Initiates Strategic Partnerships to Advance
Emergency Department (ED) Myocardial Infarction (MI) Software
Product & Telehealth Solution Toward FDA Submission
Recent IPO Proceeds Provide Ample Cash Runway
to Commercialization in FY 2022 and FY 2023
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 Electrocardiogram
(“ECG”) telemedicine technology for heart attack detection, has
reported its financial and operational results for the fourth
quarter and full year ended December 31, 2021.
Fourth Quarter 2021 and Subsequent 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.
- Partnered with Phoebe Putney Health System, signed a Business
Associate Agreement (“BAA”) and Clinical Trial Agreement (“CTA”) to
conduct a pilot study 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
hosted on a web browser, and for remote patient monitoring (“RPM”)
to connect physicians and patients.
- 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, MS, MD, was appointed as Chairman
of the new SAB.
- Appointed commercial medical device veteran Alan Baumel as
Chief Operating Officer to lead rollout of HeartBeam’s initial two
products.
- On November 15, 2021, successfully completed its initial public
offering (IPO), selling 2,750,000 shares to the public at $6.00 per
Unit, and 3,125,000 five-year warrants to acquire one share of
common stock with an exercise price of $6.00 per share.
- Net proceeds raised in HeartBeam’s IPO were $14.9 million,
after deducting underwriting discounts and commissions. The Company
subsequently sold an additional 58,000 shares and five-years
warrants at $6.00 per share, all unregistered, for an additional
$348,000 in net proceeds.
- Presented at the H.C. Wainwright BIOCONNECT Conference and
ED-MID diagnostics software research data at the 43rd Annual
International Conference of the IEEE Engineering in Medicine and
Biology Society.
Management Commentary
“Our fourth quarter of 2021 milestone transition to a public
company was promptly followed by two significant strategic
partnerships for our ED software product in the new year,” said
Branislav Vajdic, PhD, Chief Executive Officer and Founder of
HeartBeam. “Our partnership with LIVMOR to develop a HeartBeam
branded version of its FDA cleared LIVMOR RPM platform, customized
for our products, will enable us to further increase our confidence
in staying on schedule for FDA submission of our heart attack
detection software solution for ED settings. We are collaborating
closely with the LIVMOR team to ready our software for the planned
submission to the FDA during the next quarter.
“We have also partnered with Phoebe Putney Health System in
Georgia to conduct our first pilot study in a clinical setting
designed to evaluate our ED software product. After this initial
study we have plans for additional pilot studies for our end-to-end
prescription-only telehealth system for remote heart attack
detection in at risk patients, as well as other future scientific
and commercial collaboration with Phoebe Putney.
“We believe we are making strides to bring our products to
market following FDA market clearance. We have continued to
position the company for rollout success with the appointment of
Alan Baumel as Chief Operating Officer. Alan’s deep experience with
cardiac devices and extensive industry knowledge will be
instrumental in managing the preparations to accelerate and scale
our commercialization path as we ready the product development for
FDA submission.
“We have also begun establishing our Scientific Advisory Board
with the appointment of world-renowned cardiologist C. M. Michael
Gibson, MS, MD, as Chairman to drive success in the use of our
technology,” Mr. Vajdic stated.
“The commercial team has identified key target accounts for both
the HeartBeam ED and telehealth product and has engaged in a number
of productive discussions on partnering with these key
institutions. The target accounts include large academic
institutions, regional healthcare systems in the Southeast and
Mid-Atlantic, and regional community systems in the Western US.
Overall, there has been a very positive response to the HeartBeam
technology, and several systems are willing to conduct pilot
evaluations of our ED software solution as soon as we receive FDA
clearance for the product. The goal for the commercial team is to
transition the participating centers to a revenue account at the
conclusion of the pilot evaluation,” said Jon Hunt, Chief Business
Officer of HeartBeam.
“During 2021 we made significant advancements for our products,
and we begin 2022 with increased momentum, resources and
enthusiasm,” continued Mr. Vajdic. “I am pleased to report that we
recently announced our partnership with Triple Ring Technologies to
assist in the design and development of our disruptive telehealth
complete solution, a 3D vector ECG collection device for remote
heart attack monitoring. This joint effort will be a five-phase
expedited device development project to rapidly build and test our
3D vector collection device that delivers mission critical health
data to physicians in real-time. For the first time outside of a
medical setting, we expect that physicians will be able to
determine with a patient-friendly device if chest pains are due to
a heart attack, something that no other telehealth consumer product
offers today.
“Looking ahead, with our transition to a public company and the
addition of new capital to accelerate our commercialization path we
remain confident in our anticipated upcoming product milestones. By
the end of 2022 we expect full commercial roll-out of our ED
Software Tool after it is cleared by the FDA, and our Telehealth
solution submitted to the FDA for clearance. We approach these
milestones from a position of strength, with an experienced team
and new partnerships to support our goals. We look forward to
providing you additional updates in the near-term as we move toward
commercialization,” concluded Mr. Vajdic.
Rick Brounstein, Chief Financial Officer of HeartBeam, added,
“With the successful completion of our IPO in November, we ended
2021 with over $13.2 million in cash and cash equivalents, compared
to $795,000 as of September 30, 2021, and $24,000 as of December
31, 2020. We expect our cash position to provide sufficient runway
into 2023. With the planned 2022 release of our ED product, we
continue to believe we have sufficient cash to meet our
development, regulatory and commercialization milestones without
the need to raise additional funds at least through the achievement
of FDA clearance of our telehealth product in 2023.”
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 - Q3 2022
- Product Launch - Q4 2022
- Telehealth
- Development of FDA-Ready Product - Q3 2022
- FDA Study Completed - Q3 2022
- FDA Submission – Q4 2022
- FDA Clearance - Q1 2023
- Limited Market Release - Q1 2023
- Product Launch - Q2 2023
Fourth Quarter and Full Year 2021 Financial Results
Research and development expenses for the fourth quarter of 2021
were $96,000, compared to $47,000 for the fourth quarter of 2020.
For the year ended December 31, 2021, Research and development
expenses increased to $255,000 from $133,000 the prior year.
General and administrative expenses for the fourth quarter of
2021 were $1.2 million compared to $214,000 for the fourth quarter
of 2020. For the year ended December 31, 2021, G&A expense
increased to $2.0 million compared to $655,000 in the same period
of 2020, as we prepared for and transitioned to becoming a public
company.
Net loss for the fourth quarter of 2021 was $2.1 million,
compared to a net loss of $335,000 for the fourth quarter of 2020,
and $4.4 million for the full year 2021 compared to $1.1 million in
the year ago period.
Cash totaled $13.2 million as of December 31, 2021, compared to
$795,000 as of September 30, 2021 and $24,000 as of December 31,
2020.
Fourth Quarter and Full Year 2021 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, March 24, 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:
13727295
Webcast:
https://viavid.webcasts.com/starthere.jsp?ei=1530957&tp_key=53b3c7ab88
A telephone replay will be available approximately two hours
after the call and will run through June 24, 2022 by dialing
1-844-512-2921 from the U.S., or 1-412-317-6671 from international
locations, and entering replay pin number: 13727295. 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)
December 31,
2021
2020
Assets
Current Assets:
Cash
$
13,192
$
24
Prepaid expenses and other assets
806
27
Total Assets
$
13,998
$
51
Liabilities and Stockholders’ Equity
(Deficit)
Current Liabilities:
Accounts payable and accrued expenses
(includes related party $1 and $15, respectively)
588
489
Convertible notes, net
—
4,295
Other - current liabilities
—
52
Total Liabilities
588
4,836
Commitments and contingencies (Note 8)
Stockholders’ Equity (Deficit)
Common stock - $0.0001 par value;
20,000,000 shares authorized; 7,809,912 and 3,527,850 shares issued
and outstanding at December 31, 2021 and 2020
1
—
Additional paid in capital
22,633
11
Accumulated deficit
(9,224
)
(4,796
)
Total Stockholders’ Equity (Deficit)
$
13,410
$
(4,785
)
Total Liabilities and Stockholders’ Equity
(Deficit)
$
13,998
$
51
HEARTBEAM, INC.
Statements of Operations
(Unaudited)
(In thousands, except share
and per share data)
December 31,
2021
2020
Operating Expenses:
General and administrative
$
2,030
$
655
Research and development
255
133
Total operating expenses
2,285
788
Loss from operations
(2,285
)
(788
)
Other Income (Expense)
Interest expense
(2,165
)
(280
)
Other Income
22
—
Total other income (expense)
(2,143
)
(280
)
Loss before provision for income taxes
(4,428
)
(1,068
)
Income tax provision
—
—
Net Loss
$
(4,428
)
$
(1,068
)
Net loss per share, basic and diluted
$
(1.03
)
$
(0.29
)
Weighted average common shares
outstanding, basic and diluted
4,284,714
3,645,944
HEARTBEAM, INC.
Statements of Cash Flows
(Unaudited)
(In thousands)
December 31,
2021
2020
Cash Flows From Operating
Activities
Net loss
$
(4,428
)
$
(1,068
)
Adjustments to reconcile net loss to net
cash used in operating activities
Accretion expense, convertible notes
1,886
—
Non-cash interest expense
278
248
Stock-based compensation expense
192
10
Amortization of debt issuance cost
—
28
PPP loan forgiveness
(22
)
—
Changes in operating assets and
liabilities:
Prepaid expenses and other current
assets
(779
)
(25
)
Accounts payable, accrued expenses and
other current liabilities
(357
)
207
Net cash used in operating
activities
(3,230
)
(600
)
Cash Flows From Financing
Activities
Proceeds from sale of equity in IPO,
net
14,713
—
Proceeds from issuance of convertible
notes
1,715
617
Proceeds from PPP & EIDL Loans
—
22
Repayment and interest paid on short-term
loans
(30
)
(20
)
Net cash provided by financing
activities
16,398
619
Net increase in cash
13,168
19
Cash – Beginning of the year
24
5
Cash – End of the year
$
13,192
$
24
Supplemental Disclosures of Cash Flow
Information:
Taxes paid
$
—
$
—
Interest paid
—
4
Supplemental Disclosures of Non-cash
Flow Information:
Conversion of debt to equity
6,288
—
Debt discount
1,886
—
Common stock and awards accrued but not
issued
456
—
Non-cash - accounts payable converted to
short term debt
—
30
Conversion of short-term notes to
convertible notes
$
—
$
22
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220324005199/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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