately $
9
NOTE 9 - SUBSEQUENT EVENTS
On April 14, 2026, the Company entered into an underwriting agreement to consummate an offering of
The offering closed on April 16, 2026. The Company received approximately $
After giving effect to the exercise of the over-allotment option, the Company sold an aggregate of
Members of the Company’s board and executive leadership participated in the offering, purchasing an aggregate of $
As part of the agreement, the Company agreed to issue to the underwriter, or its designees, warrants to purchase a number of shares of common stock equal to
10
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The following management’s discussion and analysis is intended as a review of significant factors affecting our financial condition and results of operations for the periods indicated. The discussion should be read in conjunction with our condensed unaudited financial statements and the notes presented herein included in this Form 10-Q and the audited financial statements and the other information set forth in the 2025 Form 10-K. When used, the words “believe,” “plan,” “intend,” “anticipate,” “target,” “estimate,” “expect” and the like, and/or future tense or conditional constructions (“will,” “may,” “could,” “should,” etc.), or similar expressions, identify certain of these forward-looking statements. In addition to historical information, the following Management’s Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements that involve risks and uncertainties including, but not limited to, those set forth below under “Risk Factors” and elsewhere herein, and those identified under Part I, Item 1A of our 2025 Form 10-K. Our actual results could differ significantly from those anticipated in these forward-looking statements as a result of certain factors discussed herein and any other periodic reports filed and to be filed with the Securities and Exchange Commission.
Overview
Company Overview
We are a medical technology company focused on transforming cardiac care through the power of personalized insights. Our aim is to deliver innovative, higher resolution ambulatory cardiac monitoring solutions that can be used by patients anywhere to enable the detection and monitoring of cardiac disease outside of a healthcare facility. Our ability to develop higher resolution Electrocardiogram (“ECG”) solutions is achieved through the development of our proprietary and patented technology platform that allows us to collect the heart’s electrical activity from three dimensions and synthesize a 12-Lead (“12L”) ECG from these signals.
We believe our products (“Products” or “Product”) and services will benefit many stakeholders, including patients, healthcare providers, and healthcare payers, and will also address the rapidly growing field of ambulatory cardiac monitoring. As part of our long-term vision, we believe that we are uniquely positioned to play a central role in high-risk Coronary Artery Disease (“CAD”) monitoring, given positive, proof-of-concept data from the initial feasibility studies that demonstrated comparable performance of the HeartBeam System and the standard 12L ECG in ischemia detection. CAD patients are at increased risk for a heart attack or Myocardial Infarction (“MI”). Additionally, our unique portable form-factor will make high-fidelity insights easily accessible, wherever patients are, compared to a standard 12L ECG, which is typically limited to a healthcare setting, working in synergy with standard of care to expedite diagnosis and appropriate intervention.
Our initial product and service offering is the HeartBeam System. The HeartBeam System is the first U.S. Food and Drug Administration (“FDA”) cleared cable-free, ambulatory synthesized 12L ECG that captures the heart’s electrical signals from three dimensions for high-fidelity data collection and advanced diagnostics for arrhythmia assessment. The HeartBeam System is comprised of a credit card sized 3D ECG recording device, a patient application, a physician portal, and powerful cloud-based algorithms. Unlike any single-lead or 6-lead consumer device, HeartBeam’s patented cable-free, 3D technology captures the heart’s electrical signals in three non-coplanar dimensions and synthesizes them into a familiar 12L ECG display, using a personalized transformation matrix. This allows patients to obtain a 12L ECG reading for their arrhythmia from the comfort of home, or wherever they happen to be, representing a new level of convenience and peace of mind. The synthesized 12-lead ECG is promptly reviewed by an on-demand, board-certified cardiologist for arrhythmia assessment.
HeartBeam’s credit card sized 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the additional 12-Lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 2025. During the three months ended March 31, 2025 and March 31, 2026, the HeartBeam System did not generate any revenue.
We are focused on advancing several key initiatives as part of our growth strategy:
11
As of March 31, 2026, we had 17 employees. In January 2026, the Company hired a Chief Commercial Officer, Bryan Humbarger. Mr. Humbarger brings more than 25 years of experience in building and scaling groundbreaking cardiovascular technologies. While initially focused on launching the Company’s FDA-cleared 12L system for arrhythmia assessment, he will lead the Company’s broader commercialization strategy across key growth initiatives, including heart attack detection and the 12L ECG extended wear patch.
We intend to strike a balance of managing our headcount in line with cash resources, while also, at the appropriate time, hiring or engaging additional full-time professionals, employees, and/or consultants in alignment with our growth strategy. To that end, the Company does not anticipate the need to hire a large sales force during the initial launch of its HeartBeam System. We believe that a few well-placed resources will help provide the data points required to effectively invest into a broader launch based around a path to profitable growth.
Although the market is highly competitive for attracting and retaining highly qualified professionals in our industry, we continue our endeavor to find such candidates for our Company. Our management team and additional personnel that we may hire in the future will be primarily responsible for executing and implementing growth opportunities, making tactical decisions related to our strategy and pursuing opportunities to invest in new technologies through strategic partnerships and acquisitions.
12
Recent Developments
Commercial Launch
On May 7, 2026, the Company announced a commercial agreement with Atelier Health, a premier concierge medical practice led by physicians affiliated with Cedars-Sinai Medical Center. The addition of Beverly Hills-based Atelier Health expands HeartBeam’s commercial footprint across four targeted launch markets – New York metro, Dallas, South Florida, and Southern California – completing an initial geographic footprint to advance the Company’s scalable go-to-market strategy in concierge and preventive cardiology.
The collaboration underscores HeartBeam’s positioning within the high-value direct pay healthcare segment where adoption of innovative technologies can occur more rapidly and patients are seeking proactive cardiac insights tailored to their individual risk profiles.
Through its recently announced partnership with ClearCardio™, the Company has also established its initial presence in New York metro, Dallas, and South Florida. Atelier Health extends the network to Southern California, establishing HeartBeam’s initial commercial footprint across its targeted launch markets and providing a foundation for broader national expansion.
The initial agreement with Atelier Health is structured as a Letter of Intent (LOI), outlining the commercial terms and a collaborative rollout plan, including a subscription fee per patient. During the initial deployment phase, HeartBeam and Atelier Health intend to negotiate and execute a definitive agreement.
Pilot Study of First On-Demand 12-Lead ECG Patch to Detect Ischemia Outside the Clinic
On May 11, 2026, the Company announced the initiation of a pilot study evaluating its novel on-demand 12-lead ECG patch in patients with suspected coronary artery disease. The study is being conducted at two leading hospitals in Belgrade, Serbia. The initiation of the pilot study represents a significant step in the development of the HeartBeam patch which has the potential to disrupt the long-term continuous monitor and mobile cardiac telemetry (MCT) markets.
The pilot study will enroll approximately 50 patients with a high risk of coronary artery disease whose resting ECGs show no evidence of ischemia. Each participant will undergo exercise stress testing, a standard diagnostic procedure used to identify ischemic changes. Immediately following exercise, patients will activate the HeartBeam patch to generate a synthesized 12-lead ECG, which will be compared directly with a standard 12-lead ECG recorded at the same time. The results will help inform the Company’s broader regulatory strategy for the HeartBeam patch.
New and Existing Patent Assignments
We believe our intellectual property (“IP”) protects our innovations, and our goal is to become a leader in the ambulatory ECG sector. For some aspects of our proprietary technology, we rely on trade secret protection, while for others we pursue patent protection. It is our view that the combination of these two methods of IP protection maximizes our chances for success.
The Company’s patent portfolio includes twenty-five (25) issued patents worldwide, consisting of seventeen (17) issued patents in the United States and eight (8) issued patents outside of the United States, including one (1) European patent granted with unitary effect under the Unitary Patent system.
In the United States, the Company also has eleven (11) additional pending patent applications. Outside the United States, the Company has twenty-two (22) pending patent applications in jurisdictions including Canada, China, the European Union, Japan, South Korea, and Australia.
The issued patents are expected to expire between April 11, 2036, and April 21, 2042. The pending applications, regardless of publication status, are projected to expire between April 11, 2036, and February 20, 2045.
13
Over the course of 2025 and into early 2026, we were granted a total of eight (8) new patents relating to our compact, mobile three-lead cardiac monitoring technologies and automated diagnostics, methods for atrial fibrillation detection, photoplethysmogram data analysis and presentation, and electrocardiogram patch devices and methods. These patents significantly strengthen HeartBeam’s intellectual property position surrounding its credit card–sized ECG device, reinforcing both the defensive and offensive moats around the company’s core technology. They also expand the application of risk-based diagnostic algorithms across HeartBeam’s wearable device portfolio and cover methods for automatically assessing a patient’s risk of an acute cardiac event by evaluating clinical risk factors and generating a diagnostic report.
In addition, HeartBeam continues to expand its intellectual property portfolio and filed two (2) non-provisional, two (2) provisional and three (3) continuing patent applications throughout 2025, further strengthening the protection of its proprietary technologies.
April Underwritten Offering
On April 14, 2026, the Company entered into an underwriting agreement to consummate an offering of 12,500,000 shares of common stock for gross proceeds of $10.0 million, before deducting underwriting discounts, commissions, and offering expenses. In addition, the Company granted the underwriters a 30-day option to purchase up to an additional 1,875,000 shares to cover overallotments.
The offering closed on April 16, 2026. The Company received approximately $10.0 million in gross proceeds from the offering, before deducting underwriting discounts, commissions and offering expenses. In addition, on May 7, 2026, the underwriter exercised its overallotment in full, resulting in 1,875,000 shares of common stock for $1.5 million in gross proceeds.
After giving effect to the exercise of the over-allotment option, the Company sold an aggregate of 14,375,000 common shares for gross proceeds of approximately $11.5 million, before deducting underwriting discounts, commissions, and offering expenses.
Results of Operations
The following table summarizes our results of operations for the periods presented on our statement of operations data.
|
|
For three months ended March 31 |
|
|
|||||||||||||
|
|
2026 |
|
|
2025 |
|
|
Change |
|
|
% |
|
|
||||
|
|
(In thousands, except percentages) |
|||||||||||||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Selling, general and administrative |
|
$ |
2,346 |
|
|
$ |
2,012 |
|
|
$ |
334 |
|
|
|
17 |
% |
|
Research and development |
|
|
2,370 |
|
|
|
3,492 |
|
|
|
(1,122 |
) |
|
|
(32 |
)% |
|
Total operating expenses |
|
|
4,716 |
|
|
|
5,504 |
|
|
|
(788 |
) |
|
|
(14 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Loss from operations |
|
|
(4,716 |
) |
|
|
(5,504 |
) |
|
|
788 |
|
|
|
(14 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
16 |
|
|
|
20 |
|
|
|
(4 |
) |
|
|
(20 |
)% |
|
Total other income |
|
|
16 |
|
|
|
20 |
|
|
|
(4 |
) |
|
|
(20 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Income tax provision |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Net loss |
|
$ |
(4,700 |
) |
|
$ |
(5,484 |
) |
|
$ |
784 |
|
|
|
(14 |
)% |
|
Summary of Statements of Operations for the three months ended March 31, 2026 compared with the three months ended March 31, 2025:
Selling, General and administrative (“SG&A”) expenses increased by approximately $0.3 million or 17% during the three months ended March 31, 2026 as compared to the three months ended March 31, 2025. The increase in SG&A expense is primarily related to non-cash stock-based compensation expense amounting to $0.4 million driven by additional awards granted since March 31, 2025, $0.1 million related to sales team expenses related to our commercialization efforts, partially offset by a decrease in cash based fees for directors of $0.1 million and a decrease of $0.1 million related to overall reduction of G&A overhead.
14
Research and development expenses (“R&D”) expenses decreased by approximately $1.1 million or 32% during the three months ended March 31, 2026 as compared to the three months ended March 31, 2025. The decrease in R&D expense is primarily related to a decrease in product development and consulting expenses of $0.5 million related to the development of the HeartBeam System, decrease of headcount related costs of $0.3 million during 2025 and decrease of non-cash stock-based compensation expense amounting to $0.3 million resulting from the full vesting of milestone awards as of December 31, 2025.
Other income is related to interest income. The decrease is primarily driven cash by used in operations.
Liquidity and Capital Resources
Our cash requirements are, and will continue to be, dependent upon a variety of factors. We expect to continue devoting capital resources to R&D for the development of software and hardware products and to sales & marketing for the limited launch and commercial strategy of our HeartBeam system.
As of March 31, 2026, we had approximately $2.0 million in cash and cash equivalents, a decrease of $2.4 million from $4.4 million as of December 31, 2025. Subsequent to March 31, 2026, we have raised gross proceeds of $11.5 million from the underwritten offering. Based on our current business plan assumptions and expected cash burn rate, the Company believes that the existing cash is insufficient to fund operations for the next twelve months following the issuance of these financial statements. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern.
In the prior corresponding period ending March 31, 2025, we had approximately $4.4 million in cash and cash equivalents, an increase of $2.0 million from $2.4 million as of December 31, 2024. In addition, the Company held short-term investments of $3.8 million as treasury securities at the balance sheet date. When combined with cash and cash equivalents of $4.4 million, the balance for the Company as of March 31, 2025 was $8.2 million.
Our cash is as follows (in thousands):
|
|
March 31, 2026 |
|
|
December 31, 2025 |
|
||
Cash and cash equivalents |
|
$ |
2,039 |
|
|
$ |
4,380 |
|
Cash flows for the three months ended March 31, 2026 and 2025 (in thousands):
|
|
Three months ended March 31, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Net cash used in operating activities |
|
$ |
(3,610 |
) |
|
$ |
(4,477 |
) |
Net cash used in investing activities |
|
|
(246 |
) |
|
|
(3,760 |
) |
Net cash provided by financing activities |
|
|
1,515 |
|
|
|
10,250 |
|
Operating Activities:
Net cash used in our operating activities of $3.6 million during the three months ended March 31, 2026 is primarily due to our net loss of $4.7 million less $1.3 million in non-cash expenses and $0.2 million of net changes in operating assets and liabilities.
Net cash used in our operating activities of $4.5 million during the three months ended March 31, 2025, is primarily due to our net loss of $5.5 million less $1.1 million in non-cash expenses and $0.1 million of net changes in operating assets and liabilities.
Investing Activities:
Net cash used in investing activities during the three months ended March 31, 2026, of $0.2 million is from the purchase of property and equipment.
Net cash used in investing activities during the three months ended March 31, 2025, of $3.8 million is from the purchase of short-term investments.
Financing Activities
During the three months ended March 31, 2026, net cash provided by financing activities of $1.5 million is primarily from net proceeds from sale of common stock under ATM, net of issuance costs.
15
During the three months ended March 31, 2025, net cash provided by financing activities of $10.3 million is primarily from net proceeds from sale of common stock, net of issuance costs.
Critical Accounting Estimates
There have been no material changes to our critical accounting estimates from the information provided in Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” included in our 2025 Annual Report.
Item 3. Quantitative and Qualitative Disclosures about Market Risk.
We do not hold any derivative instruments and do not engage in any hedging activities.
Item 4. Controls and Procedures.
We carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of our “disclosure controls and procedures” as of the end of the period covered by this report, pursuant to Rules 13a-15(e) and 15d-15(e) under the Exchange Act.
In connection with that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective and designed to provide reasonable assurance that the information required to be disclosed is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms as of March 31, 2026. For the purpose of this evaluation, disclosure controls and procedures means controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms. These disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit is accumulated and communicated to management, including our Principal Executive Officer, and Principal Financial Officer, as appropriate to allow timely decisions regarding required disclosure.
Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Changes in Internal Control
There have been no changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during our fiscal quarter ended March 31, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
16
PART II-OTHER INFORMATION
Item 1. Legal Proceedings.
There are no actions, suits, proceedings, inquiries or investigation before or by any court, public board, government agency, self-regulatory organization or body pending or, to the knowledge of the executive officers of our Company or any of our subsidiaries, threatened against or affecting our Company, our common stock, any of our officers or directors in their capacities as such, in which an adverse decision could have a material adverse effect.
Item 1A. Risk Factors.
Not applicable as we are a smaller reporting company.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
(A) Unregistered Sales of Equity Securities
There were no sales of equity securities sold during the period covered by this Quarterly Report that were not registered under the Securities Act and were not previously reported in a Current Report on Form 8-K filed by the Company.
(B) Use of Proceeds
Not applicable.
(C) Issuer Purchases of Equity Securities
Not applicable.
Item 3. Defaults Upon Senior Securities.
Not applicable
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information.
17
Item 6. Exhibits
The exhibit index set forth below is incorporated by reference in response to this Item 6.
Exhibit Number |
|
Description of Exhibit |
1.1 |
|
|
3.1 |
|
|
3.2 |
|
|
3.3 |
|
|
3.4 |
|
|
4.1 |
|
|
10.1 |
|
|
10.2 |
|
|
31.1* |
|
|
31.2* |
|
|
32.1** |
|
|
32.2** |
|
|
101.INS |
|
XBRL Instance Document+ |
101.SCH |
|
Inline XBRL Taxonomy Extension Schema With Embedded Linkbase Documents |
104 |
|
Cover Page Interactive Data File - The cover page iXBRL tags are embedded within the inline XBRL document+ |
* |
|
Filed herewith. |
** |
|
Furnished herewith. |
+ |
|
Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files in Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections. |
18
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
HEARTBEAM, INC. |
|
|
|
|
|
|
|
By: |
/s/ Robert Eno |
|
|
Name: |
Robert Eno |
|
|
Title: |
Chief Executive Officer |
Dated: May 13, 2026 |
|
|
(Principal Executive Officer) |
|
|
|
|
|
|
By: |
/s/ Timothy Cruickshank |
|
|
Name: |
Timothy Cruickshank |
|
|
Title: |
Chief Financial Officer |
Dated: May 13, 2026 |
|
|
(Principal Financial and Accounting Officer) |
19