- 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
HeartBeam, Inc. (NASDAQ: BEAT), a medical technology
company focused on transforming cardiac care through the power of
personalized insights, has reported its financial and operational
results for the third quarter ended September 30, 2024.
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 as
of September 30, 2024, with net cash used in operating activities
of $3.3 million during the period.
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 $2.9 million, compared to $1.6 million for the third quarter
of 2023.
General and administrative expenses for the third quarter of
2024 were $2.2 million compared to $2.1 million for the third
quarter of 2023.
Net loss for the third quarter of 2024 was $5.0 million,
compared to a net loss of $3.5 million for the third quarter of
2023.
Cash and cash equivalents totaled $5.8 million as of September
30, 2024, compared to $16.2 million as of December 31, 2023. Net
cash used in operations was $10.3 million for the nine-month period
ended September 30, 2024, compared to $9.2 million for the
nine-month period ended September 30, 2023.
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 U.S., or 1-412-317-6671 from international
locations, and entering replay pin number: 1101650. 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 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,
2024
December 31,
2023
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 $5 and $2, respectively)
$
1,856
$
1,194
Total Current Liabilities
1,856
1,194
Total Liabilities
1,856
1,194
Commitments (Note 7)
Stockholders’ Equity
Preferred stock - $0.0001 par value;
10,000,000 authorized; 0 shares outstanding at September 30, 2024
and December 31, 2023
—
—
Common stock - $0.0001 par value
100,000,000 shares authorized; 26,594,928 and 26,329,032 shares
issued and outstanding at September 30, 2024 and December 31, 2023,
respectively
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
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