Company Remains on Track for FDA Submission of
Emergency Department (ED) Myocardial Infarction (MI) Software
Product in Q2 2022 & Telehealth Solution in Q4 2022
Management to Host Webcast and Conference Call
Today At 4:30 p.m. ET
HeartBeam, Inc. (NASDAQ: BEAT), a developmental stage
digital healthcare company with a proprietary ECG telemedicine
technology for heart attack detection, has reported its financial
and operational results for the first quarter ended March 31,
2022.
First Quarter 2022 Operational Highlights
- Engaged Triple Ring Technologies to co-develop its telehealth
complete solution 3D vector ECG collection device for remote heart
attack, Myocardial Infarction (“MI”), monitoring.
- Engaged multiple partner health systems for ECG data sets to
ensure FDA submission in Q2 2022.
- Partnered with Phoebe Putney Health System, signed a Business
Associate Agreement and Clinical Trial Agreement to provide ECG
data for this clinical trial designed to evaluate HeartBeam’s
Emergency Department (“ED”) MI software product.
- Signed a partnership agreement with LIVMOR Inc., a digital
health solutions company, to build a HeartBeam branded version of
LIVMOR’s Halo+ FDA cleared platform for both use in the ED and for
remote patient monitoring of patients with high risk for MI.
- Established a Scientific Advisory Board (“SAB”) to provide
scientific guidance and insight to HeartBeam’s medical studies,
research, and product pipelines. In conjunction, world-renowned
cardiologist C. Michael Gibson, MD, MS, was appointed as Chairman
of the SAB.
Management Commentary
“We continue to operate from a position of strength, equipped
with multiple strategic partnerships to advance product
development, near-term milestones and cash runway into 2023,” said
Branislav Vajdic, PhD, Chief Executive Officer and Founder of
HeartBeam. “In collaboration with our LIVMOR partners our team
continues to execute, readying our software for the planned
submission to the FDA during the second quarter. Our partnership
with Triple Ring Technologies is off to great start. The combined
HeartBeam and Triple Ring team is making rapid progress in getting
our 3D vector ECG collection device ready for FDA submission in Q4
of this year and readying it for production after FDA clearance,”
commented Dr. Vajdic.
“Taken together, we believe our commercialization path is on
track to bring our products to market following FDA market
clearance. In anticipation, our commercial team has continued to
engage in positive discussions with strategic institutions,
including academic centers, regional healthcare systems in the
Southeast and Mid-Atlantic, and regional community hospital systems
in the Western US that can utilize our products. Several of these
target accounts have expressed willingness to conduct pilot
evaluations of our ED software solution as soon as we receive FDA
clearance for the product,” said Jon Hunt, Ph.D. HeartBeam’s Chief
Business Officer.
“Armed with sufficient capital to execute our commercialization
path, we remain confident in our anticipated upcoming product
milestones. During the first quarter of 2023, we expect full
commercial roll-out of our ED Software Tool after it is cleared by
the FDA, and by the end of 2022 our Telehealth solution submitted
to the FDA for clearance. We look forward to providing you
additional updates in the near-term as we move toward FDA
submission and commercialization,” concluded Dr. Vajdic.
Anticipated Milestones
- ER Software Tool (ED-MID)
- Development of FDA-Ready Product - Q2 2022
- FDA Study Completed - Q2 2022
- FDA Submission - Q2 2022
- FDA Clearance - Q3 2022
- Limited Market Release – Q4 2022
- Product Launch – Q1 2023
- Telehealth
- Development of FDA-Ready Product – Q4 2022
- FDA Study Completed – Q4 2022
- FDA Submission – Q4 2022
- FDA Clearance - Q1 2023
- Limited Market Release – Q2 2023
- Product Launch – Q3 2023
First Quarter 2022 Financial Results
Research and development expenses for the first quarter of 2022
were $734,000, compared to $29,000 for the first quarter of
2021.
General and administrative expenses for the first quarter of
2022 were $1.4 million compared to $134,000 for the first quarter
of 2021.
Net loss for the first quarter of 2022 was $2.1 million,
compared to a net loss of $210,000 for the first quarter of
2021.
Cash totaled $11.2 million as of March 31, 2022, compared to
$13.2 million as of December 31, 2021.
First Quarter 2022 Results Conference Call
HeartBeam CEO and Founder Branislav Vajdic, PhD, CFO Rick
Brounstein, and CBO Jon Hunt, 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:
Thursday, May 12, 2022
Time:
4:30 p.m. Eastern time (1:30 p.m. Pacific
time)
Dial-in:
1-877-423-9813
International Dial-in:
1-201-689-8573
Conference Code:
13728960
Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1542931&tp_key=28a3a9a236
A telephone replay will be available approximately two hours
after the call and will run through July 12, 2022 by dialing
1-844-512-2921 from the U.S., or 1-412-317-6671 from international
locations, and entering replay pin number: 13728960. The replay can
also be viewed through the webinar 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 development stage digital
healthcare company with proprietary ECG telemedicine technology
that will redefine the way high risk cardiovascular patients are
diagnosed in an ambulatory setting at any time and any place. Its
breakthrough solution employs a reusable, credit card sized, 3D
vector ECG recording device and cloud-based software capable of
assisting a physician in diagnosing a wide range of cardiovascular
disease. HeartBeam is initially focusing on a huge unmet need of
helping diagnose heart attacks in patients outside of a medical
institution. No single lead ECG technology can offer this value to
patients and their physicians. This underserved market is several
times larger than the cardiac arrhythmia detection market based on
the prevalence of patients with coronary artery disease at high
risk of heart attack. For more information visit
www.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 recently filed Registration Statement on Form S-1, which can
be found on the SEC’s website 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
(Unaudited)
(In thousands, except share
data)
March 31, 2022
December 31,
2021
Assets
Current Assets:
Cash
$
11,201
$
13,192
Prepaid expenses and other assets
1,540
806
Total Assets
$
12,741
$
13,998
Liabilities and Stockholders’
Equity
Current Liabilities:
Accounts payable and accrued expenses
(includes related party $3 and $1, respectively)
514
588
Total Liabilities
514
588
Commitments and contingencies (Note 7)
Stockholders’ Equity
Common stock - $0.0001 par value;
20,000,000 shares authorized; 7,958,888 and 7,809,912 shares issued
and outstanding at March 31, 2022 and December 31, 2021
1
1
Additional paid in capital
23,596
22,633
Accumulated deficit
(11,370
)
(9,224
)
Total Stockholders’ Equity
$
12,227
$
13,410
Total Liabilities and Stockholders’
Equity
$
12,741
$
13,998
HEARTBEAM, INC.
Statements of Operations
(Unaudited)
(In thousands, except share
and per share data)
Three months ended March
31,
2022
2021
Operating Expenses:
General and administrative
$
1,414
$
134
Research and development
734
29
Total operating expenses
2,148
163
Loss from operations
(2,148
)
(163
)
Other Income
Interest income (expense)
2
(69
)
Other income
—
22
Total other income (expense)
2
(47
)
Loss before provision for income taxes
$
(2,146
)
$
(210
)
Income tax provision
$
—
$
—
Net Loss
$
(2,146
)
$
(210
)
Net loss per share, basic and diluted
$
(0.27
)
$
(0.06
)
Weighted average common shares
outstanding, basic and diluted
8,081,804
3,684,804
HEARTBEAM, INC.
Statements of Cash Flows
(Unaudited)
(In thousands)
Three months ended March
31,
2022
2021
Cash Flows From Operating
Activities
Net loss
$
(2,146
)
$
(210
)
Adjustments to reconcile net loss to net
cash used in operating activities
Non-cash interest expense
—
69
Stock-based compensation expense
159
9
PPP loan forgiveness
—
(22
)
Changes in operating assets and
liabilities:
Prepaid expenses and other current
assets
(734
)
—
Accounts payable and accrued expenses
382
(1
)
Net cash used in operating
activities
(2,339
)
(155
)
Cash Flows From Financing
Activities
Proceeds from sale of equity
348
—
Proceeds from issuance of convertible
notes
—
215
Net cash provided by financing
activities
348
215
Net increase (decrease) in cash
(1,991
)
60
Cash – Beginning of period
13,192
24
Cash – Ending of period
$
11,201
$
84
Supplemental Disclosures of Cash Flow
Information:
Taxes paid
$
—
$
—
Supplemental Disclosures of Non-cash
Financing Activities:
Issuance of common stock and warrants to
settle accrued expenses
$
456
$
—
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220512005925/en/
Media and Investor Relations Contact: Chris Tyson
Executive Vice President MZ North America Direct: 949-491-8235
BEAT@mzgroup.us www.mzgroup.us
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