Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2024 | May 13, 2024 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2024 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2024 | |
Current Fiscal Year End Date | --12-31 | |
Entity File Number | 001-35731 | |
Entity Registrant Name | InspireMD, Inc. | |
Entity Central Index Key | 0001433607 | |
Entity Tax Identification Number | 26-2123838 | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 4 Menorat Hamaor St. | |
Entity Address, City or Town | Tel Aviv | |
Entity Address, Country | IL | |
Entity Address, Postal Zip Code | 6744832 | |
City Area Code | (888) | |
Local Phone Number | 776-6204 | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | NSPR | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 24,929,825 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 | |
CURRENT ASSETS: | |||
Cash and cash equivalents | $ 9,389 | $ 9,640 | |
Marketable securities | 24,561 | 29,383 | |
Accounts receivable: | |||
Trade, net | 1,187 | 1,804 | |
Other | 483 | 648 | |
Prepaid expenses | 531 | 578 | |
Inventory | 2,360 | 2,106 | |
TOTAL CURRENT ASSETS | 38,511 | 44,159 | |
NON-CURRENT ASSETS: | |||
Property, plant and equipment, net | 1,186 | 1,060 | |
Operating lease right of use assets | 1,366 | 1,473 | |
Fund in respect of employee rights upon retirement | 965 | 951 | |
TOTAL NON-CURRENT ASSETS | 3,517 | 3,484 | |
TOTAL ASSETS | 42,028 | 47,643 | |
Accounts payable and accruals: | |||
Trade | 659 | 939 | |
Other | 4,218 | 5,081 | |
TOTAL CURRENT LIABILITIES | 4,877 | 6,020 | |
LONG-TERM LIABILITIES- | |||
Operating lease liabilities | 914 | 1,038 | |
Liability for employees rights upon retirement | 1,150 | 1,084 | |
TOTAL LONG-TERM LIABILITIES | 2,064 | 2,122 | |
COMMITMENTS AND CONTINGENT LIABILITIES | |||
TOTAL LIABILITIES | 6,941 | 8,142 | |
EQUITY: | |||
Common stock, par value $0.0001 per share; 150,000,000 shares authorized at March 31, 2024 and December 31, 2023; 23,412,385 and 21,841,215 shares issued and outstanding at March 31, 2024 and December 2023, respectively | 2 | 2 | |
Preferred C shares, par value $0.0001 per share; 1,172,000 shares authorized at March 31, 2024 and December 31, 2023; 1,718 shares issued and outstanding at March 31, 2024 and December 31 2023, respectively | [1] | ||
Additional paid-in capital | 263,618 | 261,000 | |
Accumulated deficit | (228,533) | (221,501) | |
Total equity | 35,087 | 39,501 | |
Total liabilities and equity | $ 42,028 | $ 47,643 | |
[1]Represents an amount less than $1 thousand |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2024 | Dec. 31, 2023 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 23,412,385 | 21,841,215 |
Common stock, shares outstanding | 23,412,385 | 21,841,215 |
Series C Preferred Stock [Member] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 1,172,000 | 1,172,000 |
Preferred stock, shares issued | 1,718 | 1,718 |
Preferred stock, shares outstanding | 1,718 | 1,718 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Income Statement [Abstract] | ||
REVENUES | $ 1,511 | $ 1,239 |
COST OF REVENUES | 1,219 | 866 |
GROSS PROFIT | 292 | 373 |
OPERATING EXPENSES: | ||
Research and development | 2,625 | 1,843 |
Selling and marketing | 1,237 | 788 |
General and administrative | 3,844 | 2,123 |
Total operating expenses | 7,706 | 4,754 |
LOSS FROM OPERATIONS | (7,414) | (4,381) |
FINANCIAL INCOME, net | 382 | 125 |
NET LOSS | $ (7,032) | $ (4,256) |
NET LOSS PER SHARE - basic | $ (0.21) | $ (0.53) |
NET LOSS PER SHARE - diluted | $ (0.21) | $ (0.53) |
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - basic | 34,242,976 | 8,093,340 |
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - diluted | 34,242,976 | 8,093,340 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Equity (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Preferred Stock [Member] Series C Convertible Preferred Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total | |
Balance at Dec. 31, 2022 | $ 1 | [1] | $ 218,977 | $ (201,585) | $ 17,393 | |
Balance, shares at Dec. 31, 2022 | 8,330,918 | 1,718 | ||||
Net loss | (4,256) | (4,256) | ||||
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures | 289 | 289 | ||||
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures, shares | (4,270) | |||||
Balance at Mar. 31, 2023 | $ 1 | [1] | 219,266 | (205,841) | 13,426 | |
Balance, shares at Mar. 31, 2023 | 8,326,648 | 1,718 | ||||
Balance at Dec. 31, 2023 | $ 2 | [2] | 261,000 | (221,501) | 39,501 | |
Balance, shares at Dec. 31, 2023 | 21,841,215 | 1,718 | ||||
Net loss | (7,032) | (7,032) | ||||
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures | 2,618 | 2,618 | ||||
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures, shares | 1,571,170 | |||||
Balance at Mar. 31, 2024 | $ 2 | [2] | $ 263,618 | $ (228,533) | $ 35,087 | |
Balance, shares at Mar. 31, 2024 | 23,412,385 | 1,718 | ||||
[1]Represents an amount less than $1 thousand[2]Represents an amount less than $1 thousand |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Changes in Equity (Unaudited) (Parenthetical) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Statement of Stockholders' Equity [Abstract] | ||
Shares, restricted stock award, forfeited | 75,090 | 4,270 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (7,032) | $ (4,256) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 69 | 55 |
Change in fair value of markable securities, net of interest received | (218) | |
Change in liability for employees rights upon retirement | 66 | 36 |
Other financial expenses | 4 | 22 |
Change in operating right of use asset and operating leasing liability | (25) | (34) |
Share-based compensation expenses | 2,618 | 289 |
Loss on amounts funded in respect of employee rights upon retirement, net | 14 | 23 |
Decrease in interest receivable on short term deposits | 14 | |
Changes in operating asset and liability items: | ||
Decrease in prepaid expenses | 47 | 261 |
Decrease (Increase) in trade receivables | 617 | (383) |
Decrease (Increase) in other receivables | 165 | (97) |
Increase in inventory | (254) | (76) |
Decrease in trade payables | (280) | (52) |
Decrease in other payables | (855) | (633) |
Net cash used in operating activities | (5,064) | (4,831) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of property, plant and equipment | (195) | (25) |
Investment in short-term bank deposits | (2,500) | |
Withdrawal from short-term bank deposits | 7,000 | |
Investments in marketable securities | (1,960) | |
Proceeds from matured marketable securities | 7,000 | |
Amounts funded in respect of employee rights upon retirement | (28) | (26) |
Net cash provided by (used in) investing activities | 4,817 | 4,449 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Net cash provided by (used in) financing activities | ||
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | (4) | (22) |
DECREASE IN CASH AND CASH EQUIVALENTS | (251) | (404) |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD | 9,640 | 4,632 |
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF THE PERIOD | $ 9,389 | $ 4,228 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Pay vs Performance Disclosure [Table] | ||
Net Income (Loss) | $ (7,032) | $ (4,256) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Mar. 31, 2024 | |
Trading Arrangements, by Individual [Table] | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
DESCRIPTION OF BUSINESS
DESCRIPTION OF BUSINESS | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
DESCRIPTION OF BUSINESS | NOTE 1 - DESCRIPTION OF BUSINESS a. General InspireMD, Inc., a Delaware corporation (the “Company”), together with its subsidiaries, is a medical device company focusing on the development and commercialization of its proprietary MicroNet™ stent platform technology for the treatment of complex vascular and coronary disease. MicroNet, a micron mesh sleeve, is wrapped over a stent to provide embolic protection in stenting procedures. The Company’s carotid product (CGuard™ EPS) combines MicroNet and a self-expandable nitinol stent in a single device to treat carotid artery disease. The Company markets its product through distributors in international markets, mainly in Europe. As of the date of issuance of these consolidated financial statements, the Company has the ability to fund its planned operations for at least the next 12 months. However, the Company expects to continue incurring losses and negative cash flows from operations until its product, CGuard™ EPS, reaches commercial profitability. Therefore, in order to fund the Company’s operations until such time that the Company can generate substantial revenues, the Company may need to raise additional funds. b. Risks Related to the Company’s Operations in Israel including the recent attack by Hamas and other terrorist organizations from the Gaza Strip and Israel’s war against them. In October 2023, Israel was attacked by a terrorist organization and entered a state of war. As of the date of these consolidated financial statements, the war in Israel is ongoing and continues to evolve. The Company operations, including its production facility, are located in Israel. Currently, such activities in Israel remain largely unaffected. During the three months ended March 31, 2024, the impact of this war on the Company’s results of operations and financial condition was immaterial, but such impact may increase, which could be material, as a result of the continuation, escalation or expansion of such war. |
BASIS OF PRESENTATION
BASIS OF PRESENTATION | 3 Months Ended |
Mar. 31, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
BASIS OF PRESENTATION | NOTE 2 - BASIS OF PRESENTATION The accompanying unaudited consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements. In the opinion of the Company, the financial statements reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of its financial position as of March 31, 2024 and its results of operations, changes in equity and cash flows for the three months ended March 31, 2024 and 2023. These consolidated financial statements and notes thereto are unaudited and should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2023, as found in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 5, 2024. The results of operations for the three months ended March 31, 2024 are not necessarily indicative of results that could be expected for the entire fiscal year. |
RECENTLY ADOPTED AND ISSUED ACC
RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS | 3 Months Ended |
Mar. 31, 2024 | |
Accounting Changes and Error Corrections [Abstract] | |
RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS | NOTE 3 - RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS Recently adopted accounting pronouncements In August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2020-06 “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40).” This guidance simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. This ASU is effective for the Company for fiscal years beginning after December 15, 2023, and interim periods within those fiscal years. The Company adopted the provisions of this update as of January 1, 2024 with no material impact on its consolidated financial statements. Recently issued accounting pronouncement, not yet adopted 1) In November 2023, the FASB issued ASU 2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures”. This guidance expands public entities segment disclosures primarily by requiring disclosure of significant segment expenses that are regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. Public entities with a single reportable segment are required to provide the new disclosures and all the disclosures required under Accounting Standards Codification (“ASC”) 280. The guidance is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The amendments are required to be applied retrospectively to all prior periods presented in an entity’s financial statements. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements related disclosures. 2) In December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. This guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S. and in foreign jurisdictions. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively. Early adoption is permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures. |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE MEASUREMENTS | NOTE 4 – FAIR VALUE MEASUREMENTS Fair value is based on the price that would be received from the sale of an asset or that would be paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable prices that are based on inputs not quoted on active markets but corroborated by market data. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. The Company’s financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements were as follows: SCHEDULE OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS Total Level 1 Level 2 Level 3 As of March 31, 2024 ($ in thousands) Total Level 1 Level 2 Level 3 Assets: Cash equivalents- Money market funds $ 3,745 $ 3,745 $ - $ - Marketable securities- U.S government bonds $ 24,561 $ - $ 24,561 $ - Total Level 1 Level 2 Level 3 As of December 31, 2023 ($ in thousands) Total Level 1 Level 2 Level 3 Assets: Cash equivalents- Money market funds $ 7,094 $ 7,094 $ - $ - Cash equivalents $ 7,094 $ 7,094 $ - $ - Marketable securities- U.S government bonds $ 29,383 $ - $ 29,383 $ - Marketable securities $ 29,383 $ - $ 29,383 $ - The Company’s debt securities are classified within Level 2 because it uses quoted market prices or alternative pricing sources and models utilizing market observable inputs to determine their fair value. The cost of marketable securities as of March 31, 2024 is $ 23,878 Fair value of financial instruments The carrying amounts of financial instruments included in working capital approximate their fair value due to the relatively short-term maturities of such instruments. As of March 31, 2024, and December 31, 2023, allowance for expected credit loss was immaterial. |
MARKETABLE SECURITIES
MARKETABLE SECURITIES | 3 Months Ended |
Mar. 31, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
MARKETABLE SECURITIES | NOTE 5 - MARKETABLE SECURITIES The following table sets forth the Company’s marketable securities for the indicated period: SCHEDULE OF MARKETABLE SECURITIES March 31, 2023 December 31, 2023 ($ in thousands) U.S government bonds $ 24,561 $ 29,383 Marketable securities $ 24,561 $ 29,383 The following table summarizes the fair value of the Company’s marketable securities classified by maturity as of March 31, 2024, and December 31, 2023: SCHEDULE OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY March 31, 2024 December 31, 2023 ($ in thousands) Amounts maturing within one year $ 23,573 $ 24,523 Amounts maturing after one year through two years 988 4,860 $ 24,561 $ 29,383 The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the three month period ended March 31, 2024: SCHEDULE OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES Three months ended March 31, 2024 ($ in thousands) Balance at beginning of the period $ 29,383 Additions 1,960 Maturity (7,000 ) Interest Received (75 ) Changes in fair value during the period 293 Balance at end of the period 24,561 |
EQUITY
EQUITY | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
EQUITY | NOTE 6 - EQUITY a. As of March 31, 2024, there were 1,718 7,952 10,997 b. As of March 31, 2024, there are 15,254,623 c. As of March 31, 2024, the Company has outstanding warrants to purchase an aggregate of 53,396,008 SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK Number of underlying Exercise Series E Warrants 198,159 $ 27.0000 Series F Warrants 433,878 $ 7.4250 Series G Warrants 1,092,344 $ 10.2300 Series H Warrants 12,914,086 $ 1.3827 Series I Warrants 12,914,078 $ 1.3827 Series J Warrants 12,914,086 $ 1.3827 Series K Warrants 12,914,078 $ 1.3827 Underwriter Warrants 15,299 $ 7.4250 Total Warrants 53,396,008 $ As of March 31, 2024, the Company had 155,000,000 0.0001 150,000,000 5,000,000 d. During the three months ended March 31, 2024, the Company granted 1,634,403 The fair value of the above restricted shares was approximately $ 5.07 During the three months ended March 31, 2024, the Company granted 563,499 The fair value of the above restricted share units was approximately $ 1.77 During the three months ended March 31, 2024, the Company granted to employees and directors options to purchase a total of 715,614 2.71 3.14 In calculating the fair value of the above options, the Company used the following assumptions: dividend yield of 0 5.5 6.5 96.40 119.38 3.93 4.10 The fair value of the above options, using the Black-Scholes option-pricing model, was approximately $ 1.85 |
RELATED PARTIES TRANSACTIONS
RELATED PARTIES TRANSACTIONS | 3 Months Ended |
Mar. 31, 2024 | |
Related Party Transactions [Abstract] | |
RELATED PARTIES TRANSACTIONS | NOTE 7 – RELATED PARTIES TRANSACTIONS During the three months ended March 31, 2024, a member of the immediate family of the CEO provided certain administrative services in connection with the Company’s expansion to the U.S. in the amount of $ 15 |
NET LOSS PER SHARE
NET LOSS PER SHARE | 3 Months Ended |
Mar. 31, 2024 | |
Earnings Per Share [Abstract] | |
NET LOSS PER SHARE | NOTE 8 - NET LOSS PER SHARE Basic and diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of shares of common stock, pre-funded warrants and fully vested restricted stock units outstanding during the period. The calculation of diluted net loss per share excludes the effect of potential dilution of share options, warrants, and unvested restricted stocks, unvested restricted stock units and Series C preferred stock as the effect is anti-dilutive. For the purpose of calculating basic net loss per share, the additional shares of common stock that are issuable upon exercise of the pre-funded warrants have been included since the shares are issuable for a negligible consideration, as determined by the Company according to ASC 260-10-45-13, and have no vesting or other contingencies associated with them. For the three month period ended March 31, 2024, the Company had weighted average pre-funded warrants to purchase 15,254,623 The total number of shares of common stock related to outstanding options, warrants, unvested restricted stock, unvested restricted stock units and Series C preferred stock, which were excluded from the calculations of diluted loss per share were 62,556,668 2,773,675 4,611,500 342,766 |
INVENTORY
INVENTORY | 3 Months Ended |
Mar. 31, 2024 | |
Inventory Disclosure [Abstract] | |
INVENTORY | NOTE 9 - INVENTORY SCHEDULE OF INVENTORIES March 31, 2024 December 31, 2023 ($ in thousands) Finished goods $ 73 $ 210 Work in process 917 562 Raw materials and supplies 1,370 1,334 Total inventory $ 2,360 $ 2,106 |
ACCOUNTS PAYABLE AND ACCRUALS -
ACCOUNTS PAYABLE AND ACCRUALS - OTHER | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
ACCOUNTS PAYABLE AND ACCRUALS - OTHER | NOTE 10 - ACCOUNTS PAYABLE AND ACCRUALS - OTHER SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER March 31, 2024 December 31, 2023 ($ in thousands) Employees and employee institutions 1,207 2,188 Accrued vacation and recreation pay 348 287 Accrued expenses 1,101 1,115 Clinical trial accrual 826 744 Current Operating lease liabilities 549 557 Other 187 190 Accounts Payable and Accruals - Other $ 4,218 $ 5,081 |
DISAGGREGATED REVENUE AND ENTIT
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES | 3 Months Ended |
Mar. 31, 2024 | |
Segment Reporting [Abstract] | |
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES | NOTE 11 - DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES Revenues are attributed to geographic areas based on the location of the customers. The following is a summary of revenues: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS Three months ended March 31 2024 2023 ($ in thousands) Italy $ 295 $ 267 Germany 242 214 Poland 152 119 Other 822 639 $ 1,511 $ 1,239 By principal customers: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS Three months ended March 31 2024 2023 Customer A 16 % 17 % Customer B 12 % 13 % Customer C 10 % 10 % All tangible long lived assets are located in Israel. |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Fair Value Disclosures [Abstract] | |
SCHEDULE OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS | The Company’s financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements were as follows: SCHEDULE OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS Total Level 1 Level 2 Level 3 As of March 31, 2024 ($ in thousands) Total Level 1 Level 2 Level 3 Assets: Cash equivalents- Money market funds $ 3,745 $ 3,745 $ - $ - Marketable securities- U.S government bonds $ 24,561 $ - $ 24,561 $ - Total Level 1 Level 2 Level 3 As of December 31, 2023 ($ in thousands) Total Level 1 Level 2 Level 3 Assets: Cash equivalents- Money market funds $ 7,094 $ 7,094 $ - $ - Cash equivalents $ 7,094 $ 7,094 $ - $ - Marketable securities- U.S government bonds $ 29,383 $ - $ 29,383 $ - Marketable securities $ 29,383 $ - $ 29,383 $ - |
MARKETABLE SECURITIES (Tables)
MARKETABLE SECURITIES (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Investments, Debt and Equity Securities [Abstract] | |
SCHEDULE OF MARKETABLE SECURITIES | The following table sets forth the Company’s marketable securities for the indicated period: SCHEDULE OF MARKETABLE SECURITIES March 31, 2023 December 31, 2023 ($ in thousands) U.S government bonds $ 24,561 $ 29,383 Marketable securities $ 24,561 $ 29,383 |
SCHEDULE OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY | The following table summarizes the fair value of the Company’s marketable securities classified by maturity as of March 31, 2024, and December 31, 2023: SCHEDULE OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY March 31, 2024 December 31, 2023 ($ in thousands) Amounts maturing within one year $ 23,573 $ 24,523 Amounts maturing after one year through two years 988 4,860 $ 24,561 $ 29,383 |
SCHEDULE OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES | The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the three month period ended March 31, 2024: SCHEDULE OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES Three months ended March 31, 2024 ($ in thousands) Balance at beginning of the period $ 29,383 Additions 1,960 Maturity (7,000 ) Interest Received (75 ) Changes in fair value during the period 293 Balance at end of the period 24,561 |
EQUITY (Tables)
EQUITY (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Equity [Abstract] | |
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK | SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK Number of underlying Exercise Series E Warrants 198,159 $ 27.0000 Series F Warrants 433,878 $ 7.4250 Series G Warrants 1,092,344 $ 10.2300 Series H Warrants 12,914,086 $ 1.3827 Series I Warrants 12,914,078 $ 1.3827 Series J Warrants 12,914,086 $ 1.3827 Series K Warrants 12,914,078 $ 1.3827 Underwriter Warrants 15,299 $ 7.4250 Total Warrants 53,396,008 $ |
INVENTORY (Tables)
INVENTORY (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Inventory Disclosure [Abstract] | |
SCHEDULE OF INVENTORIES | SCHEDULE OF INVENTORIES March 31, 2024 December 31, 2023 ($ in thousands) Finished goods $ 73 $ 210 Work in process 917 562 Raw materials and supplies 1,370 1,334 Total inventory $ 2,360 $ 2,106 |
ACCOUNTS PAYABLE AND ACCRUALS_2
ACCOUNTS PAYABLE AND ACCRUALS - OTHER (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Payables and Accruals [Abstract] | |
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER | SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER March 31, 2024 December 31, 2023 ($ in thousands) Employees and employee institutions 1,207 2,188 Accrued vacation and recreation pay 348 287 Accrued expenses 1,101 1,115 Clinical trial accrual 826 744 Current Operating lease liabilities 549 557 Other 187 190 Accounts Payable and Accruals - Other $ 4,218 $ 5,081 |
DISAGGREGATED REVENUE AND ENT_2
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES (Tables) | 3 Months Ended |
Mar. 31, 2024 | |
Segment Reporting [Abstract] | |
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS | Revenues are attributed to geographic areas based on the location of the customers. The following is a summary of revenues: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS Three months ended March 31 2024 2023 ($ in thousands) Italy $ 295 $ 267 Germany 242 214 Poland 152 119 Other 822 639 $ 1,511 $ 1,239 |
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS | By principal customers: SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS Three months ended March 31 2024 2023 Customer A 16 % 17 % Customer B 12 % 13 % Customer C 10 % 10 % |
SCHEDULE OF FINANCIAL ASSETS SU
SCHEDULE OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 23,878 | |
Fair Value, Recurring [Member] | US Government Agencies Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 24,561 | $ 29,383 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | US Government Agencies Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | ||
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | US Government Agencies Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | 24,561 | 29,383 |
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | US Government Agencies Debt Securities [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | ||
Fair Value, Recurring [Member] | Money Market Funds [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 3,745 | 7,094 |
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 3,745 | 7,094 |
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | ||
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 3 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents |
FAIR VALUE MEASUREMENTS (Detail
FAIR VALUE MEASUREMENTS (Details Narrative) $ in Thousands | Mar. 31, 2024 USD ($) |
Fair Value Disclosures [Abstract] | |
Cost of marketable securities | $ 23,878 |
SCHEDULE OF MARKETABLE SECURITI
SCHEDULE OF MARKETABLE SECURITIES (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Marketable Securities [Line Items] | ||
Marketable securities | $ 24,561 | $ 29,383 |
US Government Agencies Debt Securities [Member] | ||
Marketable Securities [Line Items] | ||
Marketable securities | $ 24,561 | $ 29,383 |
SCHEDULE OF FAIR VALUE OF MARKE
SCHEDULE OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Investments, Debt and Equity Securities [Abstract] | ||
Amounts maturing within one year | $ 23,573 | $ 24,523 |
Amounts maturing after one year through two years | 988 | 4,860 |
Marketable securities | $ 24,561 | $ 29,383 |
SCHEDULE OF CHANGES IN FAIR VAL
SCHEDULE OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | ||
Balance at beginning of the period | $ 29,383 | |
Additions | 1,960 | |
Maturity | (7,000) | |
Interest Received | (75) | |
Changes in fair value during the period | 293 | |
Balance at end of the period | $ 24,561 |
SCHEDULE OF ISSUANCE OF WARRANT
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK (Details) | Mar. 31, 2024 $ / shares shares |
Class of Stock [Line Items] | |
Total Warrants | 53,396,008 |
Series E Warrants [Member] | |
Class of Stock [Line Items] | |
Total Warrants | 198,159 |
Weighted average exercise price | $ / shares | $ 27 |
Series F Warrants [Member] | |
Class of Stock [Line Items] | |
Total Warrants | 433,878 |
Weighted average exercise price | $ / shares | $ 7.4250 |
Series G Warrants [Member] | |
Class of Stock [Line Items] | |
Total Warrants | 1,092,344 |
Weighted average exercise price | $ / shares | $ 10.2300 |
Series H Warrants [Member] | |
Class of Stock [Line Items] | |
Total Warrants | 12,914,086 |
Weighted average exercise price | $ / shares | $ 1.3827 |
Series I Warrants [Member] | |
Class of Stock [Line Items] | |
Total Warrants | 12,914,078 |
Weighted average exercise price | $ / shares | $ 1.3827 |
Series J Warrants [Member] | |
Class of Stock [Line Items] | |
Total Warrants | 12,914,086 |
Weighted average exercise price | $ / shares | $ 1.3827 |
Series K Warrants [Member] | |
Class of Stock [Line Items] | |
Total Warrants | 12,914,078 |
Weighted average exercise price | $ / shares | $ 1.3827 |
Underwriter Warrants [Member] | |
Class of Stock [Line Items] | |
Total Warrants | 15,299 |
Weighted average exercise price | $ / shares | $ 7.4250 |
EQUITY (Details Narrative)
EQUITY (Details Narrative) - USD ($) | 3 Months Ended | ||
Mar. 31, 2024 | Dec. 31, 2023 | ||
Class of Stock [Line Items] | |||
Preferred stock stated value | [1] | ||
Warrants to purchase common stock | 53,396,008 | ||
Capital stock shares authorized | 155,000,000 | ||
Capital stock par value | $ 0.0001 | ||
Common stock shares authorized | 150,000,000 | 150,000,000 | |
Restricted Stock [Member] | Employees and Directors [Member] | |||
Class of Stock [Line Items] | |||
Shares granted | 1,634,403 | ||
Fair value of shares granted | $ 5,070,000 | ||
Restricted Stock Units (RSUs) [Member] | Chief Executive Officer [Member] | |||
Class of Stock [Line Items] | |||
Shares granted | 563,499 | ||
Fair value of shares granted | $ 1,770,000 | ||
Share-Based Payment Arrangement, Option [Member] | Employees and Directors [Member] | |||
Class of Stock [Line Items] | |||
Share based compensation arrangement by share based payment award options grants in period | 715,614 | ||
Expected dividend rate | 0% | ||
Expected volatility, minimum | 96.40% | ||
Expected volatility, maximum | 119.38% | ||
Fair value stock option price | $ 1,850,000 | ||
Share-Based Payment Arrangement, Option [Member] | Employees and Directors [Member] | Minimum [Member] | |||
Class of Stock [Line Items] | |||
Stock option exercise price | $ 2.71 | ||
Expected term | 5 years 6 months | ||
Risk-free interest rate, maximum | 3.93% | ||
Share-Based Payment Arrangement, Option [Member] | Employees and Directors [Member] | Maximum [Member] | |||
Class of Stock [Line Items] | |||
Stock option exercise price | $ 3.14 | ||
Expected term | 6 years 6 months | ||
Risk-free interest rate, maximum | 4.10% | ||
Pre Funded Warrants [Member] | |||
Class of Stock [Line Items] | |||
Warrants outstanding | 15,254,623 | ||
Warrant [Member] | At The Market Offering [Member] | |||
Class of Stock [Line Items] | |||
Warrants to purchase common stock | 53,396,008 | ||
Preferred Stock Blank Check [Member] | |||
Class of Stock [Line Items] | |||
Preferred stock shares authorized | 5,000,000 | ||
Series C Preferred Stock [Member] | |||
Class of Stock [Line Items] | |||
Preferred stock, shares outstanding | 1,718 | 1,718 | |
Preferred stock convertible shares issuable | 7,952 | ||
Preferred stock stated value | $ 10,997 | ||
Preferred stock shares authorized | 1,172,000 | 1,172,000 | |
[1]Represents an amount less than $1 thousand |
RELATED PARTIES TRANSACTIONS (D
RELATED PARTIES TRANSACTIONS (Details Narrative) $ in Thousands | 3 Months Ended |
Mar. 31, 2024 USD ($) | |
Chief Executive Officer [Member] | |
Administrative services from related party | $ 15 |
NET LOSS PER SHARE (Details Nar
NET LOSS PER SHARE (Details Narrative) - shares | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Weighted average prefunded warrants | 15,254,623 | |
Unvested restricted stock | 4,611,500 | 342,766 |
Series C Preferred Stock [Member] | ||
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] | ||
Diluted loss per share | 62,556,668 | 2,773,675 |
SCHEDULE OF INVENTORIES (Detail
SCHEDULE OF INVENTORIES (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 73 | $ 210 |
Work in process | 917 | 562 |
Raw materials and supplies | 1,370 | 1,334 |
Total inventory | $ 2,360 | $ 2,106 |
SCHEDULE OF ACCOUNTS PAYABLE AN
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER (Details) - USD ($) $ in Thousands | Mar. 31, 2024 | Dec. 31, 2023 |
Payables and Accruals [Abstract] | ||
Employees and employee institutions | $ 1,207 | $ 2,188 |
Accrued vacation and recreation pay | 348 | 287 |
Accrued expenses | 1,101 | 1,115 |
Clinical trial accrual | 826 | 744 |
Current Operating lease liabilities | 549 | 557 |
Other | 187 | 190 |
Accounts Payable and Accruals - Other | $ 4,218 | $ 5,081 |
SCHEDULE OF REVENUES ATTRIBUTED
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 1,511 | $ 1,239 |
ITALY | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 295 | 267 |
GERMANY | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 242 | 214 |
POLAND | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | 152 | 119 |
Other Countries [Member] | ||
Revenues from External Customers and Long-Lived Assets [Line Items] | ||
Revenues | $ 822 | $ 639 |
SCHEDULE OF REVENUES ATTRIBUT_2
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS (Details) - Sales [Member] - Customer Concentration Risk [Member] | 3 Months Ended | |
Mar. 31, 2024 | Mar. 31, 2023 | |
Customer A [Member] | ||
Revenue, Major Customer [Line Items] | ||
Percentage of revenues per major customer | 16% | 17% |
Customer B [Member] | ||
Revenue, Major Customer [Line Items] | ||
Percentage of revenues per major customer | 12% | 13% |
Customer C [Member] | ||
Revenue, Major Customer [Line Items] | ||
Percentage of revenues per major customer | 10% | 10% |