HeartBeam Reports Fourth Quarter and Full Year 2023 Financial Results
- HeartBeam making progress on clinical and regulatory milestones for AIMIGo™ 3D VECG system
- Anticipates FDA clearance for AIMIGo system by end of Q2 2024
- Recent patents on core VECG technology and AI program developments enhance intellectual property
- R&D and G&A expenses increased, leading to a net loss for Q4 and full year 2023
- Cash and cash equivalents at $16.2 million as of December 31, 2023, supporting upcoming milestones and extending cash runway into early 2025
- Net loss increased for Q4 and full year 2023 compared to the same periods in 2022
- R&D and G&A expenses rose for Q4 and full year 2023
- Cash used in operations was $12.1 million for the year ended December 31, 2023
Insights
The recent update from HeartBeam, Inc. on their AIMIGo™ 3D VECG system indicates significant strides in the company's clinical and regulatory journey. The enrollment of the first patients in the VALID-ECG pivotal study is a critical step towards validating the system's ability to synthesize a standard 12-lead ECG, which is a fundamental tool in diagnosing cardiac conditions. The anticipation of FDA clearance for the AIMIGo system by the end of Q2 2024 could mark a notable shift in patient-held cardiac diagnostic technology, potentially expanding the market for HeartBeam.
The acquisition of two new patents enhances the company's intellectual property portfolio, which can be important for maintaining competitive advantage in the medical technology landscape. Furthermore, the integration of artificial intelligence into the VECG technology could position HeartBeam at the forefront of personalized cardiac care, as AI has the potential to improve diagnostic accuracy and uncover subtle cardiac events that conventional methods may miss.
From a financial perspective, the reported cash and cash equivalents of $16.2 million provide HeartBeam with a runway into early 2025. This financial stability is essential for the company to continue its research and development efforts without immediate funding concerns. However, investors should monitor the company's cash burn rate and the outcomes of the ongoing clinical studies, as these will be pivotal in determining HeartBeam's future financial health and stock performance.
The financial results disclosed by HeartBeam, Inc. for Q4 and the full year of 2023 showcase an incremental increase in research and development expenses, which is indicative of the company's commitment to advancing its AIMIGo 3D VECG system. The increase in general and administrative expenses, although not substantial, reflects the company's growth trajectory and investment in its administrative capabilities to support its expanding operations.
While the net loss has widened from the previous year, this is not uncommon for companies in the growth phase, especially those in the medical technology sector investing heavily in innovation. The reported net cash used in operations aligns with the company's developmental activities. Investors should consider the potential for increased expenses as HeartBeam progresses through the regulatory approval process and prepares for a limited launch of AIMIGo by the end of 2024.
It is essential to evaluate the company's financial health in the context of its product pipeline and market potential. The successful commercialization of the AIMIGo system, pending regulatory approval, could lead to revenue generation and a positive shift in the company's financial trajectory. However, the inherent risks associated with the FDA approval process and the adoption of new medical technologies in the market must be weighed carefully.
The medical technology industry is rapidly evolving, with significant emphasis on portable and AI-enhanced diagnostic tools. HeartBeam's AIMIGo 3D VECG system represents a potential breakthrough in this space, offering personalized cardiac care through a patient-held device. The market for such innovative solutions is growing, driven by an aging population and an increased prevalence of cardiovascular diseases.
HeartBeam's strategic focus on expanding its intellectual property and integrating AI into its offerings could potentially disrupt the current market, which is dominated by traditional ECG devices. The company's ability to synthesize a 12-lead ECG from 3D VECG signals could differentiate it from competitors and provide a unique selling point that appeals to healthcare providers seeking more comprehensive and convenient diagnostic options for patients.
The presentations of their deep learning algorithm at upcoming electrophysiology conferences will be critical for HeartBeam to gain visibility and credibility within the medical community. Successful peer validation could lead to increased interest from potential partners and customers, thus influencing the company's market position and stock valuation in the long term.
- First Patients Enrolled in Pivotal Study Evaluating AIMIGo™ System for Synthesizing a 12-Lead ECG
- Ongoing Clinical and Regulatory Progress for the AIMIGo 3D VECG System
- Recently Received 2 New Patents for our Proprietary Technologies
- Management to Host Webcast and Conference Call Today At 4:30 p.m. ET
Fourth Quarter & Subsequent 2024 Operational Highlights
The company made steady progress toward key clinical and regulatory milestones on its AIMIGo™ 3D VECG system.
AIMIGo 510(k) submission:
- The 510(k) submission for the AIMIGo system is currently being reviewed by the FDA.
- The initial AIMIGo 510(k) submission is focused on the credit card-sized 3D VECG device, patient application, physician portal and wireless communication among the elements. This is the cornerstone submission for HeartBeam and will be the basis of future submissions.
- The company currently anticipates clearance by the end of Q2 2024.
12 Lead Synthesis Software submission:
- HeartBeam has held two pre-submission meetings with FDA on the planned second AIMIGo 510(k) submission, which is focused on the algorithms that synthesize a 12 lead ECG from the 3D VECG signals. This application will be submitted after the initial clearance of the 3D VECG System. The emphasis of the pre-submission meetings was on the performance goals of the VALID-ECG clinical study (Clinical Validation of the AIMIGo 12-Lead ECG Synthesis Software for Arrhythmia Detection) that will demonstrate the similarity between the synthesized 12L ECG and a standard 12L ECG.
- The company enrolled the first patients in the VALID-ECG pivotal study, with enrollment expected to be completed in Q2 2024.
- Prior to initiating the VALID-ECG study, HeartBeam completed an 80-patient pilot study using the same protocol as the VALID-ECG study.
Other highlights:
- Recently received two new patents on core vectorelectrocardiography (VECG) technology from the US Patent and Trademark Office, expanding intellectual property footprint to over 35 issued, allowed, and pending patents worldwide.
- Unveiled the AI program, including the addition of new leadership and advisory roles. The program is designed to deliver unprecedented personalized cardiac insights to its proprietary VECG technology. Data on the deep learning algorithm will be presented at two prestigious electrophysiology conferences in April and May of this year.
-
Cash and cash equivalents totaled approximately
$16.2 million
Management Commentary
“We have continued to make steady progress on regulatory and clinical milestones for the AIMIGo 3D VECG technology platform,” said Branislav Vajdic, PhD, Chief Executive Officer and Founder of HeartBeam. “We have filed a 510(k) submission to the FDA for our AIMIGo VECG device system. When cleared, this will be a major milestone for the company, as we expect this to be the first patient-held 3D VECG to be cleared by the FDA. Additionally, this clearance is the cornerstone of our regulatory efforts as it will be the basis for future FDA submissions, including our planned second FDA application on the system’s ability to synthesize a 12L ECG. We continue to anticipate that our limited launch of AIMIGo will occur by the end of 2024.
“Based on feedback from the FDA and our clinical experts, we designed the VALID-ECG clinical study, a prospective single-arm multicenter trial with the goal to validate the AIMIGo 12L ECG Synthesis Software by comparing its results with those of a standard FDA-cleared 12L ECG using both quantitative and qualitative assessment methodologies. We recently enrolled the first patients, with a plan to enroll a total of approximately 198 adult patients. We anticipate completion of enrollment in the VALID-ECG study in Q2 2024 and submission of the second 510(k) application by Q3 2024. We also previously completed an 80-patient pilot study using the same protocol as the VALID-ECG study. Based on the pilot results, we initiated the VALID-ECG study.
“During the fourth quarter, we announced significant developments related to the use of artificial intelligence (AI) applied to our VECG technology. By leveraging AI to analyze our data-rich signals, we believe we will be able to improve diagnostic accuracy and extract unique information that today’s ambulatory ECGs are unable to detect, such as complex heart rhythms, subtle signs of deteriorating heart health and cardiac events that may have previously been missed. This presents a unique opportunity to create a comprehensive repository of data that could unlock personalized AI-driven insights to improve cardiac care. Our team includes world class AI experts in previous positions with Google, Apple and Microsoft. In addition, two abstracts on our deep learning algorithm have been accepted for presentation at scientific meetings in April and May of this year. Importantly, we continued expanding our intellectual property footprint, recently receiving two new patents on our VECG technology.”
“We ended the fourth quarter of 2023 with approximately
Fourth Quarter & Full Year 2023 Financial Results
Research and development expenses for the fourth quarter of 2023 were
General and administrative expenses for the fourth quarter of 2023 were
Net loss for the fourth quarter of 2023 was
Cash and cash equivalents totaled
Fourth Quarter & Full Year 2023 Results Conference Call
HeartBeam CEO and Founder Branislav Vajdic, PhD, President Robert Eno, Consulting CFO Richard Brounstein, and VP of Regulatory Affairs Deborah Castillo, PhD, 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 via the investor relations section of the Company’s website here.
To access the call, please use the following information:
Date: |
Wednesday, March 20, 2024 |
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: |
13743963 |
Webcast: |
https://viavid.webcasts.com/starthere.jsp?ei=1652944&tp_key=9699aa7d39 |
A telephone replay will be available approximately three hours after the call and will run through June 20, 2024, by dialing 1-844-512-2921 from the
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company that is dedicated to transforming cardiac care through the power of personalized insights. The company’s proprietary vectorelectrocardiography (VECG) technology collects 3D signals of the heart’s electrical activity and converts them into a 12-lead ECG. This platform technology is designed to be used on portable, patient-friendly devices such as a credit-card sized monitor, watch or patch. 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 how cardiac health is managed in the future. 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.
HEARTBEAM, INC. |
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Balance Sheets |
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(In thousands, except share data) |
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December 31, |
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2023 |
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|
|
2022 |
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Assets |
|
|
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Current Assets: |
|
|
|
||||
Cash and cash equivalents |
$ |
16,189 |
|
|
$ |
3,594 |
|
Prepaid expenses and other current assets |
|
636 |
|
|
|
445 |
|
Total Current Assets |
$ |
16,825 |
|
|
$ |
4,039 |
|
|
|
|
|
||||
|
|
|
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Property and equipment, net |
|
256 |
|
|
|
— |
|
Other assets |
|
50 |
|
|
|
— |
|
Total Assets |
$ |
17,131 |
|
|
$ |
4,039 |
|
|
|
|
|
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Liabilities and Stockholders’ Equity |
|
|
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Current Liabilities: |
|
|
|
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Accounts payable and accrued expenses (includes related party |
|
1,194 |
|
|
|
1,665 |
|
Total Liabilities |
|
1,194 |
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|
|
1,665 |
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Commitments (Note 7) |
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Stockholders’ Equity |
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Preferred Stock - |
|
— |
|
|
|
— |
|
Common stock - |
|
3 |
|
|
|
1 |
|
Additional paid in capital |
|
52,759 |
|
|
|
24,559 |
|
Accumulated deficit |
|
(36,825 |
) |
|
|
(22,186 |
) |
Total Stockholders’ Equity |
$ |
15,937 |
|
|
$ |
2,374 |
|
|
|
|
|
||||
Total Liabilities and Stockholders’ Equity |
$ |
17,131 |
|
|
$ |
4,039 |
|
HEARTBEAM, INC. |
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Statements of Operations |
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(In thousands, except share and per share data) |
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December 31, |
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|
2023 |
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|
2022 |
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Operating Expenses: |
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General and administrative |
|
$ |
8,516 |
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|
$ |
7,354 |
|
Research and development |
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6,798 |
|
|
|
5,677 |
|
Total operating expenses |
|
|
15,314 |
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|
|
13,031 |
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Loss from operations |
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|
(15,314 |
) |
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|
(13,031 |
) |
|
|
|
|
|
||||
Other income |
|
|
|
|
||||
Interest income |
|
|
675 |
|
|
|
66 |
|
Other income |
|
|
— |
|
|
|
3 |
|
Total other income |
|
|
675 |
|
|
|
69 |
|
|
|
|
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|
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Loss before provision for income taxes |
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|
(14,639 |
) |
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|
(12,962 |
) |
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|
|
|
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Income tax provision |
|
|
— |
|
|
|
— |
|
|
|
|
|
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Net Loss |
|
$ |
(14,639 |
) |
|
$ |
(12,962 |
) |
|
|
|
|
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Net loss per share, basic and diluted |
|
$ |
(0.72 |
) |
|
$ |
(1.59 |
) |
|
|
|
|
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Weighted average common shares outstanding, basic and diluted |
|
|
20,333,280 |
|
|
|
8,168,516 |
|
HEARTBEAM, INC. |
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Statements of Cash Flows |
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(In thousands) |
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|
December 31, |
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|
|
2023 |
|
|
|
2022 |
|
Cash Flows From Operating Activities |
|
|
|
||||
Net loss |
$ |
(14,639 |
) |
|
$ |
(12,962 |
) |
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
||||
Stock-based compensation expense |
|
3,208 |
|
|
|
1,120 |
|
Changes in operating assets and liabilities: |
|
|
|
||||
Prepaid expenses and other current assets |
|
(191 |
) |
|
|
361 |
|
Accounts payable, accrued expenses and other current liabilities |
|
(471 |
) |
|
|
1,533 |
|
Net cash used in operating activities |
|
(12,093 |
) |
|
|
(9,948 |
) |
|
|
|
|
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Cash Flows From Investing Activities |
|
|
|
||||
Purchase of property and equipment |
|
(256 |
) |
|
|
— |
|
Net cash used in investing activities |
|
(256 |
) |
|
|
— |
|
|
|
|
|
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Cash Flows From Financing Activities |
|
|
|
||||
Proceeds from sale of equity, net of issuance costs |
|
24,764 |
|
|
|
348 |
|
Proceeds from exercise of stock options |
|
214 |
|
|
|
2 |
|
Proceeds from exercise of warrants |
|
16 |
|
|
|
— |
|
Net cash provided by financing activities |
|
24,994 |
|
|
|
350 |
|
|
|
|
|
||||
Net increase (decrease) in cash and restricted cash |
|
12,645 |
|
|
|
(9,598 |
) |
|
|
|
|
||||
Cash, cash equivalents and restricted cash - beginning of the year |
|
3,594 |
|
|
|
13,192 |
|
|
|
|
|
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Cash, cash equivalents and restricted cash - at end of the year |
$ |
16,239 |
|
|
$ |
3,594 |
|
|
|
|
|
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Supplemental Disclosures of Cash Flow Information: |
|
|
|
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Taxes paid |
$ |
— |
|
|
$ |
— |
|
Interest paid |
|
— |
|
|
|
— |
|
|
|
|
|
||||
Supplemental Disclosures of Non-cash Flow Information: |
|
|
|
||||
Issuance of common stock and warrants to settle accrued expenses |
$ |
— |
|
|
$ |
456 |
|
Reconciliation of cash, cash equivalents and restricted cash: |
|
|
|
||||
Cash and cash equivalents |
$ |
16,189 |
|
|
$ |
3,594 |
|
Restricted cash (included in other assets) |
$ |
50 |
|
|
$ |
— |
|
Total cash, cash equivalents and restricted cash |
$ |
16,239 |
|
|
$ |
3,594 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240320326302/en/
Investor Relations Contact:
Chris Tyson
Executive Vice President
MZ North America
Direct: 949-491-8235
BEAT@mzgroup.us
www.mzgroup.us
Media Contact:
media@heartbeam.com
Source: HeartBeam, Inc.
FAQ
What is the ticker symbol for HeartBeam, Inc.?
When does HeartBeam anticipate FDA clearance for the AIMIGo system?
What recent developments have enhanced HeartBeam's intellectual property?
How did R&D and G&A expenses change for HeartBeam in Q4 and full year 2023?
What was the net loss for HeartBeam in Q4 and full year 2023?
What was the cash and cash equivalents balance for HeartBeam as of December 31, 2023?
