HeartBeam Reports First Quarter 2022 Financial Results
HeartBeam, a digital healthcare company (NASDAQ: BEAT), reported its Q1 2022 results, highlighting a net loss of $2.1 million, up from $210,000 in Q1 2021. R&D expenses increased significantly to $734,000, compared to $29,000 in the prior year. The company remains on track for an FDA submission for its Emergency Department Myocardial Infarction software in Q2 2022 and a Telehealth solution in Q4 2022. With cash reserves of $11.2 million, HeartBeam anticipates a full commercial rollout of its ED Software Tool in Q1 2023.
- Anticipated FDA submission for ED-MID software in Q2 2022.
- Established partnerships with healthcare systems and technology companies for product development.
- Sufficient capital of $11.2 million to support commercialization efforts.
- Net loss increased to $2.1 million in Q1 2022.
- R&D expenses rose to $734,000, indicating higher operational costs.
Company Remains on Track for FDA Submission of
Management to Host Webcast and Conference Call Today At
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’sEmergency Department (“ED”) MI software product.
-
Partnered with
-
Signed a partnership agreement with
LIVMOR Inc. , a digital health solutions company, to build aHeartBeam 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 cardiologistC. Michael Gibson , MD, MS, was appointed as Chairman of theSAB .
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
“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
“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
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
General and administrative expenses for the first quarter of 2022 were
Net loss for the first quarter of 2022 was
Cash totaled
First Quarter 2022 Results Conference Call
To access the call, please use the following information:
Date: |
|
|
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
About
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.
Balance Sheets (Unaudited) (In thousands, except share data) |
|||||||
|
|
|
|
||||
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 |
|
514 |
|
|
|
588 |
|
Total Liabilities |
|
514 |
|
|
|
588 |
|
|
|
|
|
||||
Commitments and contingencies (Note 7) |
|
|
|
||||
|
|
|
|
||||
Stockholders’ Equity |
|
|
|
||||
Common stock - |
|
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 |
|
Statements of Operations (Unaudited) (In thousands, except share and per share data) |
|||||||
|
Three months ended |
||||||
|
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 |
|
Statements of Cash Flows (Unaudited) (In thousands) |
|||||||
|
Three months ended |
||||||
|
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:
Executive Vice President
Direct: 949-491-8235
BEAT@mzgroup.us
www.mzgroup.us
Source:
FAQ
What are HeartBeam's anticipated milestones for FDA approvals in 2022?
What was HeartBeam's net loss for the first quarter of 2022?
How much cash does HeartBeam have as of March 31, 2022?
When does HeartBeam plan to launch its ED Software Tool?
