HeartBeam flags going-concern doubt with $6.07M cash
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
HeartBeam, Inc. reported a third-quarter 2026 net loss of $3.010 million, versus $5.255 million a year earlier; the HeartBeam System generated no revenue in the quarter or first nine months of 2026. Nine-month net loss was $12.749 million, compared with $15.713 million. Cash and cash equivalents were $6.065 million as of September 30, 2026, and nine-month operating cash use was $9.540 million. Management said liquidity was insufficient for the next 12 months, raising substantial doubt about the company’s ability to continue as a going concern.
FDA granted Breakthrough Device Designation for heart attack assessment on October 5, and HeartBeam was accepted into FDA’s Total Product Life Cycle Advisory Program on October 26. ALIGN-ACS data showed 81.8% specificity versus 71.4% for standard 12-lead ECG, with comparable sensitivity; 132 patients enrolled. HEADSTART-ACS completed enrollment with 486 patients; analysis is underway and results are expected at a cardiology conference in 2027.
In the fourth quarter, HeartBeam sold 5,799,795 shares through its ATM for approximately $4.0 million in net proceeds; approximately $21 million remained available for issuance as of the financial statement issuance date, subject to limitations including authorized shares. Nasdaq’s compliance period runs through December 28, 2026.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointThird-quarter net loss decreased 43% to $3.010 million.
Negative
- Major pointManagement said $6.1 million in cash and cash equivalents was insufficient for the next 12 months.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Nasdaq bid-price deadline: December 28, 2026; noncompliance may risk delisting.
Filing Explained
As of September 30, 2026, 57,513,001 shares were outstanding, versus 40,117,404 at December 31, 2025, increasing the share base and diluting existing holders absent offsets.
A Form 10-Q is an unaudited quarterly report. HeartBeam reports that its April offering closed with 14,375,000 common shares sold, and that 970,467 shares were sold through its ATM during the nine months ended
The April offering also resulted in 718,750 underwriter warrants, exercisable at
Key Figures
Key Terms
going concern financial
At-The-Market Equity Offering Sales Agreement financial
Breakthrough Device Designation regulatory
Total Product Life Cycle Advisory Program (TAP) regulatory
specificity medical
acute coronary syndrome medical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much cash did HeartBeam (BEAT) have as of September 30, 2026?
What were BEAT’s ALIGN-ACS results for heart attack assessment?
How much did HeartBeam (BEAT) raise through its ATM in the fourth quarter of 2026?
When does BEAT need to regain Nasdaq’s minimum bid-price compliance?
How many patients were enrolled in HeartBeam’s (BEAT) HEADSTART-ACS study?
AI-generated analysis. How Rhea-AI works. Not financial advice.
Table of Contents
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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State or Other Jurisdiction of Incorporation or Organization |
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I.R.S. Employer Identification No. |
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Address of Principal Executive Offices |
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Zip Code |
(
Registrant’s Telephone Number, Including Area Code
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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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, a 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 Exchange Act). Yes ☐ No
Number of shares of common stock outstanding as of November 10, 2026 was
Table of Contents
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 elsewhere in this Quarterly Report on Form 10-Q and those risks identified under Part I, Item 1A. “Risk Factors” 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.
Table of Contents
FORM 10-Q
TABLE OF CONTENTS
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Page |
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PART I-FINANCIAL INFORMATION |
1 |
Item 1. |
Condensed Unaudited Financial Statements |
1 |
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Balance Sheets as of September 30, 2026 and December 31, 2025 |
1 |
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Statements of Operations for the three and nine months ended September 30, 2026 and 2025 |
2 |
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Statements of Changes in Stockholders’ Equity for the three and nine months ended September 30, 2026 and 2025 |
3 |
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Statements of Cash Flows for the nine months ended September 30, 2026 and 2025 |
5 |
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Notes to the Condensed Unaudited Financial Statements |
6 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
12 |
Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
19 |
Item 4. |
Controls and Procedures |
19 |
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PART II-OTHER INFORMATION |
20 |
Item 1. |
Legal Proceedings |
20 |
Item 1A. |
Risk Factors |
20 |
Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
20 |
Item 3. |
Defaults Upon Senior Securities |
20 |
Item 4. |
Mine Safety Disclosures |
20 |
Item 5. |
Other Information |
20 |
Item 6. |
Exhibits |
21 |
SIGNATURES |
22 |
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Table of Contents
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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September 30, |
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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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Commitments and Contingencies (Note 8) |
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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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( |
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( |
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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
Table of Contents
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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Nine months ended |
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2026 |
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2025 |
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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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$ |
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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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( |
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( |
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( |
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( |
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Other Income and (Expense) |
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Interest income |
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Other income, net |
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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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( |
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( |
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( |
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( |
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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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$ |
( |
) |
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$ |
( |
) |
Net loss per share, basic and diluted |
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$ |
( |
) |
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$ |
( |
) |
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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
Table of Contents
HEARTBEAM, INC.
Condensed Statement of Changes in Stockholders’ Equity (Unaudited)
(In thousands, except share data)
Three months ended September 30, 2026 |
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Common |
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Additional |
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Total |
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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 - July 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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Stock issuance upon vesting of restricted stock units |
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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 – September 30, 2026 |
|
|
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$ |
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$ |
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$ |
( |
) |
|
$ |
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Three months ended September 30, 2025 |
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Common |
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Additional |
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Total |
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Stock |
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Paid-in |
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Accumulated |
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Stockholders' |
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|||||||||||
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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 - July 1, 2025 |
|
|
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|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Stock based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
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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 exercise of stock options |
|
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— |
|
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— |
|
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|||
Stock issuance upon vesting of restricted stock units |
|
|
|
|
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— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance – September 30, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
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3
Table of Contents
HEARTBEAM, INC.
Condensed Statement of Changes in Stockholders’ Equity (Unaudited)
(In thousands, except share data)
Nine months ended September 30, 2026 |
|
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Common |
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Additional |
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Total |
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Stock |
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Paid-in |
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Accumulated |
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Stockholders' |
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||||||||
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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 |
|
|||||
Balance - January 1, 2026 |
|
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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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Sale of Common Stock under ATM, net of issuance costs |
|
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|
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— |
|
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|
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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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|||
Stock issuance upon vesting of restricted stock units |
|
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— |
|
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|
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— |
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Stock issuance for services |
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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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( |
) |
|
|
( |
) |
Balance - September 30, 2026 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
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Nine months ended September 30, 2025 |
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Common |
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Additional |
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Total |
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||||||||
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Stock |
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Paid-in |
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Accumulated |
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Stockholders' |
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||||||||
|
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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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|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
Stock based compensation expense |
|
|
— |
|
|
|
— |
|
|
|
|
|
|
— |
|
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|
||
Sale of Common Stock, net of issuance costs |
|
|
|
|
|
— |
|
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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 exercise of stock options |
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— |
|
|
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|
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— |
|
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|||
Stock issuance upon vesting of restricted stock units |
|
|
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
Balance – September 30, 2025 |
|
|
|
|
$ |
|
|
$ |
|
|
$ |
( |
) |
|
$ |
|
||||
See accompanying notes to the condensed unaudited financial statements
4
Table of Contents
HEARTBEAM, INC.
Condensed Statements of Cash Flows (Unaudited)
(In thousands)
|
|
Nine months ended September 30, |
|
|||||
|
|
2026 |
|
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2025 |
|
||
Cash Flows From Operating Activities |
|
|
|
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|
||
Net loss |
|
$ |
( |
) |
|
$ |
( |
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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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Stock issuance upon vesting of restricted stock units |
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Stock issuance for services |
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Changes in operating assets and liabilities: |
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Prepaid expenses and other current assets |
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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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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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Maturities of short-term investments |
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( |
) |
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Net cash used in investing activities |
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( |
) |
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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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Proceeds from exercise of stock options |
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Net cash provided by financing activities |
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Net increase / (decrease) in cash and restricted cash |
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|
( |
) |
|
Cash, cash equivalents and restricted cash – Beginning of period |
|
|
|
|
|
|
||
|
|
|
|
|
|
|
||
Cash, cash equivalents and restricted cash – Ending of period |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Reconciliation of cash, cash equivalents and restricted cash: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
|
|
$ |
|
||
Restricted cash (included in other assets) |
|
|
|
|
|
|
||
Total cash, cash equivalents and restricted cash |
|
$ |
|
|
$ |
|
||
|
|
|
|
|
|
|
||
Supplemental Disclosures of Cash Flow Information: |
|
|
|
|
|
|
||
Purchase of property and equipment in accounts payable |
|
$ |
|
|
$ |
|
||
Taxes paid |
|
$ |
|
|
$ |
|
||
See accompanying notes to the condensed unaudited financial statements
5
Table of Contents
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, high 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 the synthesis of 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 and nine months ended September 30, 2026 and September 30, 2025, 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 September 30, 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 does not expect material commercial revenue in 2026. On August 14, 2026, the Company entered into an At-The-Market Equity Offering Sales Agreement (the “Sales Agreement”) with Titan Partners Securities LLC, as sales agent, pursuant to which the Company may sell, from time to time, an aggregate of up to $
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.
6
Table of Contents
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”).
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 September 30, 2026, the Company had $
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 and nine months ended September 30, 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 September 30, 2026 and 2025, which are not included in the computation of basic and diluted weighted average shares:
|
|
Three and nine months ended |
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|||||
|
|
2026 |
|
|
2025 |
|
||
Stock options (excluding exercisable penny stock options) |
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|
||
Restricted stock units |
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|
||
Warrants |
|
|
|
|
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|
||
Performance-based restricted stock units |
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|
||
Total |
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||
7
Table of Contents
SEGMENT REPORTING
The Company operates in
|
|
Three months ended September 30, |
|
|
Nine months ended September 30, |
|
||||||||||
(in thousands) |
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Employee expenses |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
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 |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
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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|
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|
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|
||||
Total operating expenses |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
||||
*
NOTE 4 – BALANCE SHEET COMPONENTS
PROPERTY AND EQUIPMENT, NET
The following table presents the components of property and equipment, net as of September 30, 2026 and the year ended December 31, 2025 (in thousands):
|
|
September 30, |
|
|
December 31, |
|
||
|
|
|
|
|
|
|
||
Tooling |
|
$ |
|
|
$ |
|
||
Computer hardware and software |
|
|
|
|
|
|
||
Property and equipment, gross |
|
|
|
|
|
|
||
Less: accumulated depreciation |
|
|
( |
) |
|
|
( |
) |
Property and equipment, net |
|
$ |
|
|
$ |
|
||
Depreciation expense was $
8
Table of Contents
NOTE 5 – STOCKHOLDERS’ EQUITY
COMMON STOCK
During the nine months ended September 30, 2026, there were
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 $
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
WARRANTS
In connection with the April 2026 offering on April 14, 2026, on May 7, 2026, the Company issued
The following is a summary of warrant activity during the nine months ended September 30, 2026:
|
|
Number of |
|
|
Weighted |
|
|
Weighted |
|
|
Aggregate |
|
||||
Outstanding and exercisable - December 31, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Issued |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Exercised |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Expired |
|
|
|
|
|
|
|
|
— |
|
|
|
— |
|
||
Outstanding and exercisable – September 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
9
Table of Contents
NOTE 6 – STOCK-BASED COMPENSATION
STOCK OPTIONS
The following is a summary of stock option activity during the nine months ended September 30, 2026:
|
|
Number of |
|
|
Weighted |
|
|
Average |
|
|
Aggregate |
|
||||
Outstanding – December 31, 2025 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Options granted |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Options exercised |
|
|
( |
) |
|
|
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|
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|
|
|
|||
Options cancelled |
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|||
Outstanding – September 30, 2026 |
|
|
|
|
$ |
|
|
|
|
|
$ |
|
||||
Exercisable – September 30, 2026 |
|
|
|
|
|
|
|
|
|
|
|
|
||||
The Company estimates the fair values of stock options using the Black-Scholes option-pricing model on the date of grant.
|
|
Nine months ended September 30, |
|
|||||
|
|
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 |
|
$ |
|
|
$ |
|
||
RESTRICTED STOCK UNITS
On June 15, 2026, the Board approved grants of
The following is a summary of RSU awards activity during the nine months ended September 30, 2026:
|
|
Nine months ended September 30, 2026 |
|
|||||
|
|
Numbers of Shares |
|
|
Weighted Average Grant Date Fair value |
|
||
Non-Vested at beginning of period |
|
|
|
|
$ |
|
||
Shares granted |
|
|
|
|
|
|
||
Shares vested |
|
|
( |
) |
|
|
|
|
Shares cancelled |
|
|
( |
) |
|
|
|
|
Non-vested at the end of period |
|
|
|
|
$ |
|
||
10
Table of Contents
PERFORMANCE-BASED RESTRICTED STOCK UNITS
On June 15, 2026, the Board approved a performance-based restricted stock unit (“PRSU”) award under the Company’s 2022 Equity Incentive Plan to Branislav Vajdic, the Company’s President, Founder, and Director covering
STOCK BASED COMPENSATION
The following is a summary of stock-based compensation expense (rounded):
|
|
Three months ended |
|
|
Nine months ended |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
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 September 30, 2026, total compensation cost not yet recognized related to unvested stock options, unvested RSUs, and unvested PRSUs 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.
The Company has entered into an agreement for future research work with the term ranging up to one year. This agreement commits the Company to approximately $
NOTE 9 – SUBSEQUENT EVENTS
In the fourth quarter of 2026, the Company issued
11
Table of Contents
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 Annual Report. 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 elsewhere herein, and those identified under Part I, Item 1A of our 2025 Annual Report. 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 12-lead ECG in ischemia detection. CAD patients are at increased risk for a heart attack or Myocardial Infarction (“MI”). Additionally, our unique portable form-factors will make high-fidelity insights easily accessible, wherever patients are, compared to a standard 12-lead ECG, which is typically limited to a healthcare setting. This will allow our technology to work in synergy with the standard of care to expedite diagnosis and appropriate intervention.
We believe that our system records the most info-rich ambulatory ECG signal available, enabled by our patented 3D signal technology. Our Company is founded on one platform, powered by this 3D signal technology, with many form factors envisioned for the future beyond the currently U.S. Food and Drug Administration (“FDA”) cleared credit card size form factor. This platform technology is designed for portable devices that can be used wherever the patient is to deliver actionable heart intelligence. Physicians will be able to identify cardiac health trends and acute conditions and direct patients to the appropriate care – all outside of a medical facility, thus redefining the future of cardiac health management.
The Company is focused on executing on a $40 billion cardiac monitoring platform opportunity, going after a patient pool of more than 50 million people across multiple applications and form factors.
Our initial form factor and service offering is the HeartBeam System. The HeartBeam System is the first FDA-cleared cable-free, ambulatory device that can synthesize a 12-lead ECG by capturing the heart’s electrical signals from three dimensions for high-fidelity data collection 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 algorithm for synthesis. 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 12-lead ECG display, using a personalized transformation matrix. This allows patients to obtain a 12-lead 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 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 (K231424) and the additional 12-Lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 2025 (K250258). During the nine months ended September 30, 2025 and September 30, 2026, the HeartBeam System did not generate any revenue.
Future form factors include an extended wear patch monitor and a ruggedized, industrial form factor for rural and international usage.
12
Table of Contents
Significant advancements within our Heart Attack Detection program, a key expansion of the platform
We are pursuing an expansion of our cleared indications for heart attack detection, or myocardial infarction (MI) detection, a market opportunity that is four times larger than the arrhythmia market.
MI Detection represents a major expansion opportunity to tens of millions of patients in the U.S. More than 20 million U.S. adults are at elevated risk of a heart attack, yet the standard 12-lead ECG used to evaluate suspected MI is largely confined to hospitals and clinics. HeartBeam is developing its heart attack assessment capability on the same 3D ECG platform behind its FDA-cleared arrhythmia product and does not currently anticipate the need for new hardware development. The Company estimates the MI market opportunity at approximately $15 billion within our broader cardiac platform opportunity of more than $40 billion.
When a heart attack occurs, time to treatment is critical. Yet, many patients delay seeking emergency care after symptoms begin, often because they are unsure whether their symptoms require immediate medical attention. HeartBeam’s goal is to help physicians assess a suspected heart attack remotely and accelerate access to emergency care.
The Company’s work towards an expanded indication is supported by a growing body of clinical evidence and continued de-risking of the regulatory pathway.
In June 2026, the Company completed enrollment in the ALIGN-ACS pilot study, ahead of its previously communicated Q3 2026 timeline. The study enrolled 132 patients presenting with chest pain across two emergency department sites in Belgrade, Serbia. Patients were evaluated using both a standard 12-lead ECG and the 3D ECG recorded with HeartBeam device, and both results compared with each patient’s final diagnosis at discharge.
Positive results from the ALIGN-ACS pilot study were presented by Graham Nichol, MD, MPH, FRCP(C), of the University of Washington, at the Transcatheter Cardiovascular Therapeutics (TCT) 2026 conference. HeartBeam’s 3D ECG technology was shown to be as accurate as the standard 12-Lead ECG. The device demonstrated higher specificity than standard 12-lead ECG (81.8% vs. 71.4%), with comparable sensitivity. HeartBeam ECGs were interpreted more consistently across cardiologists than standard 12-lead ECGs.
The findings will be used to inform the design of, and refine operational assumptions for the Company’s planned U.S pivotal study and support a future FDA submission to expand the HeartBeam System’s indication to include heart attack detection.
In October 2026, the Company received FDA Breakthrough Designation for Heart Attack Assessment. The designation recognizes the potential of HeartBeam’s 3D ECG technology to help physicians assess suspected heart attacks outside the hospital and Breakthrough Designation provides prioritized FDA interaction as HeartBeam advances toward a pivotal study. In addition, this designation positions the Company to pursue an expedited Medicare coverage pathway.
Refer to the Recent Developments section of this report for additional details on the Company’s recent clinical and regulatory advancements.
Advancing our limited commercial launch in order to provide key learnings
On the back of our recent FDA Clearance for the HeartBeam System, we initiated a market introduction in 2026, focusing on select concierge and preventive cardiology groups that have proactively signaled strong interest in adopting HeartBeam’s technology. This limited market release will enable the Company to validate real-world performance and establish reference sites for broader commercialization.
The Company’s initial commercial footprint focuses on four key markets – New York metro, Dallas, South Florida, and Southern California. The goal of the limited commercial launch in the arrhythmia market is to generate real-world deployment evidence related to practice and patient workflows in order to support a full commercial launch in the MI Detection market. We have leveraged these learnings at our early adopter sites to create more efficient site and patient onboardings, as well as stand up our Customer Success workflow. Additionally, we are executing on a program that includes HeartBeam as part of the patient’s clinical management within a practice. This will help to develop real world evidence and clinical validation to support a scalable go-to-market strategy.
As of September 30, 2026, we had 14 employees.
We intend to strike a balance of managing our headcount in line with cash resources. To that end, the Company does not anticipate the need to hire a large sales force during the initial launch of its HeartBeam System. The Company is focused on rapidly advancing the clinical and regulatory program towards an expanded indication for heart attack detection. 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.
13
Table of Contents
Recent Developments
HeartBeam Received FDA Breakthrough Device Designation for Heart Attack Assessment
On October 5, 2026, the Company received FDA Breakthrough Device Designation for Heart Attack Assessment. The FDA Breakthrough Devices Program is intended to provide patients and clinicians with more timely access to technologies that may offer more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions.
The designation provides the Company with prioritized FDA review and interaction throughout development, including collaboration on the clinical and regulatory path toward potential clearance. The designation recognizes the potential of HeartBeam’s 3D ECG technology, which captures the heart’s electrical signals from three non-coplanar dimensions, to enable physicians to evaluate signs of a possible heart attack (myocardial infarction, or MI) when symptoms start, wherever the patient may be. The FDA granted the designation within 30 days of HeartBeam’s request, well ahead of the agency’s 60-day statutory review period. This Breakthrough Device Designation was supported by proof-of-concept data presented at the 2025 American Heart Association Scientific Sessions and findings from the 132-patient ALIGN-ACS pilot study. The Company expects to seek FDA alignment on the design of a multicenter pivotal study in the coming months and anticipates beginning patient enrollment shortly thereafter. If successful, the study is intended to support a future submission to expand the HeartBeam System’s indications to include heart attack assessment.
HeartBeam Joins European EXIT-CVD Research Consortium to Advance At-Home ECG Monitoring for Early Detection of Acute Coronary Syndrome (ACS) in High-Risk Patients
On October 15, 2026, the Company announced that it joined the European EXIT-CVD Research Consortium to advance at-home ECG monitoring for the early detection of Acute Coronary Syndrome (ACS) in high-risk patients. The initiative is co-funded by the European Union’s Innovative Health Initiative and led by University Medical Center Groningen and Royal Philips. HeartBeam joins Philips, Medtronic, GE HealthCare and other global healthcare leaders. HeartBeam will lead the HEART-CHECK Study, one of the project’s 22 studies. HEART-CHECK is a hybrid effectiveness-implementation study that will evaluate the HeartBeam System, on an investigational basis only, for early detection and triage of acute coronary syndrome in high-risk patients recently discharged after ACS.
HEADSTART-ACS Completes Enrollment Ahead of Schedule, the Largest Heart Attack Detection Study to Date Using HeartBeam Technology
On October 21, 2026, the Company announced completion of enrollment ahead of schedule in the HEADSTART-ACS study, the largest heart attack detection study to date using HeartBeam’s technology. The HEADSTART-ACS study was conducted in collaboration with Indonesia’s National Cardiovascular Center, Harapan Kita in Jakarta, Indonesia. The study enrolled 486 patients, with data analysis underway and results anticipated to be presented at a cardiology conference in 2027. The study evaluates the diagnostic accuracy of the HeartBeam ambulatory 3D ECG System for detecting acute coronary syndrome in emergency department patients, compared with a standard 12-lead ECG, and may inform efforts to extend clinical-grade ECG assessment to geographically dispersed communities.
With the HEADSTART-ACS and ALIGN-ACS studies, HeartBeam has clinical experience with more than 600 patients in heart attack detection, ahead of its U.S. pivotal study planned for Q1 2027. Additionally, Indonesia is the world’s fourth most populous country, representing a strategically significant market of 288 million people.
HeartBeam Accepted into FDA TAP
On October 26, 2026, the Company announced the HeartBeam System was accepted into the FDA's Total Product Life Cycle Advisory Program (TAP).
TAP is a voluntary program established by the Center for Devices and Radiological Health (CDRH) to accelerate patient access to high-quality, safe, and effective Breakthrough medical devices. Designed to foster early and frequent interactions during medical device development, TAP assigns dedicated FDA advisors who provide proactive regulatory support and coordinate expedited feedback timelines. Additionally, the program connects innovators directly with non-FDA stakeholders—such as patient advocacy groups, professional specialty societies, and health insurance payers—to help developers navigate reimbursement, clinical adoption, and commercialization challenges early in the device development lifecycle.
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ALIGN-ACS Data Presented at TCT 2026
On November 2, 2026, the Company announced positive results from the ALIGN-ACS Heart Attack Detection pilot study during a presentation at TCT 2026 in San Diego, CA. HeartBeam’s 3D ECG technology was shown to be as accurate as the standard 12-Lead ECG. The device demonstrated higher specificity than standard 12-lead ECG (81.8% vs. 71.4%), with comparable sensitivity. HeartBeam ECGs were interpreted more consistently across cardiologists than standard 12-lead ECGs. 100% of patients successfully recorded their own ECGs with HeartBeam device, supporting potential use outside traditional clinical settings.
The ALIGN-ACS pilot study enrolled 132 adults at the emergency departments of two major cardiology centers in Belgrade, Serbia, to evaluate the diagnostic accuracy of the HeartBeam System compared with a standard 12-lead ECG in assessing acute coronary syndrome (ACS), which includes myocardial infarction (MI, or heart attack). Eight cardiologists, blinded to each patient’s diagnosis, independently interpreted both the HeartBeam and standard 12-lead ECG recordings. Their interpretations were compared with each patient’s final diagnosis, as determined by an independent panel of three cardiologists who reviewed all available clinical information.
Nasdaq Deficiency Letter
On June 30, 2026, the Company received a deficiency letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC notifying the Company that the closing bid price of its common stock had fallen below the $1.00 per share minimum bid price requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2). The notification has no immediate effect on the listing or trading of the Company’s common stock. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a compliance period of 180 calendar days, or until December 28, 2026, to regain compliance. The Company intends to monitor the closing bid price of its common stock and evaluate available options to regain compliance within the prescribed timeframe. If the Company does not regain compliance within the initial 180-day period, the Company may be eligible for an additional compliance period or the Company’s common stock may be subject to delisting, which would materially adversely affect the liquidity of the Company’s common stock and its ability to raise capital.
Entry into ATM Sales Agreement
On August 14, 2026, the Company entered into an At-The-Market Equity Offering Sales Agreement (the “Sales Agreement”) with Titan Partners Securities LLC, as sales agent, pursuant to which the Company may sell, from time to time, an aggregate of up to $25,000,000 of its common stock, par value $0.0001 per share (the “Shares”).
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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-six (26) issued patents worldwide, consisting of eighteen (18) 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 nine (9) additional pending patent applications, including two (2) applications that have been allowed and are awaiting issuance. 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, including six (6) applications that have been allowed and are awaiting grant.
The issued patents are expected to expire between April 11, 2036, and May 30, 2043. The pending applications, regardless of publication status, are projected to expire between April 11, 2036, and February 20, 2045.
Over the course of 2025 and 2026, a total of fifteen (15) patent applications have been allowed and we have been granted a total of nine (9) new patents, with eight (8) additional patents pending issuance, relating to its 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 July 2026, HeartBeam was awarded a new U.S. patent, expanding acoustic sensing and fluid monitoring capabilities of our cable-free ECG device. The patent covers the integration of acoustic sensing and thoracic impedance measurement into the existing ECG hardware platform, supporting future applications in structural heart disease and heart failure monitoring. Heart failure affects nearly 6.7 million adults in the U.S., costs an estimated $30,000 per patient annually, and is one of the leading causes of hospitalization. One of the biggest challenges is that patients accumulate fluid over days before symptoms become severe enough to prompt a hospital visit. Earlier detection of fluid buildup could enable physicians to intervene with diuretics or medication adjustments before hospitalization becomes necessary, improving patient outcomes while reducing healthcare costs.
In addition, HeartBeam continues to expand its intellectual property portfolio and filed two (2) non-provisional patent applications, three (3) provisional patent applications (two of which have since been abandoned), and three (3) continuing applications throughout 2025, further strengthening the protection of its proprietary technologies.
The Company’s issued and pending U.S. patent claims are directed to compact electrocardiogram (ECG) systems for remote detection and/or diagnosis of acute myocardial infarction (“AMI”). Outside of the U.S., the pending applications in the European Union, Canada (“CA”), Australia (“AU”), Japan (“JP”), South Korea (“KR”), and China (“CN”) generally correspond to the Company’s U.S. filings.
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Results of Operations
The following table summarizes our results of operations for the periods presented on our statement of operations data.
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Three months ended |
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Nine months ended |
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2026 |
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2025 |
|
|
Change |
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|
% |
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|
2026 |
|
|
2025 |
|
|
Change |
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|
% |
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||||||||
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|
(In thousands, except percentages) |
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|||||||||||||||||||||||||||||
Operating expenses: |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Selling, general and administrative |
|
$ |
1,339 |
|
|
$ |
2,012 |
|
|
$ |
(673 |
) |
|
|
(33 |
)% |
|
$ |
6,449 |
|
|
$ |
5,733 |
|
|
$ |
716 |
|
|
|
12 |
% |
Research and development |
|
|
2,118 |
|
|
|
3,278 |
|
|
|
(1,160 |
) |
|
|
(35 |
)% |
|
|
6,816 |
|
|
|
10,096 |
|
|
|
(3,280 |
) |
|
|
(32 |
)% |
Total operating expenses |
|
|
3,457 |
|
|
|
5,290 |
|
|
|
(1,833 |
) |
|
|
(35 |
)% |
|
|
13,265 |
|
|
|
15,829 |
|
|
|
(2,564 |
) |
|
|
(16 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Loss from operations |
|
|
(3,457 |
) |
|
|
(5,290 |
) |
|
|
1,833 |
|
|
|
(35 |
)% |
|
|
(13,265 |
) |
|
|
(15,829 |
) |
|
|
2,564 |
|
|
|
(16 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Interest income |
|
|
63 |
|
|
|
36 |
|
|
|
27 |
|
|
|
75 |
% |
|
|
135 |
|
|
|
117 |
|
|
|
18 |
|
|
|
15 |
% |
Other income, net |
|
|
384 |
|
|
|
(1 |
) |
|
|
385 |
|
|
|
(38,500 |
)% |
|
|
381 |
|
|
|
(1 |
) |
|
|
382 |
|
|
|
(38,200 |
)% |
Total other income |
|
|
447 |
|
|
|
35 |
|
|
|
412 |
|
|
|
1,177 |
% |
|
|
516 |
|
|
|
116 |
|
|
|
400 |
|
|
|
345 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Income tax provision |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(3,010 |
) |
|
$ |
(5,255 |
) |
|
$ |
2,245 |
|
|
|
(43 |
)% |
|
$ |
(12,749 |
) |
|
$ |
(15,713 |
) |
|
$ |
2,964 |
|
|
|
(19 |
)% |
Summary of Statements of Operations for the three and nine months ended September 30, 2026 compared with the three and nine months ended September 30, 2025:
Selling, General and administrative (“SG&A”) expenses decreased by approximately $0.7 million or 33% during the three months ended September 30, 2026 as compared to the three months ended September 30, 2025. The decrease in SG&A expense of $0.7 million is primarily related to non-cash stock-based compensation expense amounting to $0.4 million and a reduction in employee costs of $0.3 million driven by lower headcount period over period.
Selling, General and administrative (“SG&A”) expenses increased by approximately $0.7 million or 12% during the nine months ended September 30, 2026 as compared to the nine months ended September 30, 2025. The increase in SG&A expense of $0.7 million is primarily related to non-cash stock-based compensation expense amounting to $0.8 million, partially offset by an overall reduction in SG&A, as the Company reduced its cost profile compared to the prior year.
Research and development expenses (“R&D”) expenses decreased by approximately $1.2 million or 35% during the three months ended September 30, 2026, as compared to the three months ended September 30, 2025. The decrease in R&D expense is primarily related to (1) the completion of product development and consulting costs related to the HeartBeam System and a prototype patch device of $0.8 million, (2) completion of enrollment in the pilot study ALIGN-ACS of $0.3 million, and (3) decrease of headcount related costs of $0.1 million.
Research and development expenses (“R&D”) expenses decreased by approximately $3.3 million or 32% during the nine months ended September 30, 2026, as compared to the nine months ended September 30, 2025. The decrease in R&D expense is primarily related to (1) the completion of product development and consulting costs related to the HeartBeam System of $2.0 million, (2) a decrease in headcount related costs of $0.7 million, and (3) a decrease in non-cash stock-based compensation expense of $0.6 million.
Other income primarily reflects net proceeds received under a settlement agreement.
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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 and marketing for the limited launch and commercial strategy of our HeartBeam System.
As of September 30, 2026, we had approximately $6.1 million in cash and cash equivalents, an increase of $1.7 million from $4.4 million as of December 31, 2025. During the nine months ended September 30, 2026, we raised gross proceeds of approximately $13.1 million from the combination of (1) an underwritten public offering that closed in April 2026, (2) the exercise of the over-allotment option associated with the public offering, and (3) shares issued under the ATM. 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.
As of September 30, 2025, we had approximately $1.9 million in cash and cash equivalents, a decrease of $0.5 million from $2.4 million as of December 31, 2024.
Our cash balance is as follows (in thousands):
|
|
September 30, |
|
|
December 31, |
|
||
Cash and cash equivalents |
|
$ |
6,065 |
|
|
$ |
4,380 |
|
Cash flows for the nine months ended September 30, 2026 and 2025 (in thousands):
|
|
Nine months ended September 30, |
|
|||||
|
|
2026 |
|
|
2025 |
|
||
Net cash used in operating activities |
|
$ |
(9,540 |
) |
|
$ |
(11,082 |
) |
Net cash used in investing activities |
|
|
(564 |
) |
|
|
(184 |
) |
Net cash provided by financing activities |
|
|
11,790 |
|
|
|
10,745 |
|
Operating Activities:
Net cash used in our operating activities of $9.5 million during the nine months ended September 30, 2026 is primarily due to our net loss of $12.7 million less $5.0 million in non-cash expenses and $1.9 million of net changes in operating assets and liabilities.
Net cash used in our operating activities of $11.1 million during the nine months ended September 30, 2025 is primarily due to our net loss of $15.7 million less $3.7 million in non-cash expenses and $0.9 million of net changes in operating assets and liabilities.
Investing Activities:
Net cash used in investing activities of $0.6 million during the nine months ended September 30, 2026, is from the purchase of property and equipment.
Net cash used in investing activities during the nine months ended September 30, 2025, of $0.2 million is from the purchase of property and equipment.
Financing Activities
Net cash provided by financing activities of $11.8 million during the nine months ended September 30, 2026, is primarily from $10.3 million from the sale of common stock and warrants, net of issuance costs, and $1.5 million from the sale of common stock under the ATM, net of issuance costs.
During the nine months ended September 30, 2025, net cash provided by financing activities of $10.7 million is primarily from net proceeds from sale of common stock and warrants, net of issuance costs.
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Table of Contents
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.
As a smaller reporting company, we are not required to provide the information required by this Item. 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 Principal 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 Principal 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 September 30, 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 Rules 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during our fiscal quarter ended September 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II-OTHER INFORMATION
Item 1. Legal Proceedings.
There are no actions, suits, proceedings, inquiries or investigations 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, threatened against or affecting our Company, our common stock, or 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.
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Item 6. Exhibits
The exhibit index set forth below is incorporated by reference in response to this Item 6.
Exhibit Number |
|
Description of Exhibit |
3.1 |
|
Articles of Incorporation filed with the State of Delaware on June 11, 2015 (incorporated by reference to Exhibit 3.1 to our registration statement on Form S-1 filed September 7, 2021) |
3.2 |
|
Bylaws (incorporated by reference to Exhibit 3.2 to our registration statement on Form S-1 filed September 9, 2021) |
3.3 |
|
Amendment to Articles of Incorporation filed with the State of Delaware on September 27, 2021 (incorporated by reference to Exhibit 3.3 to our registration statement on Form S-1 filed October 4, 2021) |
3.4 |
|
Second Amended and Restated Articles of Incorporation dated November 15, 2022 (incorporated by reference to Exhibit 3.14 to our current report on Form 8-K filed November 17, 2022) |
10.1 |
|
Sales Agreement, dated August 14, 2026 (incorporated by reference to Exhibit 1.1 to our current report on Form 8-K filed August 14, 2026) |
31.1* |
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 * |
31.2* |
|
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 * |
32.1** |
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 ** |
32.2** |
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 ** |
101.INS |
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Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document+ |
101.SCH |
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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. |
† |
|
Certain identified information has been excluded from the exhibits marked with this symbol because it is both not material and is the type of information that the Registrant treats as private or confidential. |
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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.
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HEARTBEAM, INC. |
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By: |
/s/ Branislav Vajdic |
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Name: |
Branislav Vajdic |
|
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Title: |
President |
Dated: November 12, 2026 |
|
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(Principal Executive Officer) |
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By: |
/s/ Timothy Cruickshank |
|
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Name: |
Timothy Cruickshank |
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Title: |
Chief Financial Officer |
Dated: November 12, 2026 |
|
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(Principal Financial and Accounting Officer) |
22