QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
State or Other Jurisdiction of Incorporation or Organization | I.R.S. Employer Identification No. | |||||||
Address of Principal Executive Offices | Zip Code |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Large accelerated filer ☐ | Accelerated filer ☐ | ||||
Smaller reporting company | |||||
Emerging growth company |
Page | ||||||||
March 31, 2024 | December 31, 2023 | ||||||||||
Assets | |||||||||||
Current Assets: | |||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Prepaid expenses and other current assets | |||||||||||
Total Current Assets | $ | $ | |||||||||
Property and equipment, net | |||||||||||
Other assets | |||||||||||
Total Assets | $ | ||||||||||
Liabilities and Stockholders’ Equity | |||||||||||
Current Liabilities: | |||||||||||
Accounts payable and accrued expenses (includes related party $ | |||||||||||
Total Liabilities | |||||||||||
Commitments (Note 7) | |||||||||||
Stockholders’ Equity | |||||||||||
Preferred stock - $ | |||||||||||
Common stock - $ | |||||||||||
Additional paid in capital | |||||||||||
Accumulated deficit | ( | ( | |||||||||
Total Stockholders’ Equity | $ | $ | |||||||||
Total Liabilities and Stockholders’ Equity | $ | $ |
Three months ended March 31, | |||||||||||
2024 | 2023 | ||||||||||
Operating Expenses: | |||||||||||
General and administrative | $ | $ | |||||||||
Research and development | |||||||||||
Total operating expenses | |||||||||||
Loss from operations | ( | ( | |||||||||
Other Income | |||||||||||
Interest income | |||||||||||
Total other income | |||||||||||
Loss before provision for income taxes | ( | $ | ( | ||||||||
Income tax provision | $ | $ | |||||||||
Net Loss | $ | ( | $ | ( | |||||||
Net loss per share, basic and diluted | $ | ( | $ | ( | |||||||
Weighted average common shares outstanding, basic and diluted |
Three months ended March 31, 2024 | |||||||||||||||||||||||||||||
Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total Stockholders' Equity | ||||||||||||||||||||||||||
Shares | Amount | ||||||||||||||||||||||||||||
Balance - January 1, 2024 | $ | $ | $ | ( | $ | ||||||||||||||||||||||||
Stock based compensation expense | — | — | — | ||||||||||||||||||||||||||
Net loss | — | — | — | ( | ( | ||||||||||||||||||||||||
Balance – March 31, 2024 | $ | $ | $ | ( | $ |
Three months ended March 31, 2023 | |||||||||||||||||||||||||||||
Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total Stockholders' Deficit | ||||||||||||||||||||||||||
Shares | Amount | ||||||||||||||||||||||||||||
Balance - January 1, 2023 | $ | $ | $ | ( | $ | ||||||||||||||||||||||||
Stock based compensation expense | — | — | — | ||||||||||||||||||||||||||
Sale of Common Stock, net of issuance costs | — | — | |||||||||||||||||||||||||||
Stock issuance upon vesting of restricted stock awards | — | — | — | — | |||||||||||||||||||||||||
Stock issuance upon exercise of Warrants | |||||||||||||||||||||||||||||
Net loss | — | — | — | ( | ( | ||||||||||||||||||||||||
Balance – March 31, 2023 | $ | $ | $ | ( | $ | ( |
Three months ended March 31, | |||||||||||
2024 | 2023 | ||||||||||
Cash Flows From Operating Activities | |||||||||||
Net loss | $ | ( | $ | ( | |||||||
Adjustments to reconcile net loss to net cash used in operating activities | |||||||||||
Stock-based compensation expense | |||||||||||
Changes in operating assets and liabilities: | |||||||||||
Prepaid expenses and other current assets | ( | ||||||||||
Accounts payable and accrued expenses | ( | ||||||||||
Net cash used in operating activities | ( | ( | |||||||||
Cash Flows From Investing Activities | |||||||||||
Purchase of property and equipment | ( | ||||||||||
Net cash used in investing activities | ( | ||||||||||
Cash Flows From Financing Activities | |||||||||||
Proceeds from sale of equity, net of issuance costs | |||||||||||
Proceeds from exercise of warrants | |||||||||||
Net cash provided by financing activities | |||||||||||
Net decrease in cash and restricted cash | ( | ( | |||||||||
Cash, cash equivalents and restricted cash – Beginning of period | |||||||||||
Cash, cash equivalents and restricted cash – Ending of period | $ | $ | |||||||||
Reconciliation of cash, cash equivalents and restricted cash: | |||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Restricted cash (included in other assets) | |||||||||||
Total cash, cash equivalents and restricted cash | $ | $ |
Three months ended March 31, | ||||||||||||||
2024 | 2023 | |||||||||||||
Stock options (excluding exercisable penny stock options) | ||||||||||||||
Restricted stock units | ||||||||||||||
Warrants | ||||||||||||||
Total |
Number of shares | Weighted average exercise price | Weighted average remaining life (years) | Aggregate intrinsic value (in thousands) | ||||||||||||||||||||
Outstanding - December 31, 2023 | $ | ||||||||||||||||||||||
Exercised | — | — | |||||||||||||||||||||
Expired | — | — | |||||||||||||||||||||
Outstanding and exercisable – March 31, 2024 | $ |
Number of options outstanding | Weighted average exercise price | Average remaining contractual life (in years) | Aggregate intrinsic value (in thousands) | ||||||||||||||||||||
Outstanding – December 31, 2023 | $ | $ | |||||||||||||||||||||
Options granted | |||||||||||||||||||||||
Options exercised | |||||||||||||||||||||||
Options cancelled | ( | ||||||||||||||||||||||
Outstanding – March 31, 2024 | |||||||||||||||||||||||
Exercisable – March 31, 2024 | $ | $ |
Three months ended March 31, 2024 | |||||||||||||||||
Numbers of Shares | Weighted Average Grant Date Fair value | ||||||||||||||||
Non-Vested at beginning of period | $ | ||||||||||||||||
Shares granted | |||||||||||||||||
Shares vested | |||||||||||||||||
Non-vested | $ |
Three months ended March 31, | ||||||||||||||
2024 | 2023 | |||||||||||||
General and administrative | ||||||||||||||
Stock options | ||||||||||||||
RSU’s | ||||||||||||||
Total general and administrative | ||||||||||||||
Research and development | ||||||||||||||
Stock options | ||||||||||||||
RSU’s | ||||||||||||||
Total research and development | ||||||||||||||
Total | $ | $ |
For three months ended March 31, | |||||||||||||||||||||||
2024 | 2023 | $ Change | % Change | ||||||||||||||||||||
(In thousands, except percentages) | |||||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
General and administrative | $ | 2,356 | $ | 2,475 | $ | (119) | (5) | % | |||||||||||||||
Research and development | 2,428 | 1,681 | 747 | 44 | % | ||||||||||||||||||
Total operating expenses | 4,784 | 4,156 | 628 | 15 | % | ||||||||||||||||||
Loss from operations | (4,784) | (4,156) | $ | (628) | 15 | % | |||||||||||||||||
Total other income | 178 | 20 | $ | 158 | 790 | % | |||||||||||||||||
Income tax provision | — | — | — | — | % | ||||||||||||||||||
Net loss | $ | (4,606) | $ | (4,136) | $ | (470) | 11 | % |
March 31, 2024 | December 31, 2023 | |||||||||||||
Cash and cash equivalents | $ | 12,638 | $ | 16,189 |
Three months ended March 31, | ||||||||||||||
2024 | 2023 | |||||||||||||
Net cash used in operating activities | $ | (3,463) | $ | (3,114) | ||||||||||
Net cash used in investing activities | (88) | — | ||||||||||||
Net cash provided by financing activities | — | 510 |
Exhibit Number | Description of Exhibit | |||||||
3.1 | ||||||||
3.2 | ||||||||
3.3 | ||||||||
3.4 | ||||||||
31.1 | ||||||||
32.1 | ||||||||
101.INS | XBRL Instance Document+ | |||||||
101.SCH | XBRL Taxonomy Extension Schema Document+ | |||||||
101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document+ | |||||||
101.DEF | XBRL Taxonomy Extension Definition Linkbase Document+ | |||||||
101.LAB | XBRL Taxonomy Extension Label Linkbase Document+ | |||||||
101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document+ | |||||||
104 | Cover 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. |
HEARTBEAM, Inc. | ||||||||
By: | /s/ Branislav Vajdic | |||||||
Name: | Branislav Vajdic | |||||||
Title: | Chief Executive Officer | |||||||
Dated: May 9, 2024 | (Principal Executive and Accounting Officer) | |||||||
Date: May 9, 2024 | By: /s/ Branislav Vajdic | |||||||
Branislav Vajdic | ||||||||
(Chief Executive Officer) | ||||||||
(Principal Executive and Accounting Officer) |
Date: May 9, 2024 | By: /s/ Branislav Vajdic | |||||||
Branislav Vajdic | ||||||||
(Chief Executive Officer) | ||||||||
(Principal Executive and Accounting Officer) |
Condensed Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Current Assets: | ||
Cash and cash equivalents | $ 12,638 | $ 16,189 |
Prepaid expenses and other current assets | 599 | 636 |
Total Current Assets | 13,237 | 16,825 |
Property and equipment, net | 344 | 256 |
Other assets | 54 | 50 |
Total Assets | 13,635 | 17,131 |
Current Liabilities: | ||
Accounts payable and accrued expenses (includes related party $- and $2, respectively) | 1,097 | 1,194 |
Total Liabilities | 1,097 | 1,194 |
Commitments (Note 7) | ||
Stockholders’ Equity | ||
Preferred stock - $0.0001 par value; 10,000,000 authorized; 0 shares outstanding at March 31, 2024 and December 31, 2023 | 0 | 0 |
Common stock - $0.0001 par value $100,000,000 shares authorized; $26,329,032 shares issued and outstanding at March 31, 2024 and December 31, 2023 | 3 | 3 |
Additional paid in capital | 53,966 | 52,759 |
Accumulated deficit | (41,431) | (36,825) |
Total Stockholders’ Equity | 12,538 | 15,937 |
Total Liabilities and Stockholders’ Equity | $ 13,635 | $ 17,131 |
Condensed Balance Sheets (Unaudited) (Parenthetical) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Current Liabilities: | ||
Due to related party | $ 1,097 | $ 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) | 26,329,032 | 26,329,032 |
Common stock, shares outstanding (in shares) | 26,329,032 | 26,329,032 |
Related Party | ||
Current Liabilities: | ||
Due to related party | $ 0 | $ 2 |
Condensed Statements of Operations (Unaudited) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Operating Expenses: | ||
General and administrative | $ 2,356 | $ 2,475 |
Research and development | 2,428 | 1,681 |
Total operating expenses | 4,784 | 4,156 |
Loss from operations | (4,784) | (4,156) |
Other Income | ||
Interest income | 178 | 20 |
Total other income | 178 | 20 |
Loss before provision for income taxes | (4,606) | (4,136) |
Income tax provision | 0 | 0 |
Net Loss | $ (4,606) | $ (4,136) |
Net loss per share, basic (in dollars per share) | $ (0.17) | $ (0.50) |
Net loss per share, diluted (in dollars per share) | $ (0.17) | $ (0.50) |
Weighted average common shares outstanding, basic (in shares) | 26,511,201 | 8,222,416 |
Weighted average common shares outstanding, diluted (in shares) | 26,511,201 | 8,222,416 |
ORGANIZATION AND OPERATIONS |
3 Months Ended |
---|---|
Mar. 31, 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) images of cardiac electrical activity by displaying the spatial locations of ECG waveforms that demonstrated in early studies to deliver equal or superior diagnostic capability than 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 has filed a 510(k) submission in 2023 for 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’s operations are based in Santa Clara, California and operates as one segment.
|
GOING CONCERN AND OTHER UNCERTAINTIES |
3 Months Ended |
---|---|
Mar. 31, 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 March 31, 2024 the Company has a cash and cash equivalents balance of approximately $12.6 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. In February 2023, the Company entered into a sales agreement (the “Sales Agreement”) with A.G.P./Alliance Global Partners (“AGP”) pursuant to which the Company may issue and sell, from time to time, shares of the Company’s common stock having an aggregate offering price of up to $13.0 million in at-the-market offerings (“ATM”) sales, which was terminated in May 2024. On May 2, 2024, the Company entered into a Sales Agreement (“PV Sales Agreement”) with Public Ventures, LLC, as sales agent (“Public Ventures” or “Agent”), pursuant to which the Company may sell up to an aggregate of approximately $17 million of shares of the Company’s common stock. Refer Note 8- Subsequent events. 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. 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. 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.
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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 March 31, 2024 and December 31, 2023.The Company has made a deposit to the bank for their credit cards in the amount of $50,000 and is classified as restricted cash included in other assets as of March 31, 2024. 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. As of March 31, 2024, property and equipment, net represents construction-in-progress of $343,965 related to tooling development that has not been placed into service. 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 months ended March 31, 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. As of March 31, 2024, 182,169 penny options have been included in the calculation of weighted average basic and diluted earnings per share. The following is a summary of awards outstanding as of March 31, 2024 and 2023, which are not included in the computation of basic and diluted weighted average shares:
RECENTLY ISSUED ACCOUNTING STANDARDS Not Yet Adopted as of March 31, 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 does not expect that the updated standard will have a significant impact 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.
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STOCKHOLDERS’ EQUITY |
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STOCKHOLDERS’ EQUITY | STOCKHOLDERS’ EQUITY WARRANTS The following is a summary of warrant activity during the three months ended March 31, 2024:
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Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
STOCK-BASED COMPENSATION | STOCK-BASED COMPENSATION At the March 28, 2024, Board of Directors meeting, the proposal to amend the 2022 Equity Incentive Plan to increase the number of authorized shares from 5,900,000 shares to 8,900,000 shares was approved, which is pending stockholders’ approval during upcoming annual meeting in June 2024. STOCK OPTIONS The following is a summary of stock option activity during the three months ended March 31, 2024:
RESTRICTED STOCK UNITS The following is a summary of RSU’s awards activity:
STOCK BASED COMPENSATION The following is a summary of stock-based compensation expense:
During 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. As of March 31, 2024, total compensation cost not yet recognized related to unvested stock options and unvested RSUs was approximately $7.0 million and $0.2 million, respectively, which is expected to be recognized over a weighted-average period of 2.4 years and 0.95 years, respectively.
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RELATED PARTY TRANSACTIONS |
3 Months Ended |
---|---|
Mar. 31, 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 an executive of the Company has significant influence. The Company incurred de minimis amount of accounting fees from this firm during the three months ended March 31, 2024 and March 31, 2023. 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.
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COMMITMENTS |
3 Months Ended |
---|---|
Mar. 31, 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 months ended March 31, 2024 and 2023, rent expense was approximately $5,000 and $4,000, 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. As of March 31, 2024, the Company has a remaining commitment of $0.3 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 $0.8 million. For the three months ended March 31, 2024 the Company has expensed $0.3 million based on actual services performed by the CRO and clinical sites, of which $0.2 million was accrued at March 31, 2024. As of March 31, 2024, the Company has a remaining commitment of $0.7 million.
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SUBSEQUENT EVENTS |
3 Months Ended |
---|---|
Mar. 31, 2024 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | SUBSEQUENT EVENTS On May 2, 2024, the Company entered into a PV Sales Agreement with Public Ventures, pursuant to which the Company may offer and sell (the “Offering”), from time to time, at its option, through or to Public Ventures, up to an aggregate of approximately $17 million of shares of the Company’s common stock by presenting a Placement Notice, as defined. The Placement Notice will be effective unless and until (i) the Agent declines to accept the terms contained therein for any reason, in its sole discretion, (ii) the entire amount of the Placement Shares thereunder have been sold, (iii) the Company suspends or terminates the Placement Notice or (iv) this agreement has been terminated. The Company and Public Ventures shall have the right, by giving notice, to terminate this Agreement in its sole discretion and Public Ventures may also terminate the agreement if there is a material adverse change to the Company or the financial markets in the judgment of Public Ventures and as defined in the agreement. The Company 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. Currently, the full amount is available for issuance under this ATM. In order to proceed with the PV Sales Agreement, the Company terminated its A.G.P. Sales Agreement.
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) |
3 Months Ended |
---|---|
Mar. 31, 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”).
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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 March 31, 2024 and December 31, 2023.
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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.
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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 months ended March 31, 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 March 31, 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 does not expect that the updated standard will have a significant impact 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.
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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 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 March 31, 2024 and 2023, which are not included in the computation of basic and diluted weighted average shares:
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STOCKHOLDERS’ EQUITY (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Equity [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Warrant Activity | The following is a summary of warrant activity during the three months ended March 31, 2024:
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STOCK-BASED COMPENSATION (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Stock Option, Activity | The following is a summary of stock option activity during the three months ended March 31, 2024:
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Schedule of Nonvested Restricted Stock Units Activity | The following is a summary of RSU’s awards activity:
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Schedule of Stock-Based Compensation | The following is a summary of stock-based compensation expense:
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ORGANIZATION AND OPERATIONS (Details) |
3 Months Ended |
---|---|
Mar. 31, 2024
segment
| |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Number of operating segments | 1 |
GOING CONCERN AND OTHER UNCERTAINTIES (Details) - USD ($) |
May 02, 2024 |
Mar. 31, 2024 |
Dec. 31, 2023 |
Mar. 31, 2023 |
Feb. 28, 2023 |
---|---|---|---|---|---|
Liquidity, Going Concern, and Other Uncertainties [Line Items] | |||||
Cash and cash equivalents | $ 12,638,000 | $ 16,189,000 | $ 990,000 | ||
A.G.P./Alliance Global Partners | Private Placement | |||||
Liquidity, Going Concern, and Other Uncertainties [Line Items] | |||||
Sale of stock, maximum amount authorized | $ 13,000,000 | ||||
Public Ventures, LLC | Private Placement | Subsequent Event | |||||
Liquidity, Going Concern, and Other Uncertainties [Line Items] | |||||
Sale of stock, maximum amount authorized | $ 17,000,000 |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Narrative (Details) - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2024 |
Mar. 31, 2023 |
|
Accounting Policies [Abstract] | ||
Restricted cash (included in other assets) | $ 50,000 | $ 0 |
Construction in progress | $ 343,965 | |
Incremental common shares attributable to dilutive effect of equity forward agreements (in shares) | 182,169 |
STOCKHOLDERS’ EQUITY - Schedule of Warrant Activity (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 12 Months Ended |
---|---|---|
Mar. 31, 2024 |
Dec. 31, 2023 |
|
Number of shares | ||
Outstanding, 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 (in shares) | 5,152,397 | |
Weighted average exercise price | ||
Outstanding, 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 (in dollars per share) | $ 4.71 | |
Weighted average remaining life (years) | ||
Outstanding | 3 years 1 month 6 days | 3 years 4 months 6 days |
Exercisable | 3 years 1 month 6 days | |
Aggregate intrinsic value (in thousands) | ||
Outstanding | $ 508 | $ 792 |
Exercisable | $ 508 |
STOCK-BASED COMPENSATION - Schedule of Nonvested Restricted Stock Units Activity (Details) - RSU’s |
3 Months Ended |
---|---|
Mar. 31, 2024
$ / shares
shares
| |
Numbers of Shares | |
Non-vested, beginning balance (in shares) | shares | 217,881 |
Shares granted (in shares) | shares | 0 |
Shares vested (in shares) | shares | 0 |
Non-vested, ending balance (in shares) | shares | 217,881 |
Weighted Average Grant Date Fair value | |
Non-Vested, beginning balance (in dollars per share) | $ / shares | $ 3.12 |
Shares granted (in dollars per share) | $ / shares | 0 |
Shares vested (in dollars per share) | $ / shares | 0 |
Non-vested, ending balance (in dollars per share) | $ / shares | $ 3.12 |
RELATED PARTY TRANSACTIONS (Details) - USD ($) $ in Thousands |
Mar. 31, 2024 |
Dec. 31, 2023 |
---|---|---|
Related Party Transaction [Line Items] | ||
Due to related party | $ 1,097 | $ 1,194 |
Related Party | ||
Related Party Transaction [Line Items] | ||
Due to related party | $ 0 | $ 2 |
COMMITMENTS (Details) |
3 Months Ended | |||||
---|---|---|---|---|---|---|
Jan. 31, 2024
USD ($)
|
Mar. 31, 2024
USD ($)
|
Mar. 31, 2023
USD ($)
|
Mar. 08, 2024
USD ($)
site
|
Feb. 01, 2024 |
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 | $ 5,000 | $ 4,000 | ||||
Research and development | 2,428,000 | $ 1,681,000 | ||||
Triple Ring Technologies | ||||||
Long-term Purchase Commitment [Line Items] | ||||||
Purchase commitments | $ 1,700,000 | |||||
Remaining commitment | 300,000 | |||||
Clinical Research Organization | ||||||
Long-term Purchase Commitment [Line Items] | ||||||
Remaining commitment | 700,000 | |||||
Amount to be paid to Clinical Research Organization | $ 500,000 | |||||
Number of planned sites to carrying out the clinical study | site | 5 | |||||
Research and development expense, expected cost | 800,000 | |||||
Research and development | 300,000 | |||||
Remaining commitment accrued | $ 200,000 |
SUBSEQUENT EVENTS (Details) - Public Ventures, LLC - Subsequent Event - Private Placement |
May 02, 2024
USD ($)
|
---|---|
Subsequent Event [Line Items] | |
Sale of stock, maximum amount authorized | $ 17,000,000 |
Commission fixed rate | 3.00% |
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