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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2024
or
☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from ___________ to ___________
Commission File Number: 001-41060
HEARTBEAM, INC.
(Exact Name of Registrant as Specified in its Charter)
Delaware47-4881450
State or Other Jurisdiction of
Incorporation or Organization
I.R.S. Employer
Identification No.
2118 Walsh Avenue, Suite 210
Santa Clara, CA
95050
Address of Principal Executive OfficesZip Code
(408) 899-4443
Registrant’s Telephone Number, Including Area Code
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common StockBEATNASDAQ
WarrantsBEATWNASDAQ
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer ☐
Accelerated filer ☐
Non-accelerated filer ☒
Smaller reporting company ☒
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
Number of shares of common stock outstanding as of November 5, 2024 was 26,665,470.

HEARTBEAM, INC.
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (“Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (“Exchange Act”). In particular, statements contained in this Quarterly Report on Form 10-Q, including but not limited to, statements regarding the sufficiency of our cash, our ability to finance our operations and business initiatives and obtain funding for such activities; our future results of operations and financial position, business strategy and plan prospects, or costs and objectives of management for future acquisitions, are forward looking statements. These forward-looking statements relate to our future plans, objectives, expectations and intentions and may be identified by words such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “intends,” ’‘targets,” “projects,” “contemplates,” ’‘believes,” “seeks,” “goals,” “estimates,” ’‘predicts,” ’‘potential” and “continue” or similar words. Readers are cautioned that these forward-looking statements are based on our current beliefs, expectations and assumptions and are subject to risks, uncertainties, and assumptions that are difficult to predict, including those identified below, under Part II, Item lA. “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q and those risks identified under Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2023 filed with the Securities and Exchange Commission on March 20, 2024. Therefore, actual results may differ materially and adversely from those expressed, projected or implied in any forward-looking statements. We undertake no obligation to revise or update any forward-looking statements for any reason.

NOTE REGARDING COMPANY REFERENCES
Throughout this Quarterly Report on Form 10-Q, “HeartBeam,” “Company,” “we,” “us” and “our” refer to HeartBeam, Inc.

FORM 10-Q
TABLE OF CONTENTS

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PART I - FINANCIAL INFORMATION
Item 1. Condensed Unaudited Financial Statements
HEARTBEAM, INC.
Condensed Balance Sheets (Unaudited)
(In thousands, except share data)
September 30,
2024		December 31,
2023
Assets
Current Assets:
Cash and cash equivalents
$5,768 $16,189 
Prepaid expenses and other current assets
376 636 
Total Current Assets6,144 16,825 
Property and equipment, net457 256 
Other assets56 50 
Total Assets$6,657 $17,131 
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable and accrued expenses (includes related party $5 and $2, respectively)
$1,856 $1,194 
Total Current Liabilities1,856 1,194 
Total Liabilities
1,856 1,194 
Commitments (Note 7)


Stockholders’ Equity
Preferred stock - $0.0001 par value; 10,000,000 authorized; 0 shares outstanding at September 30, 2024 and December 31, 2023
— — 
Common stock - $0.0001 par value 100,000,000 shares authorized; 26,594,928 and 26,329,032 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively
3 3 
Additional paid in capital
56,164 52,759 
Accumulated deficit
(51,366)(36,825)
Total Stockholders’ Equity
4,801 15,937 
Total Liabilities and Stockholders’ Equity
$6,657 $17,131 
See accompanying notes to the condensed unaudited financial statements
1
HEARTBEAM, INC.
Condensed Statements of Operations (Unaudited)
(In thousands, except share and per share data)
Three months ended September 30,Nine Months ended September 30,
2024202320242023
Operating Expenses:
General and administrative
$2,176 $2,114 $6,778 $6,417 
Research and development
2,893 1,623 8,165 4,788 
Total operating expenses
5,069 3,737 14,943 11,205 
Loss from operations(5,069)(3,737)(14,943)(11,205)
Other Income and (Expense)
Interest income96 267 408 445 
Other expense(6)— (6)— 
Total other income 90 267 402 445 
Loss before provision for income taxes(4,979)(3,470)(14,541)(10,760)
Income tax provision— — — — 
Net Loss$(4,979)$(3,470)$(14,541)$(10,760)
Net loss per share, basic and diluted$(0.19)$(0.13)$(0.55)$(0.59)
Weighted average common shares outstanding, basic and diluted26,752,297 26,449,168 26,610,760 18,252,654 
See accompanying notes to the condensed unaudited financial statements
2
HEARTBEAM, INC.
Condensed Statement of Changes in Stockholders’ Equity (Unaudited)
(In thousands, except share data)
Three months ended September 30, 2024
Common StockAdditional
Paid-in
Capital		Accumulated
Deficit		Total
Stockholders'
Equity
SharesAmount
Balance - July 1, 202426,562,111 $3 $55,090 $(46,387)$8,706 
Stock based compensation expense— — 1,053 — 1,053 
Stock issuance upon exercise of stock options32,817 — 21 — 21 
Net loss— — — (4,979)(4,979)
Balance – September 30, 2024
26,594,928 $3 $56,164 $(51,366)$4,801 
Three months ended September 30, 2023
Common StockAdditional
Paid-in
Capital		Accumulated
Deficit		Total
Stockholders'
Equity
SharesAmount
Balance - July 1, 202325,990,516 $3 $50,535 $(29,476)$21,062 
Stock based compensation expense— — 926 — 926 
Stock issuance upon exercise of stock options92,046 — 111 — 111 
Stock issuance upon vesting of restricted stock units242,720 — — — — 
Net loss— — — (3,470)(3,470)
Balance – September 30, 202326,325,282 $3 $51,572 $(32,946)$18,629 








3
Nine months ended September 30, 2024
Common StockAdditional
Paid-in
Capital		Accumulated
Deficit		Total
Stockholders'
Equity
SharesAmount
Balance - January 1, 202426,329,032 $3 $52,759 $(36,825)$15,937 
Stock based compensation expense— — 3,300 — 3,300 
Sale of Common Stock under ATM, net of issuance costs50,000 — 76 — 76 
Stock issuance upon exercise of stock options38,069 — 29 — 29 
Stock issuance upon vesting of restricted stock units177,827 — — — — 
Net loss— — — (14,541)(14,541)
Balance - September 30, 202426,594,928 $3 $56,164 $(51,366)$4,801 
Nine months ended September 30, 2023
Common StockAdditional
Paid-in
Capital		Accumulated
Deficit		Total
Stockholders'
Equity
SharesAmount
Balance - January 1, 20238,009,743 $1 $24,559 $(22,186)$2,374 
Stock based compensation expense— — 2,021 — 2,021 
Sale of Common Stock, net of issuance costs17,872,955 2 24,762 — 24,764 
Stock issuance upon exercise of stock options180,072 — 214 — 214 
Stock issuance upon vesting of restricted stock units255,220 — — — — 
Stock issuance upon exercise of warrants7,292 — 16 — 16 
Net loss— — — (10,760)(10,760)
Balance – September 30, 202326,325,282 $3 $51,572 $(32,946)$18,629 
See accompanying notes to the condensed unaudited financial statements
4
HEARTBEAM, INC.
Condensed Statements of Cash Flows (Unaudited)
(In thousands)
Nine Months ended September 30,
20242023
Cash Flows From Operating Activities
Net loss$(14,541)$(10,760)
Adjustments to reconcile net loss to net cash used in operating activities

Stock based compensation expense3,300 2,021 
Changes in operating assets and liabilities:
Prepaid expenses and other current assets260 150 
Accounts payable and accrued expenses662 (646)
Net cash used in operating activities(10,319)(9,235)

Cash Flows From Investing Activities
Purchase of property and equipment(201)(144)
Net cash used in investing activities(201)(144)
Cash Flows From Financing Activities
Proceeds from sale of equity, net of issuance costs76 24,764 
Proceeds from exercise of stock options29 214 
Proceeds from exercise of warrants— 16 
Net cash provided by financing activities105 24,994 
Net increase (decrease) in cash and restricted cash(10,415)15,615 
Cash, cash equivalents and restricted cash – Beginning of period16,239 3,594 
Cash, cash equivalents and restricted cash – Ending of period$5,824 $19,209 
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents$5,768 $19,184 
Restricted cash (included in other assets)5625 
Total cash, cash equivalents and restricted cash$5,824 $19,209 
See accompanying notes to the condensed unaudited financial statements
5
HEARTBEAM, INC.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
NOTE 1 – ORGANIZATION AND OPERATIONS
HeartBeam, Inc. (“HeartBeam” or the “Company”) is a cardiac technology company focusing on developing and commercializing higher resolution ambulatory Electrocardiogram (“ECG”) solutions that enable the detection and monitoring of cardiac disease outside a healthcare facility setting. The Company’s ability to develop higher resolution ECG solutions is achieved through the development of the Company’s proprietary and patented Vector Electrocardiography (“VECG”) technology platform. HeartBeam’s VECG is capable of developing three-dimensional (3D) representations of cardiac electrical activity by displaying the spatial locations of ECG waveforms that demonstrated in early studies to deliver diagnostic capability equal or superior to traditional hospital-based ECG systems.

The Company has validated this technology and is seeking U.S. Food and Drug Administration (“FDA”) clearance of its initial telehealth products. The Company filed a 510(k) submission in 2023 for its initial product, a patient-held VECG device. With a planned second submission, this product will become an ambulatory device, carried by patients, which can synthesize a 12L ECG for physician review.

The Company was incorporated in 2015 as a Delaware corporation. The Company operates as one segment and its operations are based in Santa Clara, California.

NOTE 2 – GOING CONCERN AND OTHER UNCERTAINTIES

The Company is subject to a number of risks similar to those of early stage medical device companies, including dependence on key individuals and products, the inherent uncertainties with regulatory approvals, the difficulties inherent in the development of a commercial market, the potential need to obtain additional capital, competition from larger companies, other technology companies and other technologies.

The Company has incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception. As of September 30, 2024 the Company has a cash and cash equivalents balance of approximately $5.8 million. Based on its current business plan assumptions and expected cash burn rate, the Company believes that the existing cash is insufficient to fund operations for the next twelve months following the issuance of these financial statements. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern.

Therefore, the Company’s continued operations will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships until sufficient revenue can be generated to achieve positive cash flow from operations. The Company expects no material commercial revenue in 2024.

The Company continues to maintain strong financial discipline as it achieves critical R&D, clinical and regulatory milestones in advance of commercialization. Management believes the continued achievement of these milestones will provide the Company the ability to raise additional capital. Management can provide no assurance that such financing or strategic relationships will be available on acceptable terms, or at all, which would likely have a material adverse effect on the Company and its financial statements.

On May 2, 2024, the Company entered into a Sales Agreement (“PV Sales Agreement”) with Public Ventures, LLC, as sales agent (“Public Ventures”), pursuant to which the Company may sell up to an aggregate of approximately $17 million of shares of the Company’s common stock. There were 50,000 shares issued under the At The Market (“ATM”) during the nine months ended September 30, 2024. As of September 30, 2024, there was approximately $16.9 million available for issuance under the ATM.

The accompanying unaudited condensed financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that may result should the Company be unable to continue as a going concern.

6
NOTE 3 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

BASIS OF PRESENTATION

The accompanying condensed unaudited financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America ("US GAAP") and in conformity with the instructions on Form 10-Q and Rule 8-03 of Regulation S-X and the related rules and regulations of the Securities and Exchange Commission (“SEC”) and have been prepared on a basis which assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. In the opinion of management, the unaudited interim condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results of operations for the periods presented. The interim operating results are not necessarily indicative of results that may be expected for any subsequent period. The accompanying condensed unaudited financial statements should be read in conjunction with the Company’s audited annual financial statements and notes thereto included in the Company’s Form 10-K filed with the SEC on March 20, 2024 (“2023 Annual Report”).

CASH, CASH EQUIVALENTS AND RESTRICTED CASH

The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash deposits. The Company maintains its cash in institutions insured by the Federal Deposit Insurance Corporation (“FDIC”) and has cash balances in accounts which exceed the federally insured limits as of September 30, 2024 and December 31, 2023. The Company has made a deposit to the bank for their credit cards in the amount of $56,000 and $50,000 and is classified as restricted cash included in other assets as of September 30, 2024, and December 31, 2023, respectively.

USE OF ESTIMATES

The preparation of financial statements in conformity with US GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be based on amounts that differ from those estimates.

PROPERTY AND EQUIPMENT, NET

Property and equipment are stated at cost less accumulated depreciation. Depreciation of property and equipment is calculated using the straight-line method over the estimated useful lives of the assets. The Company regularly evaluates the estimated remaining useful lives of the Company’s property and equipment, net, to determine whether events or changes in circumstances warrant a revision to the remaining period of depreciation. Maintenance and repairs are expensed as incurred.

During the three months ended September 30, 2024, the Company has capitalized tools amounting to $52,200, which is being depreciated based on useful life of 7 years. Depreciation and amortization expense for the three months ended September 30, 2024 was nominal. As of September 30, 2024, property and equipment, net represents machinery and equipment of $51,600 and construction-in-progress related to tooling development that has not been placed into service is amounting to $405,000 and $256,000 as of September 30, 2024, and December 31, 2023, respectively. Construction-in-progress amounts are not subject to depreciation as such assets are not yet available for their intended use.

NET LOSS PER COMMON SHARE

Basic net loss per share excludes the effect of dilution and is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding.

Diluted net loss per share is computed by giving effect to all potential shares of common stock, including stock options and warrants to the extent dilutive. Basic net loss per share was the same as diluted net loss per share for the three and nine months ended September 30, 2024 and 2023 as the inclusion of all potential common shares outstanding would have an anti-dilutive effect.

7
In accordance with ASC 260-10-45-13, exercisable penny options are included in the calculation of weighted average basic and diluted earnings per share. Penny options of 178,533 and 176,105 have been included in the calculation of weighted average basic and diluted earnings per share for the three and nine months ended September 30, 2024 and September 30, 2023, respectively.

The following is a summary of awards outstanding as of September 30, 2024 and 2023, which are not included in the computation of basic and diluted weighted average shares:
Three and Nine months ended
September 30,
20242023
Stock options (excluding exercisable penny stock options)7,244,175 4,782,020 
Restricted stock units283,411 221,631 
Warrants5,152,397 5,152,397 
Total12,679,983 10,156,048 

RECENTLY ISSUED ACCOUNTING STANDARDS

Not Yet Adopted as of September 30, 2024:

In November 2023, the Financial Standards Accounting Board (FASB) issued Accounting Standards Update (ASU) 2023-07 "Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures" which expands annual and interim disclosure requirements for reportable segments, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 is effective for the Company’s annual periods beginning January 1, 2024, and for interim periods beginning January 1, 2025, with early adoption permitted. The Company is evaluating the disclosure impact of the updated standard on the Company’s financial statement disclosures.

In December 2023, the FASB issued ASU 2023-09 "Income Taxes (Topics 740): Improvements to Income Tax Disclosures" to expand the disclosure requirements for income taxes, specifically related to the rate reconciliation and income taxes paid. ASU 2023-09 is effective for the Company’s annual periods beginning January 1, 2025, with early adoption permitted. The Company is currently evaluating the potential effect that the updated standard will have on the Company’s financial statement disclosures.

In March 2024, the FASB issued ASU 2024-02 “Codification Improvements – Amendments to Remove References to the Concepts Statements.” This amendments to the Codification that remove references to various Concepts Statement. The amendments in this update are effective for public business entities for fiscal years beginning after December 15, 2024. Early application of the amendments in this update is permitted for all entities, for any fiscal year or interim period for which financial statements have not yet been issued (or made available for issuance). If an entity adopts the amendments in an interim period, it must adopt them as of the beginning of the fiscal year that includes that interim period. The Company is currently evaluating the impact that the adoption of this standard will have on the Company’s financial statement disclosures.

NOTE 4 – STOCKHOLDERS’ EQUITY

WARRANTS

The following is a summary of warrant activity during the nine months ended September 30, 2024:
Number of
shares		Weighted
average exercise
price		Weighted
average
remaining life (years)		Aggregate
intrinsic value
(in thousands)
Outstanding and exercisable - December 31, 2023
5,152,397 $4.71 3.35$792 
Exercised— — — — 
Expired— — — — 
Outstanding and exercisable – September 30, 2024
5,152,397 $4.71 2.59$742 
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NOTE 5 – STOCK-BASED COMPENSATION

At the June 2024 annual stockholders’ meeting the 2022 Equity Incentive Plan was amended to increase the number of authorized shares from 5,900,000 shares to 8,900,000.
STOCK OPTIONS
The following is a summary of stock option activity during the nine months ended September 30, 2024:
Number of
options
outstanding		Weighted
average
exercise
price		Average
remaining
contractual life
(in years)		Aggregate
intrinsic value
(in thousands)
Outstanding – December 31, 2023
6,092,525 $2.22 8.7$2,945 
Options granted
1,435,000 2.32 
Options exercised
(38,069)0.77 
Options cancelled(66,748)3.54 
Outstanding – September 30, 2024
7,422,708 $2.24 8.6$2,826 
Exercisable – September 30, 2024
2,147,402 $1.96 7.5$1,534 
The Company estimates the fair values of stock options using the Black-Scholes option-pricing model on the date of grant. For the nine months ended September 30, 2024 and 2023, the assumptions used in the Black-Scholes option pricing model, which was used to estimate the grant date fair value per option, were as follows:

Nine Months ended September 30,
20242023
Weighted-average Black-Scholes option pricing model assumptions:
Volatility
125.33% - 128.85%
110.23% - 110.64%
Expected term (in years)
6.00 - 7.00
5.85 - 6.07
Risk-free rate
3.59% - 4.60%
3.54% - 3.95%
Expected dividend yield$— $— 
Weighted average grant date fair value per share
$1.81 - $2.48
$1.75 - $3.38

RESTRICTED STOCK UNITS
The following is a summary of RSU’s awards activity during the nine months ended September 30, 2024:
Nine Months ended September 30, 2024
Numbers of SharesWeighted Average Grant Date Fair value
Non-Vested at beginning of period217,881 $3.12 
Shares granted243,357 2.26 
Shares vested(177,827)3.13 
Non-vested at the end of period283,411 $2.38 
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STOCK BASED COMPENSATION

The following is a summary of stock-based compensation expense (rounded):
Three months ended September 30,Nine Months ended September 30,
2024202320242023
General and administrative
Stock options560,000 589,500 1,898,000 1,352,100 
RSU’s149,000 153,000 433,000 323,000 
Total general and administrative709,000 742,500 2,331,000 1,675,100 
Research and development
Stock options334,000 173,600 941,000 336,100 
  RSU’s 10,000 10,200 28,000 10,200 
Total research and development344,000 183,800 969,000 346,300 
Total1,053,000 926,300 3,300,000 2,021,400 

During the nine months ended 2023, the Company granted 2,208,000 options to various executives and employees. Sixty percent (60%) of these options vest based on FDA Clearance for marketing of HeartBeam’s synthesized 12L product and the remaining forty percent (40%) vest monthly over a period of 48 months.

The Company calculated the fair value for each of these grants using the Black-Scholes option pricing model and the performance-based options are expensed beginning from date of grant to the expected FDA clearance, which is based on management’s probability assessment performed on a quarterly basis.

As of September 30, 2024, total compensation cost not yet recognized related to unvested stock options and unvested RSUs was approximately $8.3 million and $0.5 million, respectively, which is expected to be recognized over a weighted-average period of 2.9 years and 0.85 years, respectively.

NOTE 6 – RELATED PARTY TRANSACTIONS

During the course of business, the Company obtains accounting services from CTRLCFO, a firm in which a prior executive of the Company had significant influence. On December 29, 2023, this executive, informed the Company of his plans to retire from his position as of February 1, 2024 and as such ceased to be a related party as of February 1, 2024. The Company had balances due to this firm amounting to approximately $2,000 as of December 31, 2023.

During April 2024, the Company entered into consulting agreement with one of the independent Board of Directors to provide business development consulting services. For these consulting services, the Company agreed to pay $5,000 per month as remuneration and granted 70,000 options to vest during over a period of 36 months. During the three and nine months ended September 30, 2024, the Company recognized $25,700 and $50,200, respectively related to these consulting services, which includes stock based compensation expense of $10,700 and $20,200, respectively.

NOTE 7 – COMMITMENTS

Lease Obligations

Prior to February 1, 2024, the Company was in a month-to-month lease agreement for its headquarters. The agreement was for an undefined term that could be cancelled at any time, given one month’s notice by either party. The Company’s monthly rent expense associated with this agreement was approximately $1,800. This headquarters lease was in the name of the Company’s Chief Executive Officer, and the cost was reimbursed monthly to CEO until January 31, 2024 when the Company terminated the month-to-month lease, and entered into a new lease in name of the Company with the same landlord. The new lease commenced on February 1, 2024, for initial period of 3 years. The Company performed an assessment and concluded that amount of operating lease right-of-use, or ROU assets was below the Company’s capitalization thresholds set in accordance with ASC 842. For the three and nine months ended September 30, 2024 rent was approximately $5,400 and $15,840, respectively. For the three and nine months ended September 30, 2023, rent expense was approximately $4,000 and $12,000, respectively.

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Professional Services Agreement

In March 2022, the Company entered into a professional services agreement with Triple Ring Technologies, Inc. (“TRT”), a co-development company, to assist in the design and development of the Company’s telehealth complete solution 3D vector ECG collection device for remote heart attack or MI monitoring. This agreement was followed by several amendments. The agreement with TRT includes a commitment totaling $1.7 million. For the three and nine months ended September 30, 2024, the Company has expensed approximately $0.1 million and $0.3 million, respectively. For the three and nine months ended September 30, 2023, the Company has expensed approximately $0.3 million and $0.8 million, respectively.

As of September 30, 2024, the Company has a remaining commitment of $0.1 million.

Clinical Research Organization

On March 8, 2024, the Company has entered into an agreement with Clinical Research Organization (CRO) to perform certain services related to project set up, clinical trial management and monitoring during next six months. As per terms of the agreement, the Company will pay CRO approximately $0.5 million for these services. Additionally, the Company has signed a Clinical Study Agreement with first of five sites to carry out the clinical study for which CRO will act as Company sponsor in relation to payment for these services. The total cost of the clinical trial including the CRO cost is expected to approximate $0.9 million. For the three months and nine months ended September 30, 2024, the Company has expensed $0.1 million and $0.7 million based on actual services performed by the CRO and clinical sites, of which $0.1 million was accrued as of September 30, 2024. As of September 30, 2024, the Company has a remaining commitment of $0.1 million.



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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following management’s discussion and analysis is intended as a review of significant factors affecting our financial condition and results of operations for the periods indicated. The discussion should be read in conjunction with our condensed unaudited financial statements and the notes presented herein included in this Form 10-Q and the audited financial statements and the other information set forth in the 2023 Form 10-K. When used, the words “believe,” “plan,” “intend,” “anticipate,” “target,” “estimate,” “expect” and the like, and/or future tense or conditional constructions (“will,” “may,” “could,” “should,” etc.), or similar expressions, identify certain of these forward-looking statements. In addition to historical information, the following Management’s Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements that involve risks and uncertainties including, but not limited to, those set forth below under “Risk Factors” and elsewhere herein, and those identified under Part I, Item 1A of our 2023 Form 10-K. Our actual results could differ significantly from those anticipated in these forward-looking statements as a result of certain factors discussed herein and any other periodic reports filed and to be filed with the Securities and Exchange Commission.

Overview

We are a medical technology company focused on transforming cardiac care through the power of personalized insights. Our aim is to deliver innovative, higher resolution ambulatory cardiac monitoring solutions that can be used by patients anywhere to enable the detection and monitoring of cardiac disease outside of a healthcare facility. Our ability to develop higher resolution Electrocardiogram (“ECG”) solutions is achieved through the development of our proprietary and patented Vector Electrocardiography (“VECG”) technology platform. Our VECG technology is capable of capturing 3D vector signals of the heart’s electrical activity and synthesizing a 12-Lead (“12L”) ECG from these signals. In early studies, our approach demonstrated equal or superior diagnostic capability than traditional hospital-based 12L ECG systems.

Our Products (“Product” or “Products”) require FDA clearance and have not been cleared for marketing.

We believe our Products and services will benefit many stakeholders, including patients, healthcare providers, and healthcare payors. We are developing our telehealth Product, (“the HeartBeam System”, previously referred to as “AIMIGo™”), to address the rapidly growing field of ambulatory cardiac health monitoring. The HeartBeam System is comprised of a credit card sized electrocardiogram device, a patient application, a physician portal, and powerful cloud-based algorithms. We believe that we are uniquely positioned to play a central role in ambulatory cardiac monitoring including high-risk Coronary Artery Disease (“CAD”) patients, because the initial studies have shown that our ischemia detection system may be more accurate than existing ambulatory monitoring solutions. CAD patients are at increased risk for a heart attack or Myocardial Infarction (“MI”).

To date, we have developed a working prototype for the HeartBeam System and have filed a 510(k) submission with the FDA. This submission is for the initial Product, a device which is a 3 lead (3L) X, Y, Z vector VECG. We are in the substantive review phase of answering questions posed by the FDA on this submission. We have clarified the information requested in meetings with FDA representatives and are finalizing our official responses. During the second half of 2024 we received additional questions from FDA, have provided answers and additional data, and are engaged in productive discussions to finalize the clearance. If cleared as anticipated, we believe this will be the first patient-held VECG device to be cleared by the FDA and this will be a major milestone for the company.

Following FDA clearance of the HeartBeam System, we plan to file a submission for the software algorithms that synthesize a 12L ECG from the HeartBeam System. We have held two pre-submission meetings with the FDA on this 12L synthesis submission. These meetings focused primarily on the performance goals of our clinical study that is designed to demonstrate the similarity between our synthesized 12L signal and the output of a standard 12L ECG for the intended use. Based on feedback from FDA and our clinical experts, we have designed a prospective multicenter pivotal study, the VALID-ECG Study for clinical validation of the HeartBeam 12 Lead ECG Synthesis Software for Arrhythmia Detection.

On June 20, 2024, we completed patient enrollment in the VALID-ECG Study. A total of 198 patients were enrolled from five clinical sites in the United States. The primary objective was to demonstrate the equivalence of ECG waveforms between the HeartBeam System Synthesized 12L ECG and Standard 12L ECG, recorded simultaneously in each subject, by assessing relevant ECG characteristics, i.e. intervals and amplitudes. Efforts were made to enroll patients with a diverse demographic profile reflective of the intended use population in the United States.

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We are currently analyzing the data and working on the other components of the second 510(k) application. We anticipate submitting this 510(k) application soon after receiving the initial FDA clearance. The result of these two 510(k) submissions, if cleared by the FDA as anticipated, will be an ambulatory device, carried by patients, which can synthesize a 12L ECG for physician review.

We continue to anticipate that our Early Access Program for the HeartBeam System will occur in coming months. This program will provide the company with valuable feedback on the user experience and functionality of the system in a real world setting. We do not anticipate that the HeartBeam System clearance will generate significant revenue before the 12L clearance.

We also have an active AI program underway. Our AI team includes 5 PhDs. The leadership has deep AI expertise, including prior positions at Apple, Microsoft and Google. We have acquired approximately one million 12L ECGs from various sources, a key element in our fast-paced AI development efforts.

We have developed initial deep learning algorithms, focused on the ability to detect various cardiac arrhythmias. HeartBeam has had data on its deep learning algorithm presented at two prestigious Electrophysiology conferences. Data were presented at the European Heart Rhythm Association in Berlin, Germany in April 2024 and at the Heart Rhythm Society, in Boston, MA in May 2024. We believe that, when combined with our Products, HeartBeam’s AI will provide additional value to patients and physicians in several ways, including:

•Providing automated classification of cardiac conditions, including common arrhythmias,
•Potentially enhancing user experience and simplify the onboarding process, and
•In the longer run, we believe that applying deep learning algorithms on top of the rich VECG data, especially with the longitudinal dataset from patients taking repeated readings, may result in unsurpassed predictive and diagnostic capabilities.

The custom software and hardware of our Products are classified as Class II medical devices by the FDA, running on an FDA registered Class I software platform. Premarket review and clearance by the FDA for Class II devices is generally accomplished through the 510(k) premarket notification process or De Novo process. Given the proposed intended use of our device, the 510(k) submission is expected to require clinical data to support FDA clearance.

A landmark clinical study on the HeartBeam technology was published in the August 2023 issue of the journal JACC: Advances. The publication, “Coronary Artery Occlusion Detection Using 3-Lead ECG System Suitable for Credit Card-Size Personal Device Integration” demonstrated that HeartBeam’s VECG technology detects the presence of a coronary occlusion, the cause of heart attacks, with the same accuracy as a standard 12L ECG.

The study showed that the automated analysis of the VECG and 12L ECG signals had similar performance in determining whether a coronary artery was occluded. Also in the study, the human interpretation of the 12L ECGs had significant intra- and inter-observer variability, which does not occur with automated readings. The study also showed that the presence of the “normal baseline” recording, a novel feature that is integral to HeartBeam’s VECG technology, dramatically improved the accuracy of interpretation, increasing the Area Under the Curve, a standard measure of diagnostic performance, from 0.72 to 0.95. This is particularly important since physicians who are analyzing 12L ECGs often do not have access to a normal baseline, implying that the HeartBeam system could outperform this approach.

The study was a collaboration of Harvard Medical School Faculty at Beth Israel Deaconess Medical Center in Boston, MA, and Clinical Center of Serbia in Belgrade.

As of September 30, 2024, we had 20 employees. We intend to hire or engage additional full-time professionals, employees, and / or consultants to align with our growth strategy. Although the market is highly competitive for attracting and retaining highly qualified professionals in our industry, we continue our endeavor to find such candidates for our Company. Our management team and additional personnel that we may hire in the future will be primarily responsible for executing and implementing growth opportunities, making tactical decisions related to our strategy and pursuing opportunities to invest in new technologies through strategic partnerships and acquisitions.



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Recent Developments

New and Existing Patent Assignments

Thus far in 2024, we have been granted two new U.S. patents:

•One patent covers apparatuses and methods that facilitate the comparison of cardiac signals over time for the automated or assisted detection of heart attacks. The other patent covers methods and apparatuses around HeartBeam’s wrist-based ECG system.

•We now have 17 issued patents worldwide, with 13 issued patents in the U.S. and four issued patents in Germany, France, Netherlands and United Kingdom. Additionally, we have ten pending U.S applications and twenty-one pending applications in Canada, China, the European Union, Japan, South Korea and Australia. We also have one pending Patent Cooperation Treaty application. The issued patents are predicted to expire between April 11, 2036 and March 4, 2044.

Interactions with Industrial Players

We believe that our VECG technology has the potential to be the most advanced ambulatory cardiac monitoring solution and is applicable in a number of form factors. In anticipation of FDA clearance, we are refining our go-to-market strategy and are encouraged by our early discussions with industry players and their interest in our technology.

Presentations at AHA

In August 2024, we were notified of the acceptance of two of our pilot studies for presentation at American Heart Association meeting in November 2024. The studies are designed to show early evidence of (1) clinical equivalence of the HeartBeam Synthesized 12L ECG to a standard 12L ECG for diagnosis of arrhythmia and (2) the use of the technology for heart attack detection.

At-the-Market Offering

On May 2, 2024, we entered into the PV Sales Agreement with Public Ventures, pursuant to which we may offer and sell from time to time, at our option, through or to Public Ventures, up to an aggregate of approximately $17 million of shares of the Company’s common stock, $0.0001 par value per share (the “Shares”). We will pay Public Ventures a commission at a fixed rate of 3.0% of the aggregate gross proceeds from each sale of the Shares under the PV Sales Agreement. There were 50,000 Shares issued under the ATM during the three months ended June 30, 2024. As of September 30, 2024, there was approximately $16.9 million available for issuance under the ATM following the use of the shelf registration on Form S-3 for the Agreements and the ATM during the quarter.

Any Shares to be offered and sold under the PV Sales Agreement will be issued and sold pursuant to our Registration Statement on Form S-3 (File No. 333-269520), filed with the Securities and Exchange Commission on February 1, 2023 and the prospectus supplement included therein, relating to the Offering, by methods deemed to be an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, or if specified by us, by any other method permitted by law.

In order to proceed with the PV Sales Agreement, we terminated the prior Sales Agreement with A.G.P/Alliance Global Partners.

Appointment of Additional Senior Management Team members

On September 10, 2024, we announced the appointment of Timothy Cruickshank as Chief Financial Officer (CFO). Mr. Cruickshank brings more than 15 years of public company experience with a focus on growing businesses with disruptive technologies through authentic leadership, strategic focus, data-driven decisions, and strong risk management and governance. He succeeds long-time CFO Richard Brounstein, who has been serving in an advisory capacity since retiring in February 2024.

On September 24, 2024, we announced the appointment of Lance Myers, PhD, a pioneer in digital health data analytics and body-worn biosensor technologies, as Chief Artificial Intelligence (AI) Scientist. In this newly created position, Dr. Myers will play a pivotal role in guiding how AI is applied to the Company’s core technology. Most recently, Dr. Myers served as AI Advisor to HeartBeam until September 23, 2024.
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On October 17, 2024, we announced the appointment of Robert Eno as Chief Executive Officer (CEO). Mr. Eno joined HeartBeam as President in January 2023 and will lead as the Company continues to work towards securing the foundational FDA 510(k) clearance for its vector-based technology and prepares for commercialization and growth. As part of a long-planned transition, Mr. Eno succeeds long-time CEO and founder, Branislav Vajdic, Ph.D. Dr. Vajdic will continue as President of HeartBeam, focused on innovating on the Company’s groundbreaking vector-based technology, driving research and development efforts, and advancing artificial intelligence (AI) applications.

Results of Operations

The following table summarizes our results of operations for the periods presented on our statement of operations data.

For three months ended September 30For nine months ended September 30
20242023Change% Change20242023Change% Change
(In thousands, except percentages)
Operating expenses:
General and administrative$2,176 $2,114 $62 3 %$6,778 $6,417 $361 6 %
Research and development2,893 1,623 1,270 78 %8,165 4,788 3,377 71 %
Total operating expenses5,069 3,737 1,332 36 %14,943 11,205 3,738 33 %
Loss from operations(5,069)(3,737)(1,332)36 %(14,943)(11,205)(3,738)33 %
Interest income96 267 (171)(64)%408 445 (37)(8)%
Other expense(6)— (6)100%(6)$— (6)100%
Income tax provision— — — — %— — — — %
Net loss$(4,979)$(3,470)$(1,509)43 %$(14,541)$(10,760)$(3,781)35 %

Summary of Statements of Operations for the three and nine months ended September 30, 2024 compared with the three and nine months ended September 30, 2023:

General and administrative (“G&A”) expenses increased by approximately $0.06 million or 3% during the three months ended September 30, 2024 as compared to the three months ended September 30, 2023. The increase in G&A expense is primarily related to increase in headcount amounting to $0.02 million, higher consultants costs of $0.07 million primarily offset by lower legal costs in this quarter compared to the prior period.

General and administrative (“G&A”) expenses increased by approximately $0.4 million or 6% during the nine months ended September 30, 2024. The increase in G&A expense is primarily related to non-cash stock-based compensation expense amounting to $0.7 million associated with additional awards granted since September 30, 2023, higher consulting costs of $0.4 million related to finance consultants, primarily offset by decrease in payroll cost of $0.4 million related to lower costs associated with restructuring of G&A headcount, decrease of $0.5 million comprising of lower investor relation costs, and legal costs incurred in this period compared to the prior period.

Research and development expenses (“R&D”) expenses increased by approximately $1.3 million or 78% during the three months ended September 30, 2024 as compared to the three months ended September 30, 2023. The increase in R&D expense is primarily related to increase in headcount of $0.3 million and non-cash stock-based compensation expense amounting to $0.1 million associated with additional awards granted since September 30, 2023, increase of clinical and AI related costs of $0.5 million, increase in consulting spend of $0.6 million offset by decrease in product development consulting cost of $0.1 million primarily driven by completion of milestone projects in prior period.

Research and development expenses (“R&D”) expenses increased by approximately $3.4 million or 71% during the nine months ended September 30, 2024 as compared to the nine months ended September 30, 2023. The increase in R&D
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expense is primarily related to increase in headcount of $0.9 million and non-cash stock-based compensation expense amounting to $0.5 million associated with additional awards granted since September 30, 2023, increase of clinical and AI related costs of $2.0 million, increase in consulting spend of $1.0 million offset by decrease in product development consulting cost of $0.8 million primarily driven by completion of milestone projects in prior period.

Other income during the three and nine months ended September 30, 2024 and 2024 is related to interest earned on our cash balances.


Liquidity and Capital Resources

Our cash requirements are and will continue to be, dependent upon a variety of factors. We expect to continue devoting significant capital resources to R&D and go-to-market strategies.

We have incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception. As of September 30, 2024, we have cash and cash equivalents balance of approximately $5.8 million. Based on our current business plan assumptions and expected cash burn rate, we believe that the existing cash is insufficient to fund operations for the next twelve months following the issuance of these financial statements. These factors raise substantial doubt regarding our ability to continue as a going concern.

Our continued operations and our commercialization plan will depend on the ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships until sufficient revenue can be generated to achieve positive cash flow from operations. We expect no material commercial revenue in 2024 nor can we provide assurance that a financing or strategic relationships will be available on acceptable terms.

As of September 30, 2024, we had approximately $5.8 million in cash, a decrease of $10.4 million from $16.2 million as of December 31, 2023.

Our cash is as follows (in thousands):
September 30, 2024December 31, 2023
Cash and cash equivalents$5,768 $16,189 

Cash flows for the nine months ended September 30, 2024 and 2023 (in thousands):
Nine Months ended September 30,
20242023
Net cash used in operating activities$(10,319)$(9,235)
Net cash used in investing activities(201)(144)
Net cash provided by financing activities105 24,994 

Operating Activities:

Net cash used in our operating activities of $10.3 million during the nine months ended September 30, 2024, is primarily due to our net loss of $14.5 million less $3.3 million in non-cash expenses and $0.9 million of net changes in operating assets and liabilities.

Net cash used by our operating activities of $9.2 million during the nine months ended September 30, 2023, is primarily due to our net loss of $10.8 million less $2.0 million in non-cash expenses and $0.4 million of net changes in operating assets and liabilities.

Investing Activities:

Net cash used in investing activities during the nine months ended September 30, 2024 of $0.2 million, is from the purchase of property and equipment.

Net cash used in investing activities during the nine months ended September 30, 2023, of $0.1 million, is primarily due to purchase of property and equipment.

Financing Activities
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During the nine months ended September 30, 2024, net cash provided by financing activities during the nine months ended September 30, 2024, of $0.1 million is primarily from net proceeds from sale of equity, net of issuance costs.

Net cash provided by financing activities during the nine months ended September 30, 2023, of $24.9 million, is primarily from the issuance of common stock, net of issuance costs.


Critical Accounting Estimates

There have been no material changes to our critical accounting estimates from the information provided in Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” included in our 2023 Annual Report except as covered below:

Stock-based Compensation

The compensation cost for all stock-based awards is measured at the grant date, based on the fair value of the award, determined using a Black-Scholes option pricing model for stock options and fair value on the date of grant for non-vested restricted stock, and is recognized as an expense over the employee’s requisite service period (generally the vesting period of the equity award). Determining the fair value of stock-based awards at the grant date requires significant estimates and judgments. Management has determined the fair value and vesting period of stock-based compensation to be a critical accounting estimate due to certain options containing performance-based vesting condition.

Research and Development: Clinical and Manufacturing Accruals

We record accruals for estimated costs of research, preclinical studies and clinical trials, and manufacturing development, which are a significant component of research and development expenses. A substantial portion of our ongoing research and development activities are conducted by one CRO. Our contract with this CRO include pass-through fees such as regulatory expenses, investigator fees, travel costs and other miscellaneous costs. We accrue the costs incurred under agreements with CRO based on estimates of actual work completed in accordance with the CRO agreement. We determine the estimated costs based on actual services performed by the CRO and clinical sites as at each period end. As actual costs become known, we adjust our accruals. Although we do not expect our estimates to be materially different from amounts actually incurred, our understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and could result in our reporting amounts that are too high or too low in any particular period.

Item 3. Quantitative and Qualitative Disclosures about Market Risk.

We do not hold any derivative instruments and do not engage in any hedging activities.

Item 4. Controls and Procedures.

Disclosure Controls and Procedures

We have adopted and maintain disclosure controls and procedures that are designed to provide reasonable assurance that information required to be disclosed in the reports filed under the Exchange Act, such as this Quarterly Report on Form 10-Q, is collected, recorded, processed, summarized and reported within the time periods specified in the rules of the SEC. Our disclosure controls and procedures are also designed to ensure that such information is accumulated and communicated to management to allow timely decisions regarding required disclosure. The material weaknesses previously identified but not yet remediated include (i) insufficient number of staff to maintain optimal segregation of duties and levels of oversight, and (ii) lack of formal risk assessment under COSO framework. As of September 30, 2024, based on evaluation of our disclosure controls and procedures, management concluded that our disclosure controls and procedures were not effective.

Notwithstanding the material weaknesses described above, our management team, including the CEO and CFO have concluded that the condensed unaudited financial statements, and other financial information included in this quarterly report, fairly presents in all material respects our financial condition, results of operations, and cash flows as of and for the periods presented in this quarterly report.

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Since the third quarter of 2023, we have undertaken specific remediation actions to address the material weaknesses in our financial reporting specifically remediating the material weakness as identified in the 2023 Form 10-K related to documentation of policies and procedures, and insufficient GAAP experience regarding complex transactions and reporting. These remediation actions included hiring a Controller in July 2023, who has extensive experience in developing and implementing internal controls and executing plans to remediate control deficiencies, performing risk assessment under COSO framework, and hiring a Chief Financial Officer in September 2024, who has extensive experience leading public entities. We are establishing more robust processes related to the review of complex accounting transactions, the preparation of account reconciliations and the review of journal entries. We will continue to assess the remaining weaknesses as we continue to implement and refine control policies and procedures.

Changes in Internal Control

We have hired personnel with sufficient GAAP experience, completed documentation of policies and procedures, and documented proper approval processes including documentation of reviews to address the material weaknesses. There has been no change in our internal control procedures over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) that occurred during our fiscal quarter ended September 30, 2024 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
18
PART II-OTHER INFORMATION
Item 1. Legal Proceedings.

There are no actions, suits, proceedings, inquiries or investigation before or by any court, public board, government agency, self-regulatory organization or body pending or, to the knowledge of the executive officers of our Company or any of our subsidiaries, threatened against or affecting our Company, our common stock, any of our officers or directors in their capacities as such, in which an adverse decision could have a material adverse effect.

Item 1A. Risk Factors.

Not applicable as we are a smaller reporting company.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

(A) Unregistered Sales of Equity Securities

There were no sales of equity securities sold during the period covered by this Quarterly Report that were not registered under the Securities Act and were not previously reported in a Current Report on Form 8-K filed by the Company.

(B) Use of Proceeds

Not applicable.

(C) Issuer Purchases of Equity Securities

Not applicable.

Item 3. Defaults Upon Senior Securities.
Not applicable

Item 4. Mine Safety Disclosures (Removed and Reserved)
Not applicable.

Item 5. Other Information.
Not applicable.
19
Item 6. Exhibits
The exhibit index set forth below is incorporated by reference in response to this Item 6.
Exhibit
Number		Description of Exhibit
3.1
3.2
3.3
3.4
31.1*
32.1**
31.2*
32.2**
101.INSXBRL Instance Document+
101.SCHXBRL Taxonomy Extension Schema Document+
101.CALXBRL Taxonomy Extension Calculation Linkbase Document+
101.DEFXBRL Taxonomy Extension Definition Linkbase Document+
101.LABXBRL Taxonomy Extension Label Linkbase Document+
101.PREXBRL Taxonomy Extension Presentation Linkbase Document+
104Cover Page Interactive Data File - The cover page iXBRL tags are embedded within the inline XBRL document+
*Filed herewith.
**Furnished herewith.
+Pursuant to Rule 406T of Regulation S-T, the Interactive Data Files in Exhibit 101 hereto are deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, are deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, and otherwise are not subject to liability under those sections.



20
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
HEARTBEAM, Inc.
By:/s/ Robert Eno
Name:Robert Eno
Title:
Chief Executive Officer
Dated: November 7, 2024
(Principal Executive Officer)
By:/s/ Timothy Cruickshank
Name:Timothy Cruickshank
Title:
Chief Financial Officer
Dated: November 7, 2024
(Principal Financial and Accounting Officer)

21

Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO RULE 13a-14(a)/RULE 15d-14(a) OF THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Robert Eno, certify that:
1.    I have reviewed this Quarterly Report on Form 10-Q of HeartBeam, Inc.;
2.    Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.    Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.    The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)    Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)    Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)    Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)    Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.    The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a)    All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)    Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: November 7, 2024By: /s/ Robert Eno
Robert Eno
Chief Executive Officer
(Principal Executive Officer)


Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER
PURSUANT TO RULE 13a-14(a)/RULE 15d-14(a) OF THE SECURITIES EXCHANGE ACT OF 1934,
AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Timothy Cruickshank, certify that:
1.    I have reviewed this Quarterly Report on Form 10-Q of HeartBeam, Inc.;
2.    Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.    Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.    The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a)    Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)    Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)    Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)    Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.    The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
a)    All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
b)    Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
Date: November 7, 2024By: /s/ Timothy Cruickshank
Timothy Cruickshank
Chief Financial Officer
(Principal Financial and Accounting Officer)


Exhibit 32.1
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002


In connection with the Quarterly Report of HeartBeam, Inc. (the “Registrant”) on Form 10-Q for the period ending September 30, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Robert Eno, Chief Executive Officer of the Registrant, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

(1)    The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)    The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.
Date: November 7, 2024By: /s/ Robert Eno
 Robert Eno
Chief Executive Officer
(Principal Executive Officer)




Exhibit 32.2
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002


In connection with the Quarterly Report of HeartBeam, Inc. (the “Registrant”) on Form 10-Q for the period ending September 30, 2024 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Timothy Cruickshank, Chief Financial Officer of the Registrant, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:

(1)    The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)    The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.
Date: November 7, 2024By: /s/ Timothy Cruickshank
Timothy Cruickshank
Chief Financial Officer
(Principal Financial and Accounting Officer)



v3.24.3
Cover Page - shares
 9 Months Ended
Sep. 30, 2024
Nov. 05, 2024
Document Information [Line Items]    
Document Type 10-Q  
Document Quarterly Report true  
Document Period End Date Sep. 30, 2024  
Document Transition Report false  
Entity File Number 001-41060  
Entity Registrant Name HEARTBEAM, INC.  
Entity Incorporation, State or Country Code DE  
Entity Tax Identification Number 47-4881450  
Entity Address, Address Line One 2118 Walsh Avenue  
Entity Address, Address Line Two Suite 210  
Entity Address, City or Town Santa Clara  
Entity Address, State or Province CA  
Entity Address, Postal Zip Code 95050  
City Area Code 408  
Local Phone Number 899-4443  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company true  
Entity Ex Transition Period false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   26,665,470
Entity Central Index Key 0001779372  
Current Fiscal Year End Date --12-31  
Document Fiscal Year Focus 2024  
Document Fiscal Period Focus Q3  
Amendment Flag false  
Common Stock    
Document Information [Line Items]    
Title of 12(b) Security Common Stock  
Trading Symbol BEAT  
Security Exchange Name NASDAQ  
Warrants    
Document Information [Line Items]    
Title of 12(b) Security Warrants  
Trading Symbol BEATW  
Security Exchange Name NASDAQ  
v3.24.3
Condensed Balance Sheets (Unaudited) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Current Assets:    
Cash and cash equivalents $ 5,768 $ 16,189
Prepaid expenses and other current assets 376 636
Total Current Assets 6,144 16,825
Property and equipment, net 457 256
Other assets 56 50
Total Assets 6,657 17,131
Current Liabilities:    
Accounts payable and accrued expenses (includes related party $5 and $2, respectively) 1,856 1,194
Total Current Liabilities 1,856 1,194
Total Liabilities 1,856 1,194
Commitments (Note 7)
Stockholders’ Equity    
Preferred stock - $0.0001 par value; 10,000,000 authorized; 0 shares outstanding at September 30, 2024 and December 31, 2023 0 0
Common stock - $0.0001 par value 100,000,000 shares authorized; 26,594,928 and 26,329,032 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively 3 3
Additional paid in capital 56,164 52,759
Accumulated deficit (51,366) (36,825)
Total Stockholders’ Equity 4,801 15,937
Total Liabilities and Stockholders’ Equity $ 6,657 $ 17,131
v3.24.3
Condensed Balance Sheets (Unaudited) (Parenthetical) - USD ($)
$ in Thousands
Sep. 30, 2024
Dec. 31, 2023
Current Liabilities:    
Due to related party $ 1,856 $ 1,194
Stockholders’ Equity    
Preferred stock, par value (in dollars per share) $ 0.0001 $ 0.0001
Preferred stock, shares authorized (in shares) 10,000,000 10,000,000
Preferred stock, shares outstanding (in shares) 0 0
Common stock, par value (in dollars per share) $ 0.0001 $ 0.0001
Common stock, shares authorized (in shares) 100,000,000 100,000,000
Common stock, shares issued (in shares) 26,594,928 26,329,032
Common stock, shares outstanding (in shares) 26,594,928 26,329,032
Related Party    
Current Liabilities:    
Due to related party $ 5 $ 2
v3.24.3
Condensed Statements of Operations (Unaudited) - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Operating Expenses:        
General and administrative $ 2,176 $ 2,114 $ 6,778 $ 6,417
Research and development 2,893 1,623 8,165 4,788
Total operating expenses 5,069 3,737 14,943 11,205
Loss from operations (5,069) (3,737) (14,943) (11,205)
Other Income and (Expense)        
Interest income 96 267 408 445
Other expense (6) 0 (6) 0
Total other income 90 267 402 445
Loss before provision for income taxes (4,979) (3,470) (14,541) (10,760)
Income tax provision 0 0 0 0
Net Loss $ (4,979) $ (3,470) $ (14,541) $ (10,760)
Net loss per share, basic (in dollars per share) $ (0.19) $ (0.13) $ (0.55) $ (0.59)
Net loss per share, diluted (in dollars per share) $ (0.19) $ (0.13) $ (0.55) $ (0.59)
Weighted average common shares outstanding, basic (in shares) 26,752,297 26,449,168 26,610,760 18,252,654
Weighted average common shares outstanding, diluted (in shares) 26,752,297 26,449,168 26,610,760 18,252,654
v3.24.3
Condensed Statement of Changes in Stockholders’ Equity (Unaudited) - USD ($)
$ in Thousands
Total
Common Stock
Additional Paid-in Capital
Accumulated Deficit
Beginning balance (in shares) at Dec. 31, 2022   8,009,743    
Beginning balance at Dec. 31, 2022 $ 2,374 $ 1 $ 24,559 $ (22,186)
Increase (Decrease) in Stockholders' Equity [Roll Forward]        
Stock based compensation expense 2,021   2,021  
Sale of Common Stock under ATM, net of issuance costs (in shares)   17,872,955    
Sale of Common Stock under ATM, net of issuance costs 24,764 $ 2 24,762  
Stock issuance upon exercise of stock options (in shares)   180,072    
Stock issuance upon exercise of stock options 214   214  
Stock issuance upon vesting of restricted stock units (in shares)   255,220    
Stock issuance upon exercise of warrants (in shares)   7,292    
Stock issuance upon exercise of warrants 16   16  
Net loss (10,760)     (10,760)
Ending balance (in shares) at Sep. 30, 2023   26,325,282    
Ending balance at Sep. 30, 2023 18,629 $ 3 51,572 (32,946)
Beginning balance (in shares) at Jun. 30, 2023   25,990,516    
Beginning balance at Jun. 30, 2023 21,062 $ 3 50,535 (29,476)
Increase (Decrease) in Stockholders' Equity [Roll Forward]        
Stock based compensation expense 926   926  
Stock issuance upon exercise of stock options (in shares)   92,046    
Stock issuance upon exercise of stock options 111   111  
Stock issuance upon vesting of restricted stock units (in shares)   242,720    
Net loss (3,470)     (3,470)
Ending balance (in shares) at Sep. 30, 2023   26,325,282    
Ending balance at Sep. 30, 2023 $ 18,629 $ 3 51,572 (32,946)
Beginning balance (in shares) at Dec. 31, 2023 26,329,032 26,329,032    
Beginning balance at Dec. 31, 2023 $ 15,937 $ 3 52,759 (36,825)
Increase (Decrease) in Stockholders' Equity [Roll Forward]        
Stock based compensation expense 3,300   3,300  
Sale of Common Stock under ATM, net of issuance costs (in shares)   50,000    
Sale of Common Stock under ATM, net of issuance costs $ 76   76  
Stock issuance upon exercise of stock options (in shares) 38,069 38,069    
Stock issuance upon exercise of stock options $ 29   29  
Stock issuance upon vesting of restricted stock units (in shares)   177,827    
Net loss $ (14,541)     (14,541)
Ending balance (in shares) at Sep. 30, 2024 26,594,928 26,594,928    
Ending balance at Sep. 30, 2024 $ 4,801 $ 3 56,164 (51,366)
Beginning balance (in shares) at Jun. 30, 2024   26,562,111    
Beginning balance at Jun. 30, 2024 8,706 $ 3 55,090 (46,387)
Increase (Decrease) in Stockholders' Equity [Roll Forward]        
Stock based compensation expense 1,053   1,053  
Stock issuance upon exercise of stock options (in shares)   32,817    
Stock issuance upon exercise of stock options 21   21  
Net loss $ (4,979)     (4,979)
Ending balance (in shares) at Sep. 30, 2024 26,594,928 26,594,928    
Ending balance at Sep. 30, 2024 $ 4,801 $ 3 $ 56,164 $ (51,366)
v3.24.3
Condensed Statements of Cash Flows (Unaudited) - USD ($)
$ in Thousands
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Cash Flows From Operating Activities        
Net loss $ (4,979) $ (3,470) $ (14,541) $ (10,760)
Adjustments to reconcile net loss to net cash used in operating activities        
Stock based compensation expense     3,300 2,021
Changes in operating assets and liabilities:        
Prepaid expenses and other current assets     260 150
Accounts payable and accrued expenses     662 (646)
Net cash used in operating activities     (10,319) (9,235)
Cash Flows From Investing Activities        
Purchase of property and equipment     (201) (144)
Net cash used in investing activities     (201) (144)
Cash Flows From Financing Activities        
Proceeds from sale of equity, net of issuance costs     76 24,764
Proceeds from exercise of stock options     29 214
Proceeds from exercise of warrants     0 16
Net cash provided by financing activities     105 24,994
Net increase (decrease) in cash and restricted cash     (10,415) 15,615
Cash, cash equivalents and restricted cash – Beginning of period     16,239 3,594
Cash, cash equivalents and restricted cash – Ending of period 5,824 19,209 5,824 19,209
Reconciliation of cash, cash equivalents and restricted cash:        
Cash and cash equivalents 5,768 19,184 5,768 19,184
Restricted cash (included in other assets) 56 25 56 25
Total cash, cash equivalents and restricted cash $ 5,824 $ 19,209 $ 5,824 $ 19,209
v3.24.3
ORGANIZATION AND OPERATIONS
 9 Months Ended
Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
ORGANIZATION AND OPERATIONS ORGANIZATION AND OPERATIONS
HeartBeam, Inc. (“HeartBeam” or the “Company”) is a cardiac technology company focusing on developing and commercializing higher resolution ambulatory Electrocardiogram (“ECG”) solutions that enable the detection and monitoring of cardiac disease outside a healthcare facility setting. The Company’s ability to develop higher resolution ECG solutions is achieved through the development of the Company’s proprietary and patented Vector Electrocardiography (“VECG”) technology platform. HeartBeam’s VECG is capable of developing three-dimensional (3D) representations of cardiac electrical activity by displaying the spatial locations of ECG waveforms that demonstrated in early studies to deliver diagnostic capability equal or superior to traditional hospital-based ECG systems.

The Company has validated this technology and is seeking U.S. Food and Drug Administration (“FDA”) clearance of its initial telehealth products. The Company filed a 510(k) submission in 2023 for its initial product, a patient-held VECG device. With a planned second submission, this product will become an ambulatory device, carried by patients, which can synthesize a 12L ECG for physician review.

The Company was incorporated in 2015 as a Delaware corporation. The Company operates as one segment and its operations are based in Santa Clara, California.
v3.24.3
GOING CONCERN AND OTHER UNCERTAINTIES
 9 Months Ended
Sep. 30, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
GOING CONCERN AND OTHER UNCERTAINTIES GOING CONCERN AND OTHER UNCERTAINTIES
The Company is subject to a number of risks similar to those of early stage medical device companies, including dependence on key individuals and products, the inherent uncertainties with regulatory approvals, the difficulties inherent in the development of a commercial market, the potential need to obtain additional capital, competition from larger companies, other technology companies and other technologies.

The Company has incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception. As of September 30, 2024 the Company has a cash and cash equivalents balance of approximately $5.8 million. Based on its current business plan assumptions and expected cash burn rate, the Company believes that the existing cash is insufficient to fund operations for the next twelve months following the issuance of these financial statements. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern.

Therefore, the Company’s continued operations will depend on its ability to raise additional capital through various potential sources, such as equity and/or debt financings, strategic relationships until sufficient revenue can be generated to achieve positive cash flow from operations. The Company expects no material commercial revenue in 2024.

The Company continues to maintain strong financial discipline as it achieves critical R&D, clinical and regulatory milestones in advance of commercialization. Management believes the continued achievement of these milestones will provide the Company the ability to raise additional capital. Management can provide no assurance that such financing or strategic relationships will be available on acceptable terms, or at all, which would likely have a material adverse effect on the Company and its financial statements.

On May 2, 2024, the Company entered into a Sales Agreement (“PV Sales Agreement”) with Public Ventures, LLC, as sales agent (“Public Ventures”), pursuant to which the Company may sell up to an aggregate of approximately $17 million of shares of the Company’s common stock. There were 50,000 shares issued under the At The Market (“ATM”) during the nine months ended September 30, 2024. As of September 30, 2024, there was approximately $16.9 million available for issuance under the ATM.
The accompanying unaudited condensed financial statements do not include any adjustments relating to the recoverability and classification of asset carrying amounts or the amount and classification of liabilities that may result should the Company be unable to continue as a going concern.
v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
 9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
BASIS OF PRESENTATION

The accompanying condensed unaudited financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America ("US GAAP") and in conformity with the instructions on Form 10-Q and Rule 8-03 of Regulation S-X and the related rules and regulations of the Securities and Exchange Commission (“SEC”) and have been prepared on a basis which assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. In the opinion of management, the unaudited interim condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results of operations for the periods presented. The interim operating results are not necessarily indicative of results that may be expected for any subsequent period. The accompanying condensed unaudited financial statements should be read in conjunction with the Company’s audited annual financial statements and notes thereto included in the Company’s Form 10-K filed with the SEC on March 20, 2024 (“2023 Annual Report”).

CASH, CASH EQUIVALENTS AND RESTRICTED CASH

The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash deposits. The Company maintains its cash in institutions insured by the Federal Deposit Insurance Corporation (“FDIC”) and has cash balances in accounts which exceed the federally insured limits as of September 30, 2024 and December 31, 2023. The Company has made a deposit to the bank for their credit cards in the amount of $56,000 and $50,000 and is classified as restricted cash included in other assets as of September 30, 2024, and December 31, 2023, respectively.

USE OF ESTIMATES

The preparation of financial statements in conformity with US GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be based on amounts that differ from those estimates.

PROPERTY AND EQUIPMENT, NET

Property and equipment are stated at cost less accumulated depreciation. Depreciation of property and equipment is calculated using the straight-line method over the estimated useful lives of the assets. The Company regularly evaluates the estimated remaining useful lives of the Company’s property and equipment, net, to determine whether events or changes in circumstances warrant a revision to the remaining period of depreciation. Maintenance and repairs are expensed as incurred.

During the three months ended September 30, 2024, the Company has capitalized tools amounting to $52,200, which is being depreciated based on useful life of 7 years. Depreciation and amortization expense for the three months ended September 30, 2024 was nominal. As of September 30, 2024, property and equipment, net represents machinery and equipment of $51,600 and construction-in-progress related to tooling development that has not been placed into service is amounting to $405,000 and $256,000 as of September 30, 2024, and December 31, 2023, respectively. Construction-in-progress amounts are not subject to depreciation as such assets are not yet available for their intended use.

NET LOSS PER COMMON SHARE

Basic net loss per share excludes the effect of dilution and is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding.

Diluted net loss per share is computed by giving effect to all potential shares of common stock, including stock options and warrants to the extent dilutive. Basic net loss per share was the same as diluted net loss per share for the three and nine months ended September 30, 2024 and 2023 as the inclusion of all potential common shares outstanding would have an anti-dilutive effect.
In accordance with ASC 260-10-45-13, exercisable penny options are included in the calculation of weighted average basic and diluted earnings per share. Penny options of 178,533 and 176,105 have been included in the calculation of weighted average basic and diluted earnings per share for the three and nine months ended September 30, 2024 and September 30, 2023, respectively.

The following is a summary of awards outstanding as of September 30, 2024 and 2023, which are not included in the computation of basic and diluted weighted average shares:
Three and Nine months ended
September 30,
20242023
Stock options (excluding exercisable penny stock options)7,244,175 4,782,020 
Restricted stock units283,411 221,631 
Warrants5,152,397 5,152,397 
Total12,679,983 10,156,048 

RECENTLY ISSUED ACCOUNTING STANDARDS

Not Yet Adopted as of September 30, 2024:

In November 2023, the Financial Standards Accounting Board (FASB) issued Accounting Standards Update (ASU) 2023-07 "Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures" which expands annual and interim disclosure requirements for reportable segments, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 is effective for the Company’s annual periods beginning January 1, 2024, and for interim periods beginning January 1, 2025, with early adoption permitted. The Company is evaluating the disclosure impact of the updated standard on the Company’s financial statement disclosures.

In December 2023, the FASB issued ASU 2023-09 "Income Taxes (Topics 740): Improvements to Income Tax Disclosures" to expand the disclosure requirements for income taxes, specifically related to the rate reconciliation and income taxes paid. ASU 2023-09 is effective for the Company’s annual periods beginning January 1, 2025, with early adoption permitted. The Company is currently evaluating the potential effect that the updated standard will have on the Company’s financial statement disclosures.

In March 2024, the FASB issued ASU 2024-02 “Codification Improvements – Amendments to Remove References to the Concepts Statements.” This amendments to the Codification that remove references to various Concepts Statement. The amendments in this update are effective for public business entities for fiscal years beginning after December 15, 2024. Early application of the amendments in this update is permitted for all entities, for any fiscal year or interim period for which financial statements have not yet been issued (or made available for issuance). If an entity adopts the amendments in an interim period, it must adopt them as of the beginning of the fiscal year that includes that interim period. The Company is currently evaluating the impact that the adoption of this standard will have on the Company’s financial statement disclosures.
v3.24.3
STOCKHOLDERS’ EQUITY
 9 Months Ended
Sep. 30, 2024
Equity [Abstract]  
STOCKHOLDERS’ EQUITY STOCKHOLDERS’ EQUITY
WARRANTS

The following is a summary of warrant activity during the nine months ended September 30, 2024:
Number of
shares		Weighted
average exercise
price		Weighted
average
remaining life (years)		Aggregate
intrinsic value
(in thousands)
Outstanding and exercisable - December 31, 2023
5,152,397 $4.71 3.35$792 
Exercised— — — — 
Expired— — — — 
Outstanding and exercisable – September 30, 2024
5,152,397 $4.71 2.59$742 
v3.24.3
STOCK-BASED COMPENSATION
 9 Months Ended
Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]  
STOCK-BASED COMPENSATION STOCK-BASED COMPENSATION
At the June 2024 annual stockholders’ meeting the 2022 Equity Incentive Plan was amended to increase the number of authorized shares from 5,900,000 shares to 8,900,000.
STOCK OPTIONS
The following is a summary of stock option activity during the nine months ended September 30, 2024:
Number of
options
outstanding		Weighted
average
exercise
price		Average
remaining
contractual life
(in years)		Aggregate
intrinsic value
(in thousands)
Outstanding – December 31, 2023
6,092,525 $2.22 8.7$2,945 
Options granted
1,435,000 2.32 
Options exercised
(38,069)0.77 
Options cancelled(66,748)3.54 
Outstanding – September 30, 2024
7,422,708 $2.24 8.6$2,826 
Exercisable – September 30, 2024
2,147,402 $1.96 7.5$1,534 
The Company estimates the fair values of stock options using the Black-Scholes option-pricing model on the date of grant. For the nine months ended September 30, 2024 and 2023, the assumptions used in the Black-Scholes option pricing model, which was used to estimate the grant date fair value per option, were as follows:

Nine Months ended September 30,
20242023
Weighted-average Black-Scholes option pricing model assumptions:
Volatility
125.33% - 128.85%
110.23% - 110.64%
Expected term (in years)
6.00 - 7.00
5.85 - 6.07
Risk-free rate
3.59% - 4.60%
3.54% - 3.95%
Expected dividend yield$— $— 
Weighted average grant date fair value per share
$1.81 - $2.48
$1.75 - $3.38

RESTRICTED STOCK UNITS
The following is a summary of RSU’s awards activity during the nine months ended September 30, 2024:
Nine Months ended September 30, 2024
Numbers of SharesWeighted Average Grant Date Fair value
Non-Vested at beginning of period217,881 $3.12 
Shares granted243,357 2.26 
Shares vested(177,827)3.13 
Non-vested at the end of period283,411 $2.38 
STOCK BASED COMPENSATION

The following is a summary of stock-based compensation expense (rounded):
Three months ended September 30,Nine Months ended September 30,
2024202320242023
General and administrative
Stock options560,000 589,500 1,898,000 1,352,100 
RSU’s149,000 153,000 433,000 323,000 
Total general and administrative709,000 742,500 2,331,000 1,675,100 
Research and development
Stock options334,000 173,600 941,000 336,100 
  RSU’s 10,000 10,200 28,000 10,200 
Total research and development344,000 183,800 969,000 346,300 
Total1,053,000 926,300 3,300,000 2,021,400 

During the nine months ended 2023, the Company granted 2,208,000 options to various executives and employees. Sixty percent (60%) of these options vest based on FDA Clearance for marketing of HeartBeam’s synthesized 12L product and the remaining forty percent (40%) vest monthly over a period of 48 months.

The Company calculated the fair value for each of these grants using the Black-Scholes option pricing model and the performance-based options are expensed beginning from date of grant to the expected FDA clearance, which is based on management’s probability assessment performed on a quarterly basis.

As of September 30, 2024, total compensation cost not yet recognized related to unvested stock options and unvested RSUs was approximately $8.3 million and $0.5 million, respectively, which is expected to be recognized over a weighted-average period of 2.9 years and 0.85 years, respectively.
v3.24.3
RELATED PARTY TRANSACTIONS
 9 Months Ended
Sep. 30, 2024
Related Party Transactions [Abstract]  
RELATED PARTY TRANSACTIONS RELATED PARTY TRANSACTIONS
During the course of business, the Company obtains accounting services from CTRLCFO, a firm in which a prior executive of the Company had significant influence. On December 29, 2023, this executive, informed the Company of his plans to retire from his position as of February 1, 2024 and as such ceased to be a related party as of February 1, 2024. The Company had balances due to this firm amounting to approximately $2,000 as of December 31, 2023.

During April 2024, the Company entered into consulting agreement with one of the independent Board of Directors to provide business development consulting services. For these consulting services, the Company agreed to pay $5,000 per month as remuneration and granted 70,000 options to vest during over a period of 36 months. During the three and nine months ended September 30, 2024, the Company recognized $25,700 and $50,200, respectively related to these consulting services, which includes stock based compensation expense of $10,700 and $20,200, respectively.
v3.24.3
COMMITMENTS
 9 Months Ended
Sep. 30, 2024
Commitments and Contingencies Disclosure [Abstract]  
COMMITMENTS COMMITMENTS
Lease Obligations

Prior to February 1, 2024, the Company was in a month-to-month lease agreement for its headquarters. The agreement was for an undefined term that could be cancelled at any time, given one month’s notice by either party. The Company’s monthly rent expense associated with this agreement was approximately $1,800. This headquarters lease was in the name of the Company’s Chief Executive Officer, and the cost was reimbursed monthly to CEO until January 31, 2024 when the Company terminated the month-to-month lease, and entered into a new lease in name of the Company with the same landlord. The new lease commenced on February 1, 2024, for initial period of 3 years. The Company performed an assessment and concluded that amount of operating lease right-of-use, or ROU assets was below the Company’s capitalization thresholds set in accordance with ASC 842. For the three and nine months ended September 30, 2024 rent was approximately $5,400 and $15,840, respectively. For the three and nine months ended September 30, 2023, rent expense was approximately $4,000 and $12,000, respectively.
Professional Services Agreement

In March 2022, the Company entered into a professional services agreement with Triple Ring Technologies, Inc. (“TRT”), a co-development company, to assist in the design and development of the Company’s telehealth complete solution 3D vector ECG collection device for remote heart attack or MI monitoring. This agreement was followed by several amendments. The agreement with TRT includes a commitment totaling $1.7 million. For the three and nine months ended September 30, 2024, the Company has expensed approximately $0.1 million and $0.3 million, respectively. For the three and nine months ended September 30, 2023, the Company has expensed approximately $0.3 million and $0.8 million, respectively.

As of September 30, 2024, the Company has a remaining commitment of $0.1 million.

Clinical Research Organization

On March 8, 2024, the Company has entered into an agreement with Clinical Research Organization (CRO) to perform certain services related to project set up, clinical trial management and monitoring during next six months. As per terms of the agreement, the Company will pay CRO approximately $0.5 million for these services. Additionally, the Company has signed a Clinical Study Agreement with first of five sites to carry out the clinical study for which CRO will act as Company sponsor in relation to payment for these services. The total cost of the clinical trial including the CRO cost is expected to approximate $0.9 million. For the three months and nine months ended September 30, 2024, the Company has expensed $0.1 million and $0.7 million based on actual services performed by the CRO and clinical sites, of which $0.1 million was accrued as of September 30, 2024. As of September 30, 2024, the Company has a remaining commitment of $0.1 million.
v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
 9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
BASIS OF PRESENTATION
BASIS OF PRESENTATION
The accompanying condensed unaudited financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America ("US GAAP") and in conformity with the instructions on Form 10-Q and Rule 8-03 of Regulation S-X and the related rules and regulations of the Securities and Exchange Commission (“SEC”) and have been prepared on a basis which assumes that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. In the opinion of management, the unaudited interim condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results of operations for the periods presented. The interim operating results are not necessarily indicative of results that may be expected for any subsequent period. The accompanying condensed unaudited financial statements should be read in conjunction with the Company’s audited annual financial statements and notes thereto included in the Company’s Form 10-K filed with the SEC on March 20, 2024 (“2023 Annual Report”).
CASH, CASH EQUIVALENTS AND RESTRICTED CASH
CASH, CASH EQUIVALENTS AND RESTRICTED CASH
The Company considers all highly liquid investments with an original maturity of three months or less when purchased to be cash equivalents. Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash deposits. The Company maintains its cash in institutions insured by the Federal Deposit Insurance Corporation (“FDIC”) and has cash balances in accounts which exceed the federally insured limits as of September 30, 2024 and December 31, 2023.
USE OF ESTIMATES
USE OF ESTIMATES

The preparation of financial statements in conformity with US GAAP, requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Due to the inherent uncertainty involved in making estimates, actual results reported in future periods may be based on amounts that differ from those estimates.
PROPERTY AND EQUIPMENT, NET
PROPERTY AND EQUIPMENT, NET
Property and equipment are stated at cost less accumulated depreciation. Depreciation of property and equipment is calculated using the straight-line method over the estimated useful lives of the assets. The Company regularly evaluates the estimated remaining useful lives of the Company’s property and equipment, net, to determine whether events or changes in circumstances warrant a revision to the remaining period of depreciation. Maintenance and repairs are expensed as incurred.
NET LOSS PER COMMON SHARE
NET LOSS PER COMMON SHARE

Basic net loss per share excludes the effect of dilution and is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding.

Diluted net loss per share is computed by giving effect to all potential shares of common stock, including stock options and warrants to the extent dilutive. Basic net loss per share was the same as diluted net loss per share for the three and nine months ended September 30, 2024 and 2023 as the inclusion of all potential common shares outstanding would have an anti-dilutive effect.
In accordance with ASC 260-10-45-13, exercisable penny options are included in the calculation of weighted average basic and diluted earnings per share.
RECENTLY ISSUED ACCOUNTING STANDARDS
RECENTLY ISSUED ACCOUNTING STANDARDS

Not Yet Adopted as of September 30, 2024:

In November 2023, the Financial Standards Accounting Board (FASB) issued Accounting Standards Update (ASU) 2023-07 "Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures" which expands annual and interim disclosure requirements for reportable segments, primarily through enhanced disclosures about significant segment expenses. ASU 2023-07 is effective for the Company’s annual periods beginning January 1, 2024, and for interim periods beginning January 1, 2025, with early adoption permitted. The Company is evaluating the disclosure impact of the updated standard on the Company’s financial statement disclosures.

In December 2023, the FASB issued ASU 2023-09 "Income Taxes (Topics 740): Improvements to Income Tax Disclosures" to expand the disclosure requirements for income taxes, specifically related to the rate reconciliation and income taxes paid. ASU 2023-09 is effective for the Company’s annual periods beginning January 1, 2025, with early adoption permitted. The Company is currently evaluating the potential effect that the updated standard will have on the Company’s financial statement disclosures.

In March 2024, the FASB issued ASU 2024-02 “Codification Improvements – Amendments to Remove References to the Concepts Statements.” This amendments to the Codification that remove references to various Concepts Statement. The amendments in this update are effective for public business entities for fiscal years beginning after December 15, 2024. Early application of the amendments in this update is permitted for all entities, for any fiscal year or interim period for which financial statements have not yet been issued (or made available for issuance). If an entity adopts the amendments in an interim period, it must adopt them as of the beginning of the fiscal year that includes that interim period. The Company is currently evaluating the impact that the adoption of this standard will have on the Company’s financial statement disclosures.
v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
 9 Months Ended
Sep. 30, 2024
Accounting Policies [Abstract]  
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share
The following is a summary of awards outstanding as of September 30, 2024 and 2023, which are not included in the computation of basic and diluted weighted average shares:
Three and Nine months ended
September 30,
20242023
Stock options (excluding exercisable penny stock options)7,244,175 4,782,020 
Restricted stock units283,411 221,631 
Warrants5,152,397 5,152,397 
Total12,679,983 10,156,048 
v3.24.3
STOCKHOLDERS’ EQUITY (Tables)
 9 Months Ended
Sep. 30, 2024
Equity [Abstract]  
Schedule of Warrant Activity
The following is a summary of warrant activity during the nine months ended September 30, 2024:
Number of
shares		Weighted
average exercise
price		Weighted
average
remaining life (years)		Aggregate
intrinsic value
(in thousands)
Outstanding and exercisable - December 31, 2023
5,152,397 $4.71 3.35$792 
Exercised— — — — 
Expired— — — — 
Outstanding and exercisable – September 30, 2024
5,152,397 $4.71 2.59$742 
v3.24.3
STOCK-BASED COMPENSATION (Tables)
 9 Months Ended
Sep. 30, 2024
Share-Based Payment Arrangement [Abstract]  
Schedule of Stock Option, Activity
The following is a summary of stock option activity during the nine months ended September 30, 2024:
Number of
options
outstanding		Weighted
average
exercise
price		Average
remaining
contractual life
(in years)		Aggregate
intrinsic value
(in thousands)
Outstanding – December 31, 2023
6,092,525 $2.22 8.7$2,945 
Options granted
1,435,000 2.32 
Options exercised
(38,069)0.77 
Options cancelled(66,748)3.54 
Outstanding – September 30, 2024
7,422,708 $2.24 8.6$2,826 
Exercisable – September 30, 2024
2,147,402 $1.96 7.5$1,534 
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions For the nine months ended September 30, 2024 and 2023, the assumptions used in the Black-Scholes option pricing model, which was used to estimate the grant date fair value per option, were as follows:
Nine Months ended September 30,
20242023
Weighted-average Black-Scholes option pricing model assumptions:
Volatility
125.33% - 128.85%
110.23% - 110.64%
Expected term (in years)
6.00 - 7.00
5.85 - 6.07
Risk-free rate
3.59% - 4.60%
3.54% - 3.95%
Expected dividend yield$— $— 
Weighted average grant date fair value per share
$1.81 - $2.48
$1.75 - $3.38
Schedule of Nonvested Restricted Stock Units Activity
The following is a summary of RSU’s awards activity during the nine months ended September 30, 2024:
Nine Months ended September 30, 2024
Numbers of SharesWeighted Average Grant Date Fair value
Non-Vested at beginning of period217,881 $3.12 
Shares granted243,357 2.26 
Shares vested(177,827)3.13 
Non-vested at the end of period283,411 $2.38 
Schedule of Stock-Based Compensation
The following is a summary of stock-based compensation expense (rounded):
Three months ended September 30,Nine Months ended September 30,
2024202320242023
General and administrative
Stock options560,000 589,500 1,898,000 1,352,100 
RSU’s149,000 153,000 433,000 323,000 
Total general and administrative709,000 742,500 2,331,000 1,675,100 
Research and development
Stock options334,000 173,600 941,000 336,100 
  RSU’s 10,000 10,200 28,000 10,200 
Total research and development344,000 183,800 969,000 346,300 
Total1,053,000 926,300 3,300,000 2,021,400 
v3.24.3
ORGANIZATION AND OPERATIONS (Details)
 9 Months Ended
Sep. 30, 2024
segment
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Number of operating segments 1
v3.24.3
GOING CONCERN AND OTHER UNCERTAINTIES (Details) - USD ($)
shares in Thousands, $ in Thousands
 9 Months Ended
Sep. 30, 2024
May 02, 2024
Dec. 31, 2023
Sep. 30, 2023
Liquidity, Going Concern, and Other Uncertainties [Line Items]        
Cash and cash equivalents $ 5,768   $ 16,189 $ 19,184
Public Ventures, LLC | Private Placement        
Liquidity, Going Concern, and Other Uncertainties [Line Items]        
Sale of stock, maximum amount authorized   $ 17,000    
Shares issued in at the market (ATM) (in shares) 50      
Sale of stock, available for issuance under the ATM $ 16,900      
v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) - USD ($)
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Dec. 31, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]          
Restricted cash (included in other assets) $ 56,000 $ 25,000 $ 56,000 $ 25,000 $ 50,000
Property and equipment, net $ 457,000   $ 457,000   256,000
Incremental common shares attributable to dilutive effect of equity forward agreements (in shares) 178,533 176,105 178,533 176,105  
Tools, Dies and Molds          
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]          
Capitalized tools $ 52,200   $ 52,200    
Depreciated based on useful life 7 years   7 years    
Machinery and Equipment          
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]          
Property and equipment, net $ 51,600   $ 51,600    
Construction in Progress          
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]          
Property and equipment, net $ 405,000   $ 405,000   $ 256,000
v3.24.3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share (Details) - shares
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Antidilutive securities excluded from computation of earnings per share (in shares) 12,679,983 10,156,048 12,679,983 10,156,048
Stock options (excluding exercisable penny stock options)        
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Antidilutive securities excluded from computation of earnings per share (in shares) 7,244,175 4,782,020 7,244,175 4,782,020
Restricted stock units        
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Antidilutive securities excluded from computation of earnings per share (in shares) 283,411 221,631 283,411 221,631
Warrants        
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]        
Antidilutive securities excluded from computation of earnings per share (in shares) 5,152,397 5,152,397 5,152,397 5,152,397
v3.24.3
STOCKHOLDERS’ EQUITY - Schedule of Warrant Activity (Details) - USD ($)
$ / shares in Units, $ in Thousands
 9 Months Ended 12 Months Ended
Sep. 30, 2024
Dec. 31, 2023
Number of shares    
Outstanding, beginning balance (in shares) 5,152,397  
Exercisable beginning balance (in shares) 5,152,397  
Exercised (in shares) 0  
Expired (in shares) 0  
Outstanding, ending balance (in shares) 5,152,397 5,152,397
Exercisable ending balance (in shares) 5,152,397 5,152,397
Weighted average exercise price    
Outstanding, beginning balance (in dollars per share) $ 4.71  
Exercisable beginning balance ( in dollars per share) 4.71  
Exercised (in dollars per share) 0  
Expired (in dollars per share) 0  
Outstanding, ending balance (in dollars per share) 4.71 $ 4.71
Exercisable ending balance ( in dollars per share) $ 4.71 $ 4.71
Weighted average remaining life (years)    
Outstanding 2 years 7 months 2 days 3 years 4 months 6 days
Exercisable 2 years 7 months 2 days 3 years 4 months 6 days
Aggregate intrinsic value (in thousands)    
Outstanding $ 742 $ 792
Exercisable $ 742 $ 792
v3.24.3
STOCK-BASED COMPENSATION - Narrative (Details) - USD ($)
$ in Millions
 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Jun. 30, 2024
May 31, 2024
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Cost not yet recognized, options, amount $ 8.3      
Cost not yet recognized, excluding options, amount $ 0.5      
Stock options        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Cost not yet recognized, period of recognition (in years) 2 years 10 months 24 days      
RSU’s        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Cost not yet recognized, period of recognition (in years) 10 months 6 days      
Executives And Employees        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Number of options granted (in shares)   2,208,000    
Executives And Employees | Share-Based Payment Arrangement, Tranche Two        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Percentage of share-based compensation arrangement vesting (as a percent)   40.00%    
Vesting period   48 months    
Executives And Employees | Stock options | Share-Based Payment Arrangement, Tranche One        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Percentage of share-based compensation arrangement vesting (as a percent)   60.00%    
2022 Equity Plan        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Number of shares authorized for issuance (in shares)     8,900,000 5,900,000
v3.24.3
STOCK-BASED COMPENSATION - Schedule of Stock Option, Activity (Details)
$ / shares in Units, $ in Thousands
 9 Months Ended 12 Months Ended
Sep. 30, 2024
USD ($)
$ / shares
shares
Dec. 31, 2023
USD ($)
$ / shares
shares
Number of options outstanding    
Beginning balance (in shares) | shares 6,092,525  
Options granted (in shares) | shares 1,435,000  
Options exercised (in shares) | shares (38,069)  
Options cancelled (in shares) | shares (66,748)  
Ending balance (in shares) | shares 7,422,708 6,092,525
Weighted average exercise price    
Beginning balance (in dollars per share) | $ / shares $ 2.22  
Options granted (in dollars per share) | $ / shares 2.32  
Options exercised (in dollars per share) | $ / shares 0.77  
Options cancelled (in dollars per share) | $ / shares 3.54  
Ending balance (in dollars per share) | $ / shares $ 2.24 $ 2.22
Stock Options Additional Disclosures    
Average remaining contractual life 8 years 7 months 6 days 8 years 8 months 12 days
Aggregate intrinsic value, outstanding | $ $ 2,826 $ 2,945
Exercisable (in shares) | shares 2,147,402  
Exercisable, Weighted average exercise price (in dollars per share) | $ / shares $ 1.96  
Exercisable, Average remaining contractual life 7 years 6 months  
Exercisable, Aggregate intrinsic value | $ $ 1,534  
v3.24.3
STOCK-BASED COMPENSATION - Schedule of Assumptions (Details) - Stock options - USD ($)
 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]    
Risk-free rate, minimum 3.59% 3.54%
Risk-free rate, maximum 4.60% 3.95%
Expected dividend yield $ 0 $ 0
Minimum    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]    
Volatility 125.33% 110.23%
Expected term (in years) 6 years 5 years 10 months 6 days
Weighted average grant date fair value per share (in dollars per share) $ 1.81 $ 1.75
Maximum    
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]    
Volatility 128.85% 110.64%
Expected term (in years) 7 years 6 years 25 days
Weighted average grant date fair value per share (in dollars per share) $ 2.48 $ 3.38
v3.24.3
STOCK-BASED COMPENSATION - Schedule of Nonvested Restricted Stock Units Activity (Details) - RSU’s
 9 Months Ended
Sep. 30, 2024
$ / shares
shares
Numbers of Shares  
Non-vested, beginning balance (in shares) | shares 217,881
Shares granted (in shares) | shares 243,357
Shares vested (in shares) | shares (177,827)
Non-vested, ending balance (in shares) | shares 283,411
Weighted Average Grant Date Fair value  
Non-Vested, beginning balance (in dollars per share) | $ / shares $ 3.12
Shares granted (in dollars per share) | $ / shares 2.26
Shares vested (in dollars per share) | $ / shares 3.13
Non-vested, ending balance (in dollars per share) | $ / shares $ 2.38
v3.24.3
STOCK-BASED COMPENSATION - Schedule of Stock-Based Compensation (Details) - USD ($)
 3 Months Ended 9 Months Ended
Sep. 30, 2024
Sep. 30, 2023
Sep. 30, 2024
Sep. 30, 2023
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Total $ 1,053,000 $ 926,300 $ 3,300,000 $ 2,021,400
General and administrative        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Total 709,000 742,500 2,331,000 1,675,100
General and administrative | Stock options        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Total 560,000 589,500 1,898,000 1,352,100
General and administrative | RSU’s        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Total 149,000 153,000 433,000 323,000
Research and development        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Total 344,000 183,800 969,000 346,300
Research and development | Stock options        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Total 334,000 173,600 941,000 336,100
Research and development | RSU’s        
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]        
Total $ 10,000 $ 10,200 $ 28,000 $ 10,200
v3.24.3
RELATED PARTY TRANSACTIONS (Details)
 1 Months Ended 3 Months Ended 9 Months Ended
Apr. 30, 2024
USD ($)
director
shares
Sep. 30, 2024
USD ($)
Sep. 30, 2023
USD ($)
Sep. 30, 2024
USD ($)
shares
Sep. 30, 2023
USD ($)
Dec. 31, 2023
USD ($)
Related Party Transaction [Line Items]            
Due to related party   $ 1,856,000   $ 1,856,000   $ 1,194,000
Number of independent board of directors members | director 1          
Monthly payment $ 5,000          
Options granted (in shares) | shares       1,435,000    
Consulting service fees   2,176,000 $ 2,114,000 $ 6,778,000 $ 6,417,000  
Stock based compensation expense   1,053,000 $ 926,300 3,300,000 $ 2,021,400  
Related Party            
Related Party Transaction [Line Items]            
Due to related party   5,000   5,000   $ 2,000
Options granted (in shares) | shares 70,000          
Consulting service fees   25,700   50,200    
Stock based compensation expense   $ 10,700   $ 20,200    
Related Party | Stock options            
Related Party Transaction [Line Items]            
Vesting period 36 months          
v3.24.3
COMMITMENTS (Details)
 3 Months Ended 9 Months Ended
Jan. 31, 2024
USD ($)
Sep. 30, 2024
USD ($)
Sep. 30, 2023
USD ($)
Sep. 30, 2024
USD ($)
Sep. 30, 2023
USD ($)
Mar. 08, 2024
USD ($)
site
Feb. 01, 2024
Dec. 31, 2023
USD ($)
Mar. 31, 2022
USD ($)
Long-term Purchase Commitment [Line Items]                  
Operating lease, prior notice for cancellation 1 month                
Monthly rent expense $ 1,800                
Lease commenced, initial period             3 years    
Rent expense   $ 5,400 $ 4,000 $ 15,840 $ 12,000        
Research and development   2,893,000 1,623,000 8,165,000 4,788,000        
Accrued liabilities   1,856,000   1,856,000       $ 1,194,000  
Triple Ring Technologies                  
Long-term Purchase Commitment [Line Items]                  
Purchase commitments                 $ 1,700,000
Research and development   100,000 $ 300,000 300,000 $ 800,000        
Remaining commitment   100,000   100,000          
Clinical Research Organization                  
Long-term Purchase Commitment [Line Items]                  
Research and development   100,000   700,000          
Remaining commitment   100,000   100,000          
Amount to be paid to clinical research organization (CRO)           $ 500,000      
Number of planned sites to carrying out the clinical study | site           5      
Research and development expense, expected cost           $ 900,000      
Accrued liabilities   $ 100,000   $ 100,000          
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