- 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
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 fourth quarter and full year ended December 31,
2023.
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
as of December 31, 2023, enabling the Company to execute on
upcoming clinical and regulatory milestones. Anticipated cash
runway extends into early 2025.
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 $16.2
million in cash and cash equivalents. We are using cash at a lower
rate than anticipated, and believe we are in a strong position as
we carefully manage spending, which we believe will extend our cash
runway into early 2025. We look forward to providing updates on our
progress in the months ahead,” concluded Dr. Vajdic.
Fourth Quarter & Full Year 2023 Financial Results
Research and development expenses for the fourth quarter of 2023
were $2.0 million, compared to $1.6 million for the fourth quarter
of 2022. For the year ended December 31, 2023, Research and
development expenses increased to $6.8 million compared to $5.7
million in the same period of 2022.
General and administrative expenses for the fourth quarter of
2023 were $2.1 million compared to $2.1 million for the fourth
quarter of 2022. For the year ended December 31, 2023, G&A
expense increased to $8.5 million compared to $7.4 million in the
same period of 2022.
Net loss for the fourth quarter of 2023 was $3.9 million,
compared to a net loss of $3.7 million for the fourth quarter of
2022, and $14.6 million for the full year 2023 compared to $13.0
million in the same period of 2022.
Cash and cash equivalents totaled $16.2 million as of December
31, 2023, compared to $3.6 million as of December 31, 2022. Net
cash used in operations was $12.1 million for the year ended
December 31, 2023.
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 U.S., or 1-412-317-6671 from international
locations, and entering replay pin number: 13743963. 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
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.
Balance Sheets
(In thousands, except share
data)
December 31,
2023
2022
Assets
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
Property and equipment, net
256
—
Other assets
50
—
Total Assets
$
17,131
$
4,039
Liabilities and Stockholders’
Equity
Current Liabilities:
Accounts payable and accrued expenses
(includes related party $2 and $2, respectively)
1,194
1,665
Total Liabilities
1,194
1,665
Commitments (Note 7)
Stockholders’ Equity
Preferred Stock - $0.0001 par value;
10,000,000 shares authorized; 0 shares outstanding at December 31,
2023 and 2022
—
—
Common stock - $0.0001 par value;
100,000,000 shares authorized; 26,329,032 and 8,009,743 shares
issued and outstanding at December 31, 2023 and 2022
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.
Statements of
Operations
(In thousands, except share
and per share data)
December 31,
2023
2022
Operating Expenses:
General and administrative
$
8,516
$
7,354
Research and development
6,798
5,677
Total operating expenses
15,314
13,031
Loss from operations
(15,314
)
(13,031
)
Other income
Interest income
675
66
Other income
—
3
Total other income
675
69
Loss before provision for income taxes
(14,639
)
(12,962
)
Income tax provision
—
—
Net Loss
$
(14,639
)
$
(12,962
)
Net loss per share, basic and diluted
$
(0.72
)
$
(1.59
)
Weighted average common shares
outstanding, basic and diluted
20,333,280
8,168,516
HEARTBEAM, INC.
Statements of Cash
Flows
(In thousands)
December 31,
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
)
Cash Flows From Investing
Activities
Purchase of property and equipment
(256
)
—
Net cash used in investing
activities
(256
)
—
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
Cash, cash equivalents and restricted
cash - at end of the year
$
16,239
$
3,594
Supplemental Disclosures of Cash Flow
Information:
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
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