08/13/2026 | Press release | Distributed by Public on 08/13/2026 14:02
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.
The following management's discussion and analysis is intended as a review of significant factors affecting our financial condition and results of operations for the periods indicated. The discussion should be read in conjunction with our condensed unaudited financial statements and the notes presented herein included in this Form 10-Q and the audited financial statements and the other information set forth in the 2025 Form 10-K. When used, the words "believe," "plan," "intend," "anticipate," "target," "estimate," "expect" and the like, and/or future tense or conditional constructions ("will," "may," "could," "should," etc.), or similar expressions, identify certain of these forward-looking statements. In addition to historical information, the following Management's Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements that involve risks and uncertainties including, but not limited to, those set forth below under "Risk Factors" and elsewhere herein, and those identified under Part I, Item 1A of our 2025 Form 10-K. Our actual results could differ significantly from those anticipated in these forward-looking statements as a result of certain factors discussed herein and any other periodic reports filed and to be filed with the Securities and Exchange Commission.
Overview
Company Overview
We are a medical technology company focused on transforming cardiac care through the power of personalized insights. Our aim is to deliver innovative, higher resolution ambulatory cardiac monitoring solutions that can be used by patients anywhere to enable the detection and monitoring of cardiac disease outside of a healthcare facility. Our ability to develop higher resolution Electrocardiogram ("ECG") solutions is achieved through the development of our proprietary and patented technology platform that allows us to collect the heart's electrical activity from three dimensions and synthesize a 12-Lead ("12L") ECG from these signals.
We believe our products ("Products" or "Product") and services will benefit many stakeholders, including patients, healthcare providers, and healthcare payers, and will also address the rapidly growing field of ambulatory cardiac monitoring. As part of our long-term vision, we believe that we are uniquely positioned to play a central role in high-risk Coronary Artery Disease ("CAD") monitoring, given positive, proof-of-concept data from the initial feasibility studies that demonstrated comparable performance of the HeartBeam System and the standard 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 we have created the most info-rich ambulatory ECG signal available, led by our patented 3D signal technology. It is one platform, with many form factors. 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 U.S. Food and Drug Administration ("FDA") cleared cable-free, ambulatory synthesized 12-lead ECG that captures the heart's electrical signals from three dimensions for high-fidelity data collection and advanced diagnostics for arrhythmia assessment. The HeartBeam System is comprised of a credit card sized 3D ECG recording device, a patient application, a physician portal, and powerful cloud-based algorithms. Unlike any single-lead or 6-lead consumer device, HeartBeam's patented cable-free, 3D technology captures the heart's electrical signals in three non-coplanar dimensions and synthesizes them into a familiar 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 promptly reviewed by an on-demand, board-certified cardiologist for arrhythmia assessment.
HeartBeam's credit card sized 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and the additional 12-Lead ECG synthesis software received FDA clearance for arrhythmia assessment in December 2025. During the six months ended June 30, 2025 and June 30, 2026, the HeartBeam System did not generate any revenue.
Future form factors include the 12-Lead Patch and a ruggedized, industrial form factor for rural and international usage.
Strategic Focus
In June 2026, the Company announced a strategic shift in order to accelerate the global adoption of its ambulatory ECG signal platform.
The Company is focused on advancing several key initiatives as part of this growth strategy:
As of June 30, 2026, we had 16 employees. In June 2026, the Company announced that Rob Eno transitioned from the role of Chief Executive Officer to a consulting role.
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. 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.
Recent Developments
Pilot Study of First On-Demand 12-Lead ECG Patch to Detect Ischemia Outside the Clinic
On May 11, 2026, the Company announced the initiation of a pilot study evaluating its novel on-demand 12-lead ECG patch in patients with suspected coronary artery disease. The study is being conducted at two leading hospitals in Belgrade, Serbia. The initiation of the pilot study represents a significant step in the development of the HeartBeam patch which has the potential to disrupt the long-term continuous monitor and mobile cardiac telemetry (MCT) markets.
The pilot study will enroll approximately 50 patients with a high risk of coronary artery disease whose resting ECGs show no evidence of ischemia. Each participant will undergo exercise stress testing, a standard diagnostic procedure used to identify ischemic changes. Immediately following exercise, patients will activate the HeartBeam patch to record HeartBeam's 3D 3-lead signals , which will be compared for diagnostic accuracy with a standard 12-lead ECG recorded at the same time. The results will help inform the Company's broader regulatory strategy for the HeartBeam patch.
Robert P. Eno Departure
On June 18, 2026, the Company and Robert P. Eno mutually agreed to his departure as the Company's Chief Executive Officer, as a member of the Board of Directors, and as the Company's principal executive officer, effective as of June 30, 2026, in connection with a strategic reorganization within the Company.
Mr. Eno's decision to depart is not the result of any dispute or disagreement with the Company on any matter relating to the Company's operations, policies or practices. In connection with Mr. Eno's departure, he has entered into a consulting agreement with the Company whereby Mr. Eno will provide support services to the Company in an advisory capacity. Any payment of the severance amounts pursuant to the terms of Mr. Eno's Employment Agreement dated as of January 17, 2023 (the "Employment Agreement") was subject to Mr. Eno's execution of a release of claims satisfactory to the Company.
Until a new Chief Executive Officer is identified, the Company will strategically align its operations around focused implementation teams led by Branislav Vajdic, Ph.D., Founder and President, and Rich Ferrari, Executive Chairman of the Board. Dr. Vajdic, will also serve as the Company's principal executive officer, effective July 1, 2026.
Mark Strome Resignation
On June 18, 2026, Mark Strome notified the Company of his resignation from the Board of Directors and all committees thereof, effective immediately. Mr. Strome's resignation was not due to any dispute or disagreement with the Company on any matter relating to the Company's operations, policies, or practices.
Compensatory Arrangements of Named Executive Officers
On June 15, 2026, the Compensation Committee of the Board of Directors (the "Board") of HeartBeam, Inc. (the "Company") approved certain compensatory arrangements for Branislav Vajdic, the Company's President, Founder and Director, including a performance-based restricted stock unit ("PRSU") award and a transaction bonus agreement (the "Transaction Bonus Agreement"), each as described below.
PRSU
On June 15, 2026, the Board approved a performance-based restricted stock unit award under the Company's 2022 Equity Incentive Plan to Dr. Vajdic covering 2,800,000 restricted stock units. The performance-based restricted stock units are eligible to vest only if and to the extent that specified performance-based conditions and service-based conditions are satisfied, or the requirements for accelerated vesting are satisfied.
The performance-based conditions relate to specified operational, software, product-development and clinical study milestones during the period beginning on the grant date and ending on the earlier of the one-year anniversary of the grant date and the day before the effective date of the first Change in Control to occur after the grant date. The service-based conditions are satisfied as to one-third of the performance-based restricted stock units on each of the first three anniversaries of the grant date, subject to Dr. Vajdic's continued service through the applicable date, provided that if a Change in Control occurs on or before the three-year anniversary of the grant date, then the service-based condition will be satisfied immediately prior to such Change in Control, subject to Dr. Vajdic's continued service through such time.
The performance-based restricted stock unit award also provides for accelerated vesting upon a qualifying termination before the three-year anniversary of the grant date, to the extent applicable performance milestones were timely achieved before such qualifying termination and subject to Dr. Vajdic's satisfaction of the applicable release condition.
Transaction Bonus Agreement
Subject to Dr. Vajdic's continued employment with the Company through immediately prior to a Qualifying Change in Control (as defined in the Transaction Bonus Agreement), the transaction bonus will be determined based on achievement of specified market capitalization and per-share price thresholds. If the minimum threshold is not achieved, no transaction bonus will be payable.
Any transaction bonus that becomes payable will generally be paid in the same form or forms and in the same proportions of consideration paid to the Company's stockholders in the Qualifying Change in Control, except that the Board may determine to pay all or a portion of the transaction bonus in cash. Any amount payable at closing will be paid no later than 30 days after the closing, and any amount attributable to post-closing payments will be paid if and when such amounts are paid to the Company's stockholders, subject to the terms of the Transaction Bonus Agreement.
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 29, 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.
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 seventeen (17) issued patents in the United States and eight (8) issued patents outside of the United States, including one (1) European patent granted with unitary effect under the Unitary Patent system.
In the United States, the Company also has eleven (11) additional pending patent applications, 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 three (3) applications that have been allowed and are awaiting grant.
The issued patents are expected to expire between April 11, 2036, and April 21, 2042. The pending applications, regardless of publication status, are projected to expire between April 11, 2036, and February 20, 2045.
Over the course of 2025 and into early 2026, the Company was granted a total of eight (8) new patents 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 (one of which has been abandoned) and three (3) continuing patent 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.
Results of Operations
The following table summarizes our results of operations for the periods presented on our statement of operations data.
|
For the three months ended June 30, |
For the six months ended June 30, |
|||||||||||||||||||||||||||||||
|
2026 |
2025 |
Change |
% |
2026 |
2025 |
Change |
% |
|||||||||||||||||||||||||
|
(In thousands, except percentages) |
||||||||||||||||||||||||||||||||
|
Operating expenses: |
||||||||||||||||||||||||||||||||
|
Selling, general and administrative |
$ |
2,764 |
$ |
1,711 |
$ |
1,053 |
62 |
% |
$ |
5,110 |
$ |
3,720 |
$ |
1,390 |
37 |
% |
||||||||||||||||
|
Research and development |
2,328 |
3,326 |
(998 |
) |
(30 |
)% |
4,698 |
6,818 |
(2,120 |
) |
(31 |
)% |
||||||||||||||||||||
|
Total operating expenses |
5,092 |
5,037 |
55 |
1 |
% |
9,808 |
10,538 |
(730 |
) |
(7 |
)% |
|||||||||||||||||||||
|
Loss from operations |
(5,092 |
) |
(5,037 |
) |
(55 |
) |
1 |
% |
(9,808 |
) |
(10,538 |
) |
730 |
(7 |
)% |
|||||||||||||||||
|
Interest income |
53 |
63 |
(10 |
) |
(16 |
)% |
69 |
80 |
(11 |
) |
(14 |
)% |
||||||||||||||||||||
|
Total other income |
53 |
63 |
(10 |
) |
(16 |
)% |
69 |
80 |
(11 |
) |
(14 |
)% |
||||||||||||||||||||
|
Income tax provision |
- |
- |
- |
- |
- |
- |
- |
- |
||||||||||||||||||||||||
|
Net loss |
$ |
(5,039 |
) |
$ |
(4,974 |
) |
$ |
(65 |
) |
1 |
% |
$ |
(9,739 |
) |
$ |
(10,458 |
) |
$ |
719 |
(7 |
)% |
|||||||||||
Summary of Statements of Operations for the three and six months ended June 30, 2026 compared with the three and six months ended June 30, 2025:
Selling, General and administrative ("SG&A") expenses increased by approximately $1.1 million or 62% during the three months ended June 30, 2026 as compared to the three months ended June 30, 2025. The increase in SG&A expense of $0.7 million is primarily related to non-cash stock-based compensation expense amounting to $0.6 million driven by acceleration of awards granted to former CEO post his termination effective June 30, 2026, $0.3 million related to severance accrual payable to former CEO, and $0.1 million related to sales team expenses related to our commercialization efforts.
Selling, General and administrative ("SG&A") expenses increased by approximately $1.4 million or 37% during the six months ended June 30, 2026 as compared to the six months ended June 30, 2025. The increase in SG&A expense of $1.2 million is primarily related to non-cash stock-based compensation expense amounting to $0.6 million driven by acceleration of awards granted to former CEO post his termination effective June 30, 2026, $0.3 million related to severance accrual payable to former CEO, and $0.2 million related to sales team expenses related to our commercialization efforts.
The increase related to non-cash stock-based compensation expense of $0.6 million driven by award acceleration and the severance accrual payable to the former CEO of $0.3 million during the three and six months ended June 30, 2026 are one time in nature and are therefore not expected to continue beyond June 30, 2026.
Research and development expenses ("R&D") expenses decreased by approximately $1.0 million or 30% during the three months ended June 30, 2026, as compared to the three months ended June 30, 2025. The decrease in R&D expense is primarily related to a decrease in product development and consulting expenses of $0.7 million related to the development of the HeartBeam System, decrease of headcount related costs of $0.1 million during 2025 and decrease of non-cash stock-based compensation expense amounting to $0.2 million resulting from the full vesting of milestone awards as of December 31, 2025.
Research and development expenses ("R&D") expenses decreased by approximately $2.1 million or 31% during the six months ended June 30, 2026, as compared to the six months ended June 30, 2025. The decrease in R&D expense is primarily related to a decrease in product development expenses of $1.2 million related to the development of the HeartBeam System, decrease of headcount related costs of $0.4 million during 2025 and decrease of non-cash stock-based compensation expense amounting to $0.5 million resulting from the full vesting of milestone awards as of December 31, 2025.
Other income is related to interest income. The decrease is primarily driven by cash used in operations.
Liquidity and Capital Resources
Our cash requirements are, and will continue to be, dependent upon a variety of factors. We expect to continue devoting capital resources to R&D for the development of software and hardware products and to sales & marketing for the limited launch and commercial strategy of our HeartBeam system.
As of June 30, 2026, we had approximately $8.7 million in cash and cash equivalents, an increase of $4.3 million from $4.4 million as of December 31, 2025. During the six months ended June 30, 2026, we raised gross proceeds of approximately $11.5 million from an underwritten public offering that closed in April 2026, including the exercise of the overallotment option. Based on our current business plan assumptions and expected cash burn rate, the Company believes that the existing cash is insufficient to fund operations for the next twelve months following the issuance of these financial statements. These factors raise substantial doubt regarding the Company's ability to continue as a going concern.
In the prior corresponding period ending June 30, 2025, we had approximately $3.3 million in cash and cash equivalents, an increase of $0.9 million from $2.4 million as of December 31, 2024. In addition, the Company held short-term investments of $1.8 million as treasury securities at the balance sheet date. When combined with cash and cash equivalents of $3.3 million, the balance for the Company as of June 30, 2025 was $5.1 million.
Our cash balance is as follows (in thousands):
|
June 30, |
December 31, |
|||||||
|
Cash and cash equivalents |
$ |
8,722 |
$ |
4,380 |
||||
Cash flows for the six months ended June 30, 2026 and 2025 (in thousands):
|
Six months ended June 30, |
||||||||
|
2026 |
2025 |
|||||||
|
Net cash used in operating activities |
$ |
(6,952 |
) |
$ |
(7,922 |
) |
||
|
Net cash used in investing activities |
(495 |
) |
(1,899 |
) |
||||
|
Net cash provided by financing activities |
11,790 |
10,700 |
||||||
Operating Activities:
Net cash used in our operating activities of $7.0 million during the six months ended June 30, 2026 is primarily due to our net loss of $9.7 million less $3.5 million in non-cash expenses and $0.8 million of net changes in operating assets and liabilities.
Net cash used in our operating activities of $7.9 million during the six months ended June 30, 2025, is primarily due to our net loss of $10.4 million less $2.3 million in non-cash expenses and $0.2 million of net changes in operating assets and liabilities.
Investing Activities:
Net cash used in investing activities of $0.5 million during the six months ended June 30, 2026, is primarily from the purchase of property and equipment.
Net cash used in investing activities of $1.9 million during the six months ended June 30, 2025, is primarily from $0.1 million from the purchase of property and equipment, $3.8 million from the gross purchase of short-term investments and offset by the maturities of short-term investments of $2.0 million.
Financing Activities
Net cash provided by financing activities of $11.8 million during the six months ended June 30, 2026, is primarily from $10.3 million from the sale of common stock, net of issuance costs, and $1.5 million from sale of common stock under ATM, net of issuance costs.
Net cash provided by financing activities of $10.7 million during the six months ended June 30, 2025, is primarily from net proceeds from the sale of common stock, net of issuance costs.
Critical Accounting Estimates
There have been no material changes to our critical accounting estimates from the information provided in Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations," included in our 2025 Annual Report.