HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful personalized insights, today reported its financial and operational results for the third quarter ended September 30, 2026.

Third Quarter & Subsequent 2026 Operational Highlights

In September 2026, the Company sharpened its strategy and directed the majority of its financial and personnel resources to heart attack assessment, which it views as its largest value-creation opportunity. Since then, HeartBeam has received FDA Breakthrough Device Designation, been accepted into FDA’s TAP program, completed enrollment in HEADSTART-ACS, its largest heart attack assessment study to date, and reported positive pilot results from ALIGN-ACS at TCT 2026. The Company now plans to finalize the U.S. pivotal study design in the fourth quarter of 2026 and begin patient enrollment in the first quarter of 2027.

Heart Attack Assessment: Strategic Focus

  • In September 2026, the Company announced it is redirecting the majority of its resources to heart attack (myocardial infarction, or MI) assessment.

  • More than 20 million U.S. adults are at elevated risk of a heart attack, a population the Company estimates is approximately four times larger than the arrhythmia market.

  • The Company estimates the MI opportunity at approximately $15 billion, within a broader cardiac platform opportunity exceeding $40 billion.

Regulatory Progress

  • In October 2026, received FDA Breakthrough Device Designation for the HeartBeam System as a tool for assessing potential heart attacks at home.

  • FDA granted the Breakthrough designation within 30 days of the Company’s request, ahead of the agency’s 60-day statutory review period.

  • In October 2026, the HeartBeam System was accepted into FDA’s Total Product Life Cycle Advisory Program (TAP), which provides dedicated FDA advisors and early engagement with payers, including the Centers for Medicare & Medicaid Services.

  • In October 2026, the Company reached alignment with the FDA on a 510(k) pathway for the heart attack assessment indication.

  • The Company plans to initiate its U.S. pivotal study in the first quarter of 2027 leveraging results from the ALIGN-ACS pilot study to finalize the design of the study in the fourth quarter of 2026.

  • The U.S. pivotal study is intended to support a future FDA submission to expand the HeartBeam System’s indication beyond arrhythmia assessment to include heart attack assessment.

Positive Pilot Study Results Presented at TCT 2026

  • ALIGN-ACS pilot study results were presented by Graham Nichol, MD, MPH, FRCP(C), of the University of Washington, at TCT 2026 in San Diego.

  • The study enrolled 132 adults at the emergency departments of two major cardiology centers in Belgrade, Serbia, and evaluated the diagnostic accuracy of the HeartBeam System compared with a standard 12-lead ECG in assessing acute coronary syndrome (ACS).

  • Eight cardiologists, blinded to each patient’s diagnosis, independently interpreted both HeartBeam and standard 12-lead ECG recordings. Interpretations were compared with each patient’s final diagnosis as determined by an independent panel of three cardiologists.

Key findings:

  • Higher specificity, comparable sensitivity. HeartBeam showed higher specificity than standard 12-lead ECG (81.8% vs. 71.4%) with comparable sensitivity (60.2% vs. 63.0%), pointing to its potential as a rule-in diagnostic aid.

  • Comparable sensitivity in STEMI assessment. For ST-elevation myocardial infarction, the most time-sensitive form of heart attack, sensitivity was 82.9% for HeartBeam vs. 83.8% for standard 12-lead ECG.

  • More consistent interpretation. Cardiologists agreed more often when reading HeartBeam recordings (Fleiss’ kappa 0.73 vs. 0.54 for standard 12-lead ECG).

  • Patient ease of use. 100% of patients recorded their own HeartBeam ECG under clinical supervision with no prior training, supporting potential use outside traditional clinical settings.

Growing Body of Clinical Evidence

  • In October 2026, completed enrollment ahead of schedule in HEADSTART-ACS, the largest heart attack assessment study to date using HeartBeam technology.

  • The study enrolled 486 emergency department patients with chest pain at the National Cardiovascular Center Harapan Kita in Jakarta, Indonesia.

  • Indonesia, the world’s fourth most populous country, represents a strategically significant market of 288 million people.

  • Together with ALIGN-ACS, the Company now has clinical experience with more than 600 patients in heart attack assessment.

  • In October 2026, joined the EU-co-funded EXIT-CVD research consortium as a contributing partner, alongside Philips, Medtronic, GE HealthCare and other global healthcare organizations.

  • HeartBeam will lead the HEART-CHECK study, one of EXIT-CVD’s 22 clinical studies, evaluating the HeartBeam System for early detection and triage of cardiac events in high-risk patients recently discharged after an acute coronary syndrome.

Other Operational Highlights:

  • In July 2026, HeartBeam was awarded a new U.S. patent covering the integration of acoustic sensing and thoracic impedance measurement into the Company’s existing ECG hardware platform, supporting future applications in structural heart disease and heart failure monitoring. The Company’s patent portfolio includes 26 issued patents worldwide.

  • Cash and cash equivalents totaled $6.1 million as of September 30, 2026, compared to $4.4 million as of December 31, 2025. Net cash used in operating activities was $2.6 million for the third quarter of 2026, a 23% decrease compared to the second quarter of 2026 and an 18% decrease compared to the third quarter of 2025.

Management Commentary

“The third quarter marked a decisive turn for HeartBeam,” said Richard Ferrari, Executive Chairman. “We committed the majority of our resources to heart attack assessment, and the milestones have quickly followed. In just the last six weeks, we received FDA Breakthrough Device Designation, were accepted into FDA’s TAP program, and aligned with the FDA on a 510(k) submission pathway for a heart attack assessment indication. We also completed enrollment in HEADSTART-ACS ahead of schedule and presented positive results from the ALIGN-ACS pilot study at TCT showing higher specificity than the standard 12-lead ECG. With clinical experience in more than 600 patients and no new hardware required, we are focused on beginning our U.S. pivotal study in the first quarter of 2027.”

Branislav Vajdic, Ph.D., Founder and President of HeartBeam, added, “Today, a person with chest pain at home has no reliable way to know whether it is a heart attack, and that uncertainty results in delays and potentially worse outcomes. Our goal is to shorten the time between the first sign of symptoms and the decision to seek care, by giving patients and their physicians clinical-grade cardiac information when every minute matters. We believe HeartBeam can help close that gap for the millions of people at risk.”

Third Quarter 2026 Financial Results

Selling, general and administrative expenses for the third quarter of 2026 were $1.3 million, compared to $2.0 million for the third quarter of 2025, a decrease of 33%. The decrease in SG&A expense of $0.7 million is primarily related to a decrease in non-cash stock-based compensation expense of $0.4 million and a reduction in employee costs of $0.3 million driven by lower headcount period over period.

Research and development expenses for the third quarter of 2026 were $2.1 million, compared to $3.3 million for the third quarter of 2025, a decrease of 35%. The decrease in R&D expense is primarily related to the completion of product development and consulting costs related to the HeartBeam System and a prototype patch device of $0.8 million, completion of enrollment in the ALIGN-ACS pilot study of $0.3 million, and a decrease in headcount-related costs of $0.1 million.

Total operating expenses for the third quarter of 2026 were $3.5 million, compared to $5.3 million for the third quarter of 2025.

Net loss for the third quarter of 2026 was $3.0 million, or $(0.05) per basic and diluted share, compared to a net loss of $5.3 million, or $(0.15) per basic and diluted share, for the third quarter of 2025.

Net cash used in operating activities was $2.6 million for the third quarter of 2026, a 23% decrease compared to the second quarter of 2026 and an 18% decrease compared to the third quarter of 2025. Net cash used in operating activities was $9.5 million for the nine months ended September 30, 2026, compared to $11.1 million for the nine months ended September 30, 2025, a decrease of 14%.

Cash and cash equivalents totaled $6.1 million as of September 30, 2026, compared to $4.4 million as of December 31, 2025. In August 2026, the Company entered into an at-the-market sales agreement (the “ATM”) with Titan Partners Securities LLC, as sales agent, pursuant to which the Company may sell, from time to time, shares of its common stock, par value $0.0001 per share, having an aggregate offering price of up to $25.0 million. In the fourth quarter of 2026 through the date of this release, the Company raised net proceeds of approximately $4.0 million. Giving effect to these net proceeds, the Company’s pro forma cash and cash equivalents as of September 30, 2026, would have been approximately $10.1 million.

Financial Outlook

  • Third quarter 2026 operating cash outflow was lower than in the second quarter of 2026 as a result of the Company’s reduced cost structure and the capital efficiency created by the focused path to heart attack assessment.

  • As outlined previously, the baseline fourth quarter 2026 operating cash outflow is expected to be below $2.5 million; accelerated U.S. pivotal study timing would add to fourth quarter spending.

  • Full year 2026 net operating cash outflow is now expected to be between $12.0 million and $12.5 million, a further reduction from the Company’s previous guidance.

  • The Company expects its cash runway to extend further into 2027, aligned with the achievement of key milestones.

Third Quarter 2026 Results Conference Call

HeartBeam Executive Chairman Richard Ferrari, Founder and President Branislav Vajdic, Ph.D., and Chief Financial Officer Timothy Cruickshank will host the conference call, followed by a question-and-answer period. The conference call will be accompanied by a presentation, which can be viewed during the webcast or accessed following the call via the investor relations section of the Company’s website here.

To access the call, please use the following information:

Date:

Thursday, November 12, 2026

Time:

4:30 p.m. Eastern time (1:30 p.m. Pacific time)

Dial-in:

1-877-704-4453

International Dial-in:

1-201-389-0920

Conference Code:

13763268

Webcast:

https://viavid.webcasts.com/starthere.jsp?ei=1779198&tp_key=0e699c3be5

A telephone replay will be available approximately three hours after the call and will run through November 26, 2026, by dialing 1-844-512-2921 from the U.S. and Canada, or 1-412-317-6671 from international locations, and entering replay pin number: 13763268. The replay can also be viewed through the webcast link above and the presentation utilized during the call will be available in the Company’s investor relations section here.

About HeartBeam, Inc.

HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming the detection and monitoring of critical cardiac conditions. The Company has developed the first-ever cable-free device capable of collecting ECG signals in 3D, from three non-coplanar directions, and synthesizing the signals into a 12-lead ECG. 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. HeartBeam’s 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024, and its 12-lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 2025.1 The technology is currently being studied for heart attack assessment and is considered investigational in that indication. The Company holds over 25 issued patents worldwide related to technology enablement. For additional information, visit HeartBeam.com.

Forward-Looking Statements

All statements in this release that are not based on historical fact are “forward-looking statements.” While management has based any forward-looking statements included in this release on its current expectations, the information on which such expectations were based may change. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our Forms 10-K, 10-Q and other reports filed with the SEC and available at www.sec.gov. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

1Cleared Indications for Use

The HeartBeam System with 12-Lead ECG synthesis software is FDA cleared for arrhythmia assessment only. The technology’s use for heart attack assessment is investigational and not FDA cleared. For full details on the intended use of the HeartBeam technology, refer to the Company’s Cleared Indications for Use and full instructions at https://www.heartbeam.com/indications.

MKT-179 v0

 

HEARTBEAM, INC.

Condensed Balance Sheets (Unaudited)

(In thousands, except share data)
 

 

 

September 30,

2026

 

December 31,

2025

Assets

 

 

 

 

Current Assets:

 

 

 

 

Cash and cash equivalents

 

$

6,065

 

 

$

4,380

 

Prepaid expenses and other current assets

 

 

120

 

 

 

202

 

Inventory

 

 

114

 

 

 

103

 

Total Current Assets

 

 

6,299

 

 

 

4,685

 

 

 

 

 

 

Property and equipment, net

 

 

1,516

 

 

 

1,102

 

Other assets

 

 

57

 

 

 

56

 

Total Assets

 

$

7,872

 

 

$

5,843

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

Current Liabilities:

 

 

 

 

Accounts payable (includes related party $5 and $5, respectively)

 

$

267

 

 

$

1,053

 

Accrued expenses (includes related party $5 and $0, respectively)

 

 

1,091

 

 

 

2,187

 

Total Current Liabilities

 

 

1,358

 

 

 

3,240

 

 

 

 

 

 

Total Liabilities

 

 

1,358

 

 

 

3,240

 

 

 

 

 

 

Commitments and Contingencies (Note 8)

 

 

 

 

 

 

 

 

 

Stockholders’ Equity

 

 

 

 

Preferred stock – $0.0001 par value; 10,000,000 shares authorized; 0 shares outstanding at September 30, 2026 and December 31, 2025

 

$

—

 

 

$

—

 

Common stock – $0.0001 par value; 100,000,000 shares authorized; 57,513,001 and 40,117,404 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively

 

 

6

 

 

 

4

 

Additional paid in capital

 

 

96,545

 

 

 

79,887

 

Accumulated deficit

 

 

(90,037

)

 

 

(77,288

)

Total Stockholders’ Equity

 

 

6,514

 

 

 

2,603

 

 

 

 

 

 

Total Liabilities and Stockholders’ Equity

 

$

7,872

 

 

$

5,843

 
 

HEARTBEAM, INC.

Condensed Statements of Operations (Unaudited)

(In thousands, except share and per share data)
 

 

 

Three months ended

September 30,

 

Nine months ended

September 30,

 

 

 

2026

 

 

 

2025

 

 

 

2026

 

 

 

2025

 

Operating Expenses:

 

 

 

 

 

 

 

 

Selling, general and administrative

 

$

1,339

 

 

$

2,012

 

 

$

6,449

 

 

$

5,733

 

Research and development

 

 

2,118

 

 

 

3,278

 

 

 

6,816

 

 

 

10,096

 

Total operating expenses

 

 

3,457

 

 

 

5,290

 

 

 

13,265

 

 

 

15,829

 

Loss from operations

 

 

(3,457

)

 

 

(5,290

)

 

 

(13,265

)

 

 

(15,829

)

Other Income and (Expense)

 

 

 

 

 

 

 

 

Interest income

 

 

63

 

 

 

36

 

 

 

135

 

 

 

117

 

Other income, net

 

 

384

 

 

 

(1

)

 

 

381

 

 

 

(1

)

Total other income

 

 

447

 

 

 

35

 

 

 

516

 

 

 

116

 

Loss before provision for income taxes

 

 

(3,010

)

 

 

(5,255

)

 

 

(12,749

)

 

 

(15,713

)

Income tax provision

 

 

—

 

 

 

—

 

 

 

—

 

 

 

—

 

Net Loss

 

$

(3,010

)

 

$

(5,255

)

 

$

(12,749

)

 

$

(15,713

)

Net loss per share, basic and diluted

 

$

(0.05

)

 

$

(0.15

)

 

$

(0.25

)

 

$

(0.48

)

Weighted average common shares outstanding, basic and diluted

 

 

57,204,402

 

 

 

34,396,431

 

 

 

50,242,536

 

 

 

32,928,884

 
 

HEARTBEAM, INC.

Condensed Statements of Cash Flows (Unaudited)

(In thousands)
 

 

 

Nine months ended September 30,

 

 

 

2026

 

 

 

2025

 

Cash Flows From Operating Activities

 

 

 

 

Net loss

 

$

(12,749

)

 

$

(15,713

)

Adjustments to reconcile net loss to net cash used in operating activities

 

 

 

 

Depreciation

 

 

150

 

 

 

23

 

Stock based compensation expense

 

 

3,855

 

 

 

3,720

 

Stock issuance upon vesting of restricted stock units

 

 

915

 

 

 

—

 

Stock issuance for services

 

 

100

 

 

 

—

 

Changes in operating assets and liabilities:

 

 

 

 

Prepaid expenses and other current assets

 

 

82

 

 

 

123

 

Inventory

 

 

(11

)

 

 

—

 

Accounts payable and accrued expenses

 

 

(1,882

)

 

 

765

 

Net cash used in operating activities

 

 

(9,540

)

 

 

(11,082

)

 

 

 

 

 

Cash Flows From Investing Activities

 

 

 

 

Purchase of property and equipment

 

 

(564

)

 

 

(184

)

Purchase of short-term investments

 

 

—

 

 

 

3,760

 

Maturities of short-term investments

 

 

—

 

 

 

(3,760

)

Net cash used in investing activities

 

 

(564

)

 

 

(184

)

 

 

 

 

 

Cash Flows From Financing Activities

 

 

 

 

Proceeds from sale of equity, net of issuance costs

 

 

10,265

 

 

 

10,250

 

Proceeds from sale of equity under ATM, net of issuance costs

 

 

1,515

 

 

 

494

 

Proceeds from exercise of stock options

 

 

10

 

 

 

1

 

Net cash provided by financing activities

 

 

11,790

 

 

 

10,745

 

 

 

 

 

 

Net increase / (decrease) in cash and restricted cash

 

 

1,686

 

 

 

(521

)

Cash, cash equivalents and restricted cash – Beginning of period

 

 

4,436

 

 

 

2,433

 

 

 

 

 

 

Cash, cash equivalents and restricted cash – Ending of period

 

$

6,122

 

 

$

1,912

 

 

 

 

 

 

Reconciliation of cash, cash equivalents and restricted cash:

 

 

 

 

Cash and cash equivalents

 

$

6,065

 

 

$

1,856

 

Restricted cash (included in other assets)

 

 

57

 

 

 

56

 

Total cash, cash equivalents and restricted cash

 

$

6,122

 

 

$

1,912

 

 

 

 

 

 

Supplemental Disclosures of Cash Flow Information:

 

 

 

 

Purchase of property and equipment in accounts payable

 

$

—

 

 

$

83

 

Taxes paid

 

$

—

 

 

$

—

 

 

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