HeartBeam Reports Third Quarter 2024 Results
HeartBeam (NASDAQ: BEAT) reported Q3 2024 financial results, highlighting progress on its cardiac care technology. The company's FDA 510(k) submission for the HeartBeam system is under active review, with successful responses to FDA questions. Financial results show R&D expenses of $2.9M vs $1.6M in Q3 2023, and net loss of $5.0M vs $3.5M in Q3 2023. Cash position stands at $5.8M as of September 30, 2024. Key management appointments include Robert Eno as CEO, Dr. Branislav Vajdic as President, Tim Cruickshank as CFO, and Dr. Lance Myers as Chief AI Scientist.
HeartBeam (NASDAQ: BEAT) ha riportato i risultati finanziari del terzo trimestre del 2024, evidenziando i progressi nella sua tecnologia per la cura cardiaca. La richiesta FDA 510(k) per il sistema HeartBeam è attualmente in fase di revisione, con risposte positive alle domande della FDA. I risultati finanziari mostrano spese per R&S di $2.9M rispetto a $1.6M nel Q3 2023, e una perdita netta di $5.0M rispetto a $3.5M nel Q3 2023. La posizione di cassa è di $5.8M al 30 settembre 2024. Tra le nomine chiave nella direzione ci sono Robert Eno come CEO, Dr. Branislav Vajdic come Presidente, Tim Cruickshank come CFO e Dr. Lance Myers come Chief AI Scientist.
HeartBeam (NASDAQ: BEAT) reportó los resultados financieros del tercer trimestre de 2024, destacando los progresos en su tecnología de atención cardíaca. La solicitud 510(k) de la FDA para el sistema HeartBeam está en revisión activa, con respuestas exitosas a las preguntas de la FDA. Los resultados financieros muestran gastos en I+D de $2.9M frente a $1.6M en el Q3 de 2023, y pérdida neta de $5.0M frente a $3.5M en el Q3 de 2023. La posición de efectivo se sitúa en $5.8M al 30 de septiembre de 2024. Las designaciones clave incluyen a Robert Eno como CEO, Dr. Branislav Vajdic como Presidente, Tim Cruickshank como CFO y Dr. Lance Myers como Científico Principal de IA.
HeartBeam (NASDAQ: BEAT)는 2024년 3분기 재무 결과를 발표하며 심장 치료 기술에 대한 발전을 강조했습니다. HeartBeam 시스템에 대한 FDA 510(k) 제출이 활발히 검토 중이며, FDA 질문에 대한 성공적인 응답이 있었습니다. 재무 결과는 연구개발 비용이 $2.9M으로, 2023년 3분기의 $1.6M과 비교됩니다. 순손실은 $5.0M으로, 2023년 3분기의 $3.5M과 비교됩니다. 2024년 9월 30일 현재 현금 보유량은 $5.8M입니다. 주요 경영진 임명에는 Robert Eno가 CEO로, Dr. Branislav Vajdic가 사장으로, Tim Cruickshank이 CFO로, Dr. Lance Myers가 Chief AI Scientist로 임명되었습니다.
HeartBeam (NASDAQ: BEAT) a communiqué les résultats financiers du troisième trimestre 2024, mettant en lumière les progrès de sa technologie de soins cardiaques. La demande FDA 510(k) pour le système HeartBeam est actuellement en cours de révision, avec des réponses satisfaisantes aux questions de la FDA. Les résultats financiers montrent des dépenses en R&D de $2.9M contre $1.6M au T3 2023, et une perte nette de $5.0M contre $3.5M au T3 2023. La position de liquidités s'élève à $5.8M au 30 septembre 2024. Les nominations clés incluent Robert Eno en tant que CEO, Dr. Branislav Vajdic en tant que Président, Tim Cruickshank en tant que CFO et Dr. Lance Myers en tant que Chief AI Scientist.
HeartBeam (NASDAQ: BEAT) berichtete über die finanziellen Ergebnisse des dritten Quartals 2024 und hob die Fortschritte in seiner Herztechnologie hervor. Der FDA 510(k) Antrag für das HeartBeam-System wird aktiv überprüft, und es gab erfolgreiche Antworten auf Fragen der FDA. Die finanziellen Ergebnisse zeigen F&E-Ausgaben von $2.9M im Vergleich zu $1.6M im Q3 2023 und einen Nettoverlust von $5.0M im Vergleich zu $3.5M im Q3 2023. Die Kassenposition beträgt zum 30. September 2024 $5.8M. Zu den wichtigsten Ernennungen im Management gehören Robert Eno als CEO, Dr. Branislav Vajdic als Präsident, Tim Cruickshank als CFO und Dr. Lance Myers als Chief AI Scientist.
- FDA 510(k) submission progressing with successful responses to FDA questions
- Nine peer-reviewed publications and presentations covering 500+ patients
- Database of 13,000+ recordings from 250+ people demonstrating system performance
- Strategic management team expansion preparing for commercialization
- Net loss increased to $5.0M from $3.5M year-over-year
- R&D expenses increased 81% to $2.9M year-over-year
- Cash position decreased to $5.8M from $16.2M since December 2023
- Net cash burn increased to $10.3M from $9.2M year-over-year
- Continued Clinical and Regulatory Progress on the HeartBeam System
- Key Appointments to Management Team Completed as Part of Planned Evolution in Preparation for US Commercialization
- Strengthening Clinical Evidence Base, with Two Additional Studies to be Presented at the American Heart Association Conference in November 2024
- Management to Host Webcast and Conference Call Today at 4:30 p.m. ET
Third Quarter & Subsequent 2024 Operational Highlights
The Company continues to make steady progress toward key clinical and regulatory milestones on the HeartBeam system.
FDA 510(k) Submission:
- The 510(k) submission for the HeartBeam system continues to progress through active review by the FDA.
- The Company has successfully responded to the questions asked by the FDA and is currently working through clarifications.
- HeartBeam continues to be confident in FDA clearance as the Company works interactively through the process.
- Upon the initial 510(k) clearance, the Company is prepared to start an Early Access Program to obtain important feedback on the use of the system by patients, prescribing physicians, and a cardiologist reader service.
12-Lead Synthesis Software FDA Submission:
- HeartBeam has completed two pre-submission meetings with the FDA on the planned second 510(k) submission focused on the algorithms that convert the 360-degree signals captured by the HeartBeam system into a synthesized 12-lead ECG.
- The Company currently anticipates submitting the 510(k) application soon after receiving clearance for the initial HeartBeam system.
- Upon receiving 510(k) clearance for the 12-lead synthesis software, the Company anticipates initiating a limited commercial launch.
Key Appointments to Management Team Completed:
- Long-planned evolution of the team in preparation for US commercialization.
-
Robert Eno appointed as Chief Executive Officer.
- Mr. Eno is an industry leader who brings extensive experience in developing go-to-market strategies for breakthrough products and delivering growth.
- Mr. Eno joined HeartBeam as President in January 2023 and will lead as the Company continues to work towards securing the foundational FDA 510(k) clearance for its vector-based technology and prepares for commercialization and growth.
-
Branislav Vajdic, Ph.D., Founder of HeartBeam, appointed as President.
- Dr. Vajdic will be focused on innovating on the Company’s groundbreaking vector-based technology, driving research and development efforts, and advancing artificial intelligence (AI) applications.
-
Tim Cruickshank appointed as Chief Financial Officer.
- Mr. Cruickshank brings more than 15 years of public company experience with a focus on growing businesses with disruptive technologies and taking clinical-stage companies to commercial operating entities.
-
Lance Myers, Ph.D., appointed as Chief Artificial Intelligence (AI) Scientist.
- Dr. Myers is a pioneer in digital health data analytics and body-worn biosensor technologies, and was previously Head of Data Science at Verily (Google Life Sciences).
- In this newly created position, Dr. Myers will play a pivotal role in guiding how AI is applied to the Company’s core technology.
Other Highlights:
-
Significant and growing body of clinical evidence on HeartBeam’s technology:
- Nine peer-reviewed publications and presentations on studies that have enrolled more than 500 patients combined, demonstrating the technology’s pivotal role in advancing cardiac care.
- At the American Heart Association (AHA) conference later this month, results will be presented from a pilot study comparing HeartBeam’s synthesized 12-lead ECG to a standard 12-lead ECG for arrhythmia detection.
- The pilot study is a precursor to the US pivotal study, which will be part of the FDA 510(k) submission for the 12-lead synthesis software.
- Also, at AHA, data will be presented on a novel algorithm, used in conjunction with the HeartBeam ECG technology, in detecting heart attacks.
- HeartBeam has more than 13,000 recordings from more than 250 people, providing meaningful insights about the performance and usability of the system.
- HeartBeam was named “Rising Star” at the 6th Annual Digital Health Hub Foundation Awards in the Home Health Diagnostic Category.
-
Cash and cash equivalents totaled approximately
$5.8 million $3.3 million
Management Commentary
“The third quarter of 2024 was highlighted by significant steps towards transitioning into a commercial stage company and building a strong foundation for long-term success. We continued to make progress with anticipated regulatory milestones for HeartBeam’s novel vector-based technology. Our optimism continues in FDA clearance for the HeartBeam system and are on track for the planned second 510(k) submission,” said Rob Eno, Chief Executive Officer, HeartBeam.
“As we are on the cusp of US commercialization, we evolved our management team to ensure we have the right leaders in place to execute a successful launch. I am honored to lead the Company at this pivotal phase and am thrilled to work alongside talented leaders like Tim and Lance as we work to make the HeartBeam technology available to patients and physicians. Branislav’s vision and drive to change how cardiac care is managed is what got the company to this point, and I look forward to my continued partnership with him.”
“We also continue to build on the body of clinical evidence for our groundbreaking technology. All these actions are steps towards our long-term vision of transforming the monitoring and detection of cardiac conditions through our vector-based technology,” he continued.
Third Quarter 2024 Financial Results
Research and development expenses for the third quarter of 2024 were
General and administrative expenses for the third quarter of 2024 were
Net loss for the third quarter of 2024 was
Cash and cash equivalents totaled
Third Quarter 2024 Results Conference Call
HeartBeam CEO Robert Eno, President and Founder Branislav Vajdic, PhD, and Chief Financial Officer Tim 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 via the investor relations section of the Company’s website here.
To access the call, please use the following information:
Date: |
Thursday, November 7, 2024 |
Time: |
4:30 p.m. Eastern time (1:30 p.m. Pacific time) |
Dial-in: |
1-800-717-1738 |
International Dial-in: |
1-646-307-1865 |
Conference Code: |
1101650 |
Webcast: |
https://viavid.webcasts.com/starthere.jsp?ei=1692718&tp_key=af2e025952 |
A telephone replay will be available approximately three hours after the call and will run through February 7, 2025, by dialing 1-844-512-2921 from the
About HeartBeam, Inc.
HeartBeam, Inc. (NASDAQ: BEAT) is a medical technology company dedicated to transforming cardiac care by providing powerful cardiac insights wherever the patient is. The Company is creating the first ever cable-free 12-lead ECG capable of capturing the heart’s electrical signals from three dimensions. This platform technology is designed to be used in 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 holds 13 US and 4 international issued patents 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.
HEARTBEAM, INC. Condensed Balance Sheets (Unaudited) (In thousands, except share data)
|
|||||||
|
September 30,
|
|
December 31,
|
||||
Assets |
|
|
|
||||
Current Assets: |
|
|
|
||||
Cash and cash equivalents |
$ |
5,768 |
|
|
$ |
16,189 |
|
Prepaid expenses and other current assets |
|
376 |
|
|
|
636 |
|
Total Current Assets |
|
6,144 |
|
|
|
16,825 |
|
|
|
|
|
||||
Property and equipment, net |
|
457 |
|
|
|
256 |
|
Other assets |
|
56 |
|
|
|
50 |
|
Total Assets |
$ |
6,657 |
|
|
$ |
17,131 |
|
|
|
|
|
||||
|
|
|
|
||||
|
|
|
|
||||
Liabilities and Stockholders’ Equity |
|
|
|
||||
Current Liabilities: |
|
|
|
||||
Accounts payable and accrued expenses (includes related party |
$ |
1,856 |
|
|
$ |
1,194 |
|
Total Current Liabilities |
|
1,856 |
|
|
|
1,194 |
|
|
|
|
|
||||
Total Liabilities |
|
1,856 |
|
|
|
1,194 |
|
|
|
|
|
||||
Commitments (Note 7) |
|
|
|
||||
|
|
|
|
||||
Stockholders’ Equity |
|
|
|
||||
Preferred stock - |
|
— |
|
|
|
— |
|
Common stock - |
|
3 |
|
|
|
3 |
|
Additional paid in capital |
|
56,164 |
|
|
|
52,759 |
|
Accumulated deficit |
|
(51,366 |
) |
|
|
(36,825 |
) |
Total Stockholders’ Equity |
|
4,801 |
|
|
|
15,937 |
|
|
|
|
|
||||
Total Liabilities and Stockholders’ Equity |
$ |
6,657 |
|
|
$ |
17,131 |
|
See accompanying notes to the condensed unaudited financial statements
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, |
||||||||||||
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Operating Expenses: |
|
|
|
|
|
|
|
||||||||
General and administrative |
$ |
2,176 |
|
|
$ |
2,114 |
|
|
$ |
6,778 |
|
|
$ |
6,417 |
|
Research and development |
|
2,893 |
|
|
|
1,623 |
|
|
|
8,165 |
|
|
|
4,788 |
|
Total operating expenses |
|
5,069 |
|
|
|
3,737 |
|
|
|
14,943 |
|
|
|
11,205 |
|
|
|
|
|
|
|
|
|
||||||||
Loss from operations |
|
(5,069 |
) |
|
|
(3,737 |
) |
|
|
(14,943 |
) |
|
|
(11,205 |
) |
|
|
|
|
|
|
|
|
||||||||
Other Income and (Expense) |
|
|
|
|
|
|
|
||||||||
Interest income |
|
96 |
|
|
|
267 |
|
|
|
408 |
|
|
|
445 |
|
Other expense |
|
(6 |
) |
|
|
— |
|
|
|
(6 |
) |
|
|
— |
|
Total other income |
|
90 |
|
|
|
267 |
|
|
|
402 |
|
|
|
445 |
|
|
|
|
|
|
|
|
|
||||||||
Loss before provision for income taxes |
|
(4,979 |
) |
|
|
(3,470 |
) |
|
|
(14,541 |
) |
|
|
(10,760 |
) |
|
|
|
|
|
|
|
|
||||||||
Income tax provision |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
||||||||
Net Loss |
$ |
(4,979 |
) |
|
$ |
(3,470 |
) |
|
$ |
(14,541 |
) |
|
$ |
(10,760 |
) |
|
|
|
|
|
|
|
|
||||||||
Net loss per share, basic and diluted |
$ |
(0.19 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.55 |
) |
|
$ |
(0.59 |
) |
|
|
|
|
|
|
|
|
||||||||
Weighted average common shares outstanding, basic and diluted |
|
26,752,297 |
|
|
|
26,449,168 |
|
|
|
26,610,760 |
|
|
|
18,252,654 |
|
See accompanying notes to the condensed unaudited financial statements
HEARTBEAM, INC. Condensed Statements of Cash Flows (Unaudited) (In thousands)
|
|||||||
|
Nine Months ended September 30, |
||||||
|
|
2024 |
|
|
|
2023 |
|
Cash Flows From Operating Activities |
|
|
|
||||
Net loss |
$ |
(14,541 |
) |
|
$ |
(10,760 |
) |
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
||||
Stock based compensation expense |
|
3,300 |
|
|
|
2,021 |
|
Changes in operating assets and liabilities: |
|
|
|
||||
Prepaid expenses and other current assets |
|
260 |
|
|
|
150 |
|
Accounts payable and accrued expenses |
|
662 |
|
|
|
(646 |
) |
Net cash used in operating activities |
|
(10,319 |
) |
|
|
(9,235 |
) |
|
|
|
|
||||
Cash Flows From Investing Activities |
|
|
|
||||
Purchase of property and equipment |
|
(201 |
) |
|
|
(144 |
) |
Net cash used in investing activities |
|
(201 |
) |
|
|
(144 |
) |
|
|
|
|
||||
Cash Flows From Financing Activities |
|
|
|
||||
Proceeds from sale of equity, net of issuance costs |
|
76 |
|
|
|
24,764 |
|
Proceeds from exercise of stock options |
|
29 |
|
|
|
214 |
|
Proceeds from exercise of warrants |
|
— |
|
|
|
16 |
|
Net cash provided by financing activities |
|
105 |
|
|
|
24,994 |
|
|
|
|
|
||||
Net increase (decrease) in cash and restricted cash |
|
(10,415 |
) |
|
|
15,615 |
|
Cash, cash equivalents and restricted cash – Beginning of period |
|
16,239 |
|
|
|
3,594 |
|
|
|
|
|
||||
Cash, cash equivalents and restricted cash – Ending of period |
$ |
5,824 |
|
|
$ |
19,209 |
|
|
|
|
|
||||
Reconciliation of cash, cash equivalents and restricted cash: |
|
|
|
||||
Cash and cash equivalents |
$ |
5,768 |
|
|
$ |
19,184 |
|
Restricted cash (included in other assets) |
|
56 |
|
|
|
25 |
|
Total cash, cash equivalents and restricted cash |
$ |
5,824 |
|
|
$ |
19,209 |
|
See accompanying notes to the condensed unaudited financial statements
View source version on businesswire.com: https://www.businesswire.com/news/home/20241107355916/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 were HeartBeam's (BEAT) Q3 2024 financial results?
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