HeartBeam Reports Second Quarter 2022 Financial Results

Rhea-AI Summary

HeartBeam, Inc. (NASDAQ: BEAT) reported its Q2 2022 financial and operational results, highlighting significant advancements towards FDA submissions for its HeartBeam AIMI™ software platform and AIMIGo™ telehealth solution. The company plans to submit the AIMI platform for FDA clearance around August 15, 2022, and aims for AIMIGo submission in Q4 2022. Q2 net loss was $3.5 million, with cash reserves at $9.3 million. HeartBeam expanded its target patient population by including unstable angina, enhancing the platform's clinical validation study scope.

Positive

• FDA submission for HeartBeam AIMI platform expected by August 15, 2022, indicating progress.
• Expansion of target population to include unstable angina, enhancing clinical study scope.
• Acquisition of source code for LIVMOR Portal to expedite development of in-house solutions.

Negative

• Net loss increased to $3.5 million in Q2 2022 from $0.9 million in Q2 2021.
• Research and development expenses surged to $1.7 million, up from $25,000 year-over-year.
• Cash reserves decreased to $9.3 million from $13.2 million since the end of 2021.

Company Remains on Track for FDA Submissions of the HeartBeam AIMI™ Software Platform for the Emergency Department in Q3 2022 & AIMIGo™, the Telehealth Solution, in Q4 2022

Acquires Source Code Access Under the LivMor Partnership Agreement that will be Used to Build a Company-branded Version of the LIVMOR’s Halo+ FDA Cleared Turnkey Solution for Remote Patient Monitoring to Connect Physicians and Patients.

Management to Host Webcast and Conference Call Today At 4:30 p.m. ET

SANTA CLARA, Calif.--(BUSINESS WIRE)-- 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 second quarter ended June 30, 2022.

Second Quarter 2022 Operational Highlights

• Expanded the addressable patient population for the Company’s HeartBeam AIMI™ software platform to provide access to a broader patient population in the Emergency Room
• Submission of HeartBeam AIMI platform to FDA expected on or about August 15, 2022
• Supplemented LIVMOR partnership with source code acquisition for the HeartBeam branded version of the FDA Registered LIVMOR Halo+ Portal used with both of the Company’s products
• Appointed healthcare and cardiac industry veteran, Ken Persen, to the role of Chief Technology Officer
• Selected as winner of the annual Cardiovascular Innovations (CVI) 2022 Innovation Summit and Shark Tank Competition, an annual awards program recognizing state-of-the-art cardiac technologies
• Presented at investor conferences including the H.C. Wainwright Global Investment Conference and the LD Micro Invitational XII Conference

Management Commentary

“The second quarter of 2022 delivered steady advancement along our commercialization pathway, including HeartBeam AIMI™ product submission for FDA clearance in the very near future. We are also very pleased with the rapid progress in getting our core product, the AIMIGo™ containing 3D vector ECG collection device prepared for FDA submission in Q4 of this year,” said Branislav Vajdic, PhD, Chief Executive Officer and Founder of HeartBeam. “We continue to have strong conviction in our HeartBeam AIMI software platform technology and AIMIGo, our end-to-end telemedicine solution, and their potential to offer more accurate heart attack detection to expedite treatment.

“We were pleased by the progress our team has made over the past quarter, highlighted by our decision to expand the addressable patient population for our HeartBeam AIMI platform technology by including unstable angina as a diagnosis for analysis. In evaluating the ECG database for the clinical validation of our platform technology, we discovered a significant portion of consecutive patients fell into the category of unstable angina, a serious cardiac condition. Patients with unstable angina may have subtle electrical changes brought on by ischemia without definitive injury to the cardiac tissue. The expanded scope of the clinical validation study will provide access to a broader patient population for our technology once cleared by the FDA. Due to this decision, we expect to file a 510K with the full data set for clinical validation on or about August 15, 2022, and it does not affect the timeline for 510K submission of AIMIGo. In addition, we recently acquired the source code access for the HeartBeam branded version of the FDA Registered LIVMOR Portal, which will help us meet our schedule for FDA submissions and development of our software solutions in-house, led by our new Chief Technology Officer and his team.”

Dr. Vajdic continued, “Looking ahead, our commercialization path is on track with our AIMIGo 3D vector ECG product expected to be ready for FDA submission in Q4 of this year, along with the 510K filing in the coming days for HeartBeam AIMI. We recently announced the appointment of Chief Technology Officer, Ken Persen, whose deep knowledge of cardiovascular technologies, combined with industry insights, will be hugely important for continued development and evolution of HeartBeam’s technology. Our commercial team has continued to engage in positive discussions with strategic institutions, including academic centers, regional healthcare systems, and regional community hospital systems. Finally, we remain confident in our anticipated upcoming product milestones and believe we have sufficient resources to advance our programs through multiple value-inflection points towards commercialization. We look forward to providing updates on our progress in the months ahead.”

Anticipated Milestones

• HeartBeam AIMI Platform (for the Emergency Department)
  • Development of FDA-Ready Product - Q2 2022
  • FDA Study Completed – Q3 2022
  • FDA Submission – Q3 2022
  • FDA Clearance – Q4 2022
  • Limited Market Release – Q4 2022
  • Product Launch – Q1 2023

• HeartBeam AIMIGo Device (for 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

Second Quarter 2022 Financial Results

Research and development expenses for the second quarter of 2022 were $1.7 million, compared to $25,000 for the second quarter of 2021.

General and administrative expenses for the second quarter of 2022 were $1.8 million compared to $312,000 for the second quarter of 2021.

Net loss for the second quarter of 2022 was $3.5 million, compared to a net loss of $0.9 million for the second quarter of 2021.

Cash totaled $9.3 million as of June 30, 2022, compared to $13.2 million as of December 31, 2021.

Second 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, August 11, 2022
Time:					4:30 p.m. Eastern time (1:30 p.m. Pacific time)
Dial-in:					1-888-999-6281
International Dial-in:					1-848-280-6550
Conference Code:					3684645
Webcast:					https://viavid.webcasts.com/starthere.jsp?ei=1561275&tp_key=9fce20782b

A telephone replay will be available approximately two hours after the call and will run through November 11, 2022, by dialing 1-844-512-2921 from the U.S., or 1-412-317-6671 from international locations, and entering replay pin number: 151369. 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 in 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 (Unaudited)
(In thousands, except share data)
	June 30, 2022				December 31, 2021
Assets
Current Assets:
Cash and cash equivalents	$	9,274			$	13,192
Prepaid expenses and other assets		464				806
Total Assets	$	9,738			$	13,998
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable and accrued expenses (includes related party $1 for each period respectively)		770				588
Total Liabilities		770				588
Commitments and contingencies (Note 7)
Stockholders’ Equity
Common stock - $0.0001 par value; 20,000,000 shares authorized; 7,982,008 and 7,809,912 shares issued and outstanding at June 30, 2022 and December 31, 2021		1				1
Additional paid in capital		23,862				22,633
Accumulated deficit		(14,895	)			(9,224	)
Total Stockholders’ Equity	$	8,968			$	13,410
Total Liabilities and Stockholders’ Equity	$	9,738			$	13,998

HEARTBEAM, INC.
Statements of Operations (Unaudited)
(In thousands, except share and per share data)
	Three months ended June 30,								Six months ended June 30,
		2022				2021				2022				2021
Operating Expenses:
General and administrative	$	1,793			$	312			$	3,208			$	446
Research and development		1,742				25				2,475				54
Total operating expenses		3,535				337				5,683				500
Loss from operations		(3,535	)			(337	)			(5,683	)			(500	)
Other Income (Expense)
Interest income (expense)		10				(608	)			12				(677	)
Other income		—				—				—				22
Total other income (expense)		10				(608	)			12				(655	)
Loss before provision for income taxes	$	(3,525	)		$	(945	)		$	(5,671	)		$	(1,155	)
Income tax provision	$	—			$	—			$	—			$	—
Net Loss	$	(3,525	)		$	(945	)		$	(5,671	)		$	(1,155	)
Net loss per share, basic and diluted	$	(0.43	)		$	(0.26	)		$	(0.70	)		$	(0.31	)
Weighted average common shares outstanding, basic and diluted		8,145,967				3,699,762				8,092,237				3,706,550

HEARTBEAM, INC.
Statements of Cash Flows (Unaudited)
(In thousands)
	Six months ended June 30,
		2022				2021
Cash Flows From Operating Activities
Net loss	$	(5,671	)		$	(1,155	)
Adjustments to reconcile net loss to net cash used in operating activities
Accretion expense, convertible notes		—				531
Non-cash interest expense		—				147
Stock-based compensation expense		423				32
PPP loan forgiveness		—				(22	)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		342				(29	)
Accounts payable and accrued expenses		638				72
Net cash used in operating activities		(4,268	)			(424	)
Cash Flows From Financing Activities
Proceeds from sale of equity		348				—
Proceeds from exercise of stock options		2				—
Proceeds from issuance of convertible notes		—				865
Net cash provided by financing activities		350				865
Net (decrease) increase in cash		(3,918	)			441
Cash and Cash Equivalents – Beginning of period		13,192				24
Cash and Cash Equivalents – Ending of period	$	9,274			$	465
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			$	—
Conversion of short-term notes to convertible notes	$	—			$	1,644

 

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Media and Investor Relations Contact:

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Executive Vice President

MZ North America

Direct: 949-491-8235

BEAT@mzgroup.us

www.mzgroup.us

Source: HeartBeam, Inc.

FAQ

What are HeartBeam's expected FDA submission dates for its products?

HeartBeam expects to submit its HeartBeam AIMI™ software platform for FDA clearance on or around August 15, 2022, and its AIMIGo™ telehealth solution in Q4 2022.

What was HeartBeam's net loss for Q2 2022?

HeartBeam reported a net loss of $3.5 million for the second quarter of 2022, compared to a net loss of $0.9 million in Q2 2021.

How much cash did HeartBeam have at the end of Q2 2022?

As of June 30, 2022, HeartBeam had cash reserves totaling $9.3 million.

What expansion did HeartBeam make in its patient population?

HeartBeam expanded its addressable patient population to include unstable angina to enhance its HeartBeam AIMI platform clinical validation study.