HeartBeam, Inc. (NASDAQ: BEAT), a cardiac technology company that has developed the first and only credit card-size 3D-vector electrocardiogram (VECG) platform for patient use at home, allowing for the creation of rich data for AI, has reported its financial and operational results for the third quarter ended September 30, 2023.
Third Quarter and Subsequent 2023 Operational Highlights
- Announced the publication, in Journal of American College of Cardiology (“JACC”): Advances of a foundational study demonstrating the ability of HeartBeam’s VECG technology platform to detect the presence of coronary artery occlusions.
- Appointed Richa Gujarati as Senior Vice President, Product; Pooja Chatterjee as Vice President, Clinical; and Deborah Castillo, PhD, as Vice President of Regulatory Affairs, significantly bolstering the senior management team.
- Appointed Michael R. Jaff, DO, a renowned vascular physician and researcher bringing a wealth of clinical and industry experience to the Board of Directors.
- Expanded its Scientific Advisory Board (SAB) to include several leading cardiologists: Charles L. Brown III, MD; Tony Das, MD; Robert Harrington, MD; Campbell Rogers, MD; and Niraj Varma, MD, Ph.D.
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Made steady progress toward key AIMIGo™ VECG Device Clinical and Regulatory Milestones.
- Received and responded to questions from FDA on the initial AIMIGo 510(k) submission, which is focused on the system hardware.
- Held a pre-submission meeting with FDA on the second AIMIGo 510(k) submission, which is focused on the algorithms that synthesize a 12L ECG from the AIMIGo device. This application will be submitted after the initial clearance that is focusing on AIMIGo hardware. The emphasis of the pre-submission meeting was on the design of the clinical study that will demonstrate the performance of our synthesized 12L ECG in relation to standard 12L ECGs.
- The US Patent and Trademark Office granted a third patent for the 12-Lead Extended Wear Patch for detecting heart attacks and complex cardiac arrythmias.
- Cash and cash equivalents totaled approximately $19.2 million as of September 30, 2023, enabling the Company to execute on upcoming clinical and regulatory milestones. Projected cash runway goes into 2025.
Management Commentary
“During the third quarter of 2023 we significantly enhanced the HeartBeam team, continued to make steady progress toward upcoming clinical and regulatory milestones, and validated the potential of our VECG technology platform,” said Branislav Vajdic, PhD, Chief Executive Officer and Founder of HeartBeam. “Having respected industry executives in place is the cornerstone to successful clinical development and commercialization of our ambulatory VECG products, and we were privileged to welcome several experienced leaders in the last several months. Taken together, we believe that these new appointments, along with our full team’s collective expertise, vision, and dedication, will enable the timely delivery of our ambulatory VECG products to market, which are our key future value drivers.
“We also strengthened our Board with the appointment of respected industry executive Michael R. Jaff, DO, Chief Medical Officer and Vice President of Clinical Affairs, Technology and Innovation of the Peripheral Interventions division at Boston Scientific Corporation. Most recently we added five distinguished physicians to our Scientific Advisory Board, who will provide expertise in interventional cardiology, electrophysiology, clinical research, and new technologies.
“We recently announced the publication in JACC: Advances, of a landmark peer-reviewed study based on our novel VECG technology. This is an excellent validation of the technology and underscores its unique design benefits. The study demonstrates the potential for an easy-to-use patient-held device to be employed in the detection of heart attacks at home and deliver comparable results to that available from a 12-lead electrocardiogram (12L ECG) in a medical facility. By personalizing AIMIGo, combining the novel VECG approach with a system that incorporates a patient’s baseline signal, our technology was shown to detect coronary occlusions with an accuracy of almost 40% better than a 12L ECG when no baseline is readily available.
“We are pleased with the ongoing advancement toward several clinical and regulatory milestones for the HeartBeam AIMIGo VECG device, including active discussions with FDA that are progressing well. The product and regulatory efforts include first obtaining an FDA 510(k) clearance for the HeartBeam AIMIGo VECG device. We submitted this application to the FDA in May 2023. This will be followed by a second FDA application on the system’s ability to synthesize a 12L ECG. We continue to expect the product will be ready for limited market release during the second half of 2024.
“We ended the third quarter of 2023 with approximately $19.2 million in cash and cash equivalents, and believe we are in a strong position as we carefully manage spending to extend our runway. Earlier in the year we closed a $26.5 million in common stock-only financing, which we believe will fund our operations into early 2025. We look forward to providing updates on our progress in the months ahead,” concluded Dr. Vajdic.
Third Quarter 2023 Financial Results
Research and development expenses for the third quarter of 2023 were $1.6 million, compared to $1.6 million for the third quarter of 2022.
General and administrative expenses for the third quarter of 2023 were $2.1 million compared to $2.0 million for the third quarter of 2022.
Net loss for the third quarter of 2023 was $3.5 million, compared to a net loss of $3.6 million for the third quarter of 2022.
Cash and cash equivalents totaled approximately $19.2 million as of September 30, 2023, compared to $3.6 million of Cash and cash equivalents as of December 31, 2022. In May 2023, the Company completed the sale of Common Stock with gross proceeds of $26.5 million. Net cash used in operations was approximately $2.1 million this quarter.
Third Quarter 2023 Results Conference Call
HeartBeam CEO and Founder Branislav Vajdic, PhD, President Robert Eno, and CFO Richard Brounstein 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:
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Date: |
Tuesday, November 14, 2023 |
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Time: |
4:30 p.m. Eastern time (1:30 p.m. Pacific time) |
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Dial-in: |
1-877-704-4453 |
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International Dial-in: |
1-201-389-0920 |
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Conference Code: |
13741784 |
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Webcast: |
https://viavid.webcasts.com/starthere.jsp?ei=1637601&tp_key=06cb7fdae7 |
A telephone replay will be available approximately two hours after the call and will run through February 14, 2023, by dialing 1-844-512-2921 from the U.S., or 1-412-317-6671 from international locations, and entering replay pin number: 13741784. 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 cardiac technology company that has developed the first and only 3D-vector ECG platform intended for patient use at home. By applying a suite of proprietary algorithms to simplify vector electrocardiography (VECG), the HeartBeam platform enables patients and their clinicians to assess their cardiac symptoms quickly and easily, so care can be expedited, if required. HeartBeam AIMIGo™ is the first and only credit card-sized 12-lead output ECG device coupled with a smart phone app and cloud-based diagnostic software system to facilitate remote evaluation of cardiac symptoms. By collecting 3D signals of the heart’s electrical activity, HeartBeam AIMIGo has the potential to provide unparalleled data for the development of AI algorithms. HeartBeam AIMIGo has not yet been cleared by the US Food and Drug Administration (FDA) for marketing in the USA or other geographies. For more 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 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.
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HEARTBEAM, INC. |
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Condensed Balance Sheets (Unaudited) |
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(In thousands, except share data) |
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September 30, |
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December 31, |
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Assets |
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Current Assets: |
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|
|
||||
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Cash and cash equivalents |
$ |
19,184 |
|
|
$ |
3,594 |
|
|
Prepaid expenses and other current assets |
|
295 |
|
|
|
445 |
|
|
Total Current Assets |
$ |
19,479 |
|
|
$ |
4,039 |
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|
|
|
|
|
||||
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Property and equipment, net |
|
144 |
|
|
|
— |
|
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Other assets |
|
25 |
|
|
|
— |
|
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Total Assets |
$ |
19,648 |
|
|
$ |
4,039 |
|
|
|
|
|
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||||
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Liabilities and Stockholders’ Equity |
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|
|
||||
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Current Liabilities: |
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|
|
||||
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Accounts payable and accrued expenses (includes related party $2) |
|
1,019 |
|
|
|
1,665 |
|
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Total Liabilities |
|
1,019 |
|
|
|
1,665 |
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|
|
|
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||||
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Commitments |
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Stockholders’ Equity |
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||||
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Preferred stock – $0.0001 par value; 10,000,000 authorized; 0 shares outstanding at September 30, 2023 and December 31, 2022 |
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— |
|
|
|
— |
|
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Common stock – $0.0001 par value; 100,000,000 shares authorized; 26,325,282 and 8,009,743 shares issued and outstanding at September 30, 2023 and December 31, 2022 |
|
3 |
|
|
|
1 |
|
|
Additional paid in capital |
|
51,572 |
|
|
|
24,559 |
|
|
Accumulated deficit |
|
(32,946 |
) |
|
|
(22,186 |
) |
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Total Stockholders’ Equity |
$ |
18,629 |
|
|
$ |
2,374 |
|
|
|
|
|
|
||||
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Total Liabilities and Stockholders’ Equity |
$ |
19,648 |
|
|
$ |
4,039 |
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HEARTBEAM, INC. |
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Condensed Statements of Operations (Unaudited) |
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(In thousands, except share and per share data) |
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Three months ended September 30, |
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Nine months ended September 30, |
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2023 |
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2022 |
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|
|
2023 |
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|
|
2022 |
|
|
Operating Expenses: |
|
|
|
|
|
|
|
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General and administrative |
$ |
2,114 |
|
|
$ |
2,048 |
|
|
$ |
6,417 |
|
|
$ |
5,256 |
|
|
Research and development |
|
1,623 |
|
|
|
1,562 |
|
|
|
4,788 |
|
|
|
4,036 |
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Total operating expenses |
|
3,737 |
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|
|
3,610 |
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|
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11,205 |
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|
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9,292 |
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|
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Loss from operations |
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(3,737 |
) |
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(3,610 |
) |
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(11,205 |
) |
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(9,292 |
) |
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|
|
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|
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Other Income |
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|
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|
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Interest income |
|
267 |
|
|
|
28 |
|
|
|
445 |
|
|
|
39 |
|
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Other Income |
|
— |
|
|
|
3 |
|
|
|
— |
|
|
|
3 |
|
|
Total other income |
|
267 |
|
|
|
31 |
|
|
|
445 |
|
|
|
42 |
|
|
|
|
|
|
|
|
|
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Loss before provision for income taxes |
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(3,470 |
) |
|
|
(3,579 |
) |
|
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(10,760 |
) |
|
|
(9,250 |
) |
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|
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|
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Income tax provision |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
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|
|
|
|
|
|
|
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Net Loss |
$ |
(3,470 |
) |
|
$ |
(3,579 |
) |
|
$ |
(10,760 |
) |
|
$ |
(9,250 |
) |
|
|
|
|
|
|
|
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Net loss per share, basic and diluted |
$ |
(0.13 |
) |
|
$ |
(0.44 |
) |
|
$ |
(0.59 |
) |
|
$ |
(1.14 |
) |
|
|
|
|
|
|
|
|
|
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Weighted average common shares outstanding, basic and diluted |
|
26,449,168 |
|
|
|
8,147,024 |
|
|
|
18,252,654 |
|
|
|
8,107,359 |
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HEARTBEAM, INC. |
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Condensed Statements of Cash Flows (Unaudited) |
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(In thousands) |
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Nine Months ended September 30, |
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|
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2023 |
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2022 |
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Cash Flows From Operating Activities |
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|
|
||||
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Net loss |
$ |
(10,760 |
) |
|
$ |
(9,250 |
) |
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Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
||||
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Stock-based compensation expense |
|
2,021 |
|
|
|
774 |
|
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Changes in operating assets and liabilities: |
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|
|
||||
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Prepaid expenses and other current assets |
|
150 |
|
|
|
683 |
|
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Accounts payable and accrued expenses |
|
(646 |
) |
|
|
800 |
|
|
Net cash used in operating activities |
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(9,235 |
) |
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|
(6,993 |
) |
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Cash Flows From Investing Activities |
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Purchase of property and equipment |
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(144 |
) |
|
|
— |
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Net cash used in investing activities |
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(144 |
) |
|
|
— |
|
|
|
|
|
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Cash Flows From Financing Activities |
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||||
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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 |
|
|
|
|
|
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Net increase (decrease) in cash and restricted cash |
|
15,615 |
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|
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(6,643 |
) |
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Cash, cash equivalents and restricted cash – beginning of period |
|
3,594 |
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|
|
13,192 |
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|
|
|
|
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Cash, cash equivalents and restricted cash – at end of period |
$ |
19,209 |
|
|
$ |
6,549 |
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|
|
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Supplemental Disclosures of Cash Flow Information: |
|
|
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Taxes paid |
$ |
— |
|
|
$ |
— |
|
|
Interest paid |
|
— |
|
|
|
— |
|
|
|
|
|
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Supplemental Disclosures of Non-cash Flow Information: |
|
|
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||||
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Issuance of common stock and warrants to settle accrued expenses |
|
— |
|
|
|
456 |
|
|
|
|
|
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Reconciliation of cash, cash equivalents and restricted cash: |
|
|
|
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Cash and cash equivalents |
|
19,184 |
|
|
|
6,549 |
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|
Restricted cash (included in other assets) |
|
25 |
|
|
|
— |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20231114221434/en/