InspireMD, Inc. 10-Q

Item 1. Financial Statements INSPIREMD, INC. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS OF AND FOR THE QUARTER ENDED JUNE 30, 2026 TABLE OF CONTENTS Page CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED): Condensed Consolidated Balance Sheets F-2 - F-3 Condensed Consolidated Statements of Operations F-4 Condensed Consolidated Statements of Changes in Equity F-5 - F-8 Condensed Consolidated Statements of Cash Flows F-9 Notes to the Condensed Consolidated Financial Statements F-10 - F-18 F- 1 INSPIREMD, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (U.S. dollars in thousands, except share and per share data) June 30, December 31, 2026 2025 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 15,149 $ 8,939 Marketable securities 15,272 45,272 Accounts receivable: Trade, net 1,816 2,168 Other 592 400 Prepaid expenses 1,098 1,296 Inventory 2,701 3,396 TOTAL CURRENT ASSETS 36,628 61,471 NON-CURRENT ASSETS: Long term deposit 450 442 Property, plant and equipment, net 3,858 3,584 Operating lease right of use assets 2,428 2,758 Fund in respect of employee rights upon retirement 1,277 1,149 TOTAL NON-CURRENT ASSETS 8,013 7,933 TOTAL ASSETS $ 44,641 $ 69,404 F- 2 INSPIREMD, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (U.S. dollars in thousands except share and per share data) June 30, December 31, 2026 2025 LIABILITIES AND EQUITY CURRENT LIABILITIES: Accounts payable and accruals: Trade 1,654 1,255 Other 7,992 9,457 TOTAL CURRENT LIABILITIES 9,646 10,712 LONG-TERM LIABILITIES Operating lease liabilities net of current maturities 1,969 2,224 Liability for employee rights upon retirement and others 1,515 1,267 TOTAL LONG-TERM LIABILITIES 3,484 3,491 TOTAL LIABILITIES 13,130 14,203 COMMITMENTS AND CONTINGENT LIABILITIES - EQUITY: Common stock, par value $ 0.0001 per share; 250,000,000 and 150,000,000 shares authorized at June 30, 2026 and December 31, 2025, respectively; 46,921,061 and 43,532,281 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively 5 4 Preferred C shares, par value $ 0.0001 per share; 1,172,000 shares authorized at June 30, 2026 and December 31, 2025; 1,718 shares issued and outstanding at June 30, 2026 and December 31 2025 - * - * Additional paid-in capital 361,811 357,489 Accumulated deficit ( 330,305 ) ( 302,292 ) Total equity 31,511 55,201 Total liabilities and equity $ 44,641 $ 69,404 * Represents an amount less than $1 thousand The accompanying notes are an integral part of the condensed consolidated financial statements. F- 3 INSPIREMD, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (U.S. dollars in thousands, except share and per share data) 2026 2025 2026 2025 Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 REVENUES $ 1,771 $ 1,778 $ 5,169 $ 3,307 COST OF REVENUES 2,545 1,465 5,256 2,702 GROSS PROFIT (LOSS) ( 774 ) 313 ( 87 ) 605 OPERATING EXPENSES: Research and development 4,295 3,834 9,058 7,893 Selling and marketing 5,221 4,172 10,401 6,922 General and administrative 4,155 5,326 8,877 10,269 Total operating expenses 13,671 13,332 28,336 25,084 LOSS FROM OPERATIONS ( 14,445 ) ( 13,019 ) ( 28,423 ) ( 24,479 ) FINANCIAL INCOME (EXPENSE), net: 121 ( 132 ) 410 162 NET LOSS $ ( 14,324 ) $ ( 13,151 ) $ ( 28,013 ) $ ( 24,317 ) NET LOSS PER SHARE - basic and diluted $ ( 0.17 ) $ ( 0.26 ) $ ( 0.33 ) $ ( 0.48 ) WEIGHTED AVERAGE NUMBER OF COMMON STOCK USED IN COMPUTING NET LOSS PER SHARE - basic and diluted 84,659,943 51,003,900 84,236,742 50,508,660 The accompanying notes are an integral part of the condensed consolidated financial statements. F- 4 INSPIREMD, INC. CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (Unaudited) (U.S. dollars in thousands, except share data) Shares Amount Shares Amount capital deficit equity Common stock Preferred C shares Additional paid-in Accumulated Total Shares Amount Shares Amount capital deficit equity BALANCE AT January 1, 2025 26,611,033 3 1,718 - * 289,589 ( 253,506 ) 36,086 Net loss ( 24,317 ) ( 24,317 ) Exercise of pre-funded warrants ** 1,411,553 - * - - - - - * Issuance of common stock, included at the market offering net of $ 22 issuance costs 273,621 - * - - 696 - 696 Exercise of Warrants Series I to common stock, net of $ 109 issuance costs 1,408,752 - * - - 1,838 - 1,838 Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures of 288,207 shares 2,847,929 - * - - 5,940 - 5,940 BALANCE AT June 30, 2025 32,552,888 3 1,718 - * 298,063 ( 277,823 ) 20,243 * Represents an amount less than $1 thousand ** Represents cashless exercise of pre-funded warrants The accompanying notes are an integral part of the condensed consolidated financial statements. F- 5 INSPIREMD, INC. CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (Unaudited) (U.S. dollars in thousands, except share data) Shares Amount Shares Amount capital deficit equity Common stock Preferred C shares Additional paid-in Accumulated Total Shares Amount Shares Amount capital deficit equity BALANCE AT April 1, 2025 29,752,661 3 1,718 - * 293,014 ( 264,672 ) 28,345 Net loss ( 13,151 ) ( 13,151 ) Exercise of pre-funded warrants ** 767,693 - * - - - - - * Exercise of Warrants Series I to common stock, net of $ 109 issuance costs 1,408,752 - * - - 1,838 - 1,838 Exercise of Warrants Series I to common stock, net of issuance costs 1,408,752 - * - - 1,838 - 1,838 Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures of 258,912 shares 623,782 - * - - 3,211 - 3,211 BALANCE AT June 30, 2025 32,552,888 3 1,718 - * 298,063 ( 277,823 ) 20,243 * Represents an amount less than $1 thousand ** Represents cashless exercise of pre-funded warrants The accompanying notes are an integral part of the condensed consolidated financial statements. F- 6 INSPIREMD, INC. CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (Unaudited) (U.S. dollars in thousands, except share data) Shares Amount Shares Amount capital deficit equity Common stock Preferred C shares Additional paid-in Accumulated Total Shares Amount Shares Amount capital deficit equity BALANCE AT January 1, 2026 43,532,281 4 1,718 - * 357,489 ( 302,292 ) 55,201 Net loss ( 28,013 ) ( 28,013 ) Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 336,437 shares 3,388,780 1 - - 4,322 - 4,323 BALANCE AT June 30, 2026 46,921,061 5 1,718 - * 361,811 ( 330,305 ) 31,511 * Represents an amount less than $1 thousand The accompanying notes are an integral part of the condensed consolidated financial statements. F- 7 INSPIREMD, INC. CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (Unaudited) (U.S. dollars in thousands, except share data) Shares Amount Shares Amount capital deficit equity Common stock Preferred C shares Additional paid-in Accumulated Total Shares Amount Shares Amount capital deficit equity BALANCE AT April 1, 2026 46,838,963 4 1,718 - * 359,594 ( 315,981 ) 43,617 Balance 46,838,963 4 1,718 - * 359,594 ( 315,981 ) 43,617 Net loss ( 14,324 ) ( 14,324 ) Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 60,064 shares 82,098 1 - - 2,217 - 2,218 Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures 82,098 1 - - 2,217 - 2,218 BALANCE AT June 30, 2026 46,921,061 5 1,718 - * 361,811 ( 330,305 ) 31,511 Balance 46,921,061 5 1,718 - * 361,811 ( 330,305 ) 31,511 * Represents an amount less than $1 thousand The accompanying notes are an integral part of the condensed consolidated financial statements. F- 8 INSPIREMD, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) (U.S. dollars in thousands) 2026 2025 Six months ended June 30 2026 2025 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ ( 28,013 ) $ ( 24,317 ) Adjustments required to reconcile net loss to net cash used in operating activities: Depreciation 307 205 Change in fair value of marketable securities, net of interest received - ( 155 ) Change in liability for employee rights upon retirement 248 277 Other financial income ( 18 ) ( 58 ) Change in operating right of use asset and operating leasing liability 64 377 Share-based compensation expenses 4,323 5,940 Gains on amounts funded in respect of employee rights upon retirement, net ( 84 ) ( 95 ) Changes in operating assets and liability items: Decrease in prepaid expenses 198 113 Decrease (increase) in trade receivables 352 ( 20 ) Decrease (increase) in other receivables ( 192 ) 186 Decrease (increase) in inventory 695 ( 484 ) Increase in trade payables 399 264 Increase (decrease) in other payables ( 1,511 ) 642 Net cash used in operating activities ( 23,232 ) ( 17,125 ) CASH FLOWS FROM INVESTING ACTIVITIES: Purchase of property, plant and equipment ( 524 ) ( 935 ) Investments in marketable securities - ( 11,749 ) Proceeds from matured marketable securities 30,000 19,760 Amounts funded in respect of employee rights upon retirement ( 44 ) ( 52 ) Net cash provided by investing activities 29,432 7,024 CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from exercise of warrants - 1,947 Proceeds from issuance of shares, net of $ 22 issuance costs - 696 Net cash provided by financing activities - 2,643 EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS 10 51 INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 6,210 ( 7,407 ) BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD 8,939 18,916 BALANCE OF CASH AND CASH EQUIVALENTS AT END OF THE PERIOD $ 15,149 $ 11,509 SUPPLEMENT NON-CASH INVESTING AND FINANCING ACTIVITIES: Issuance Costs not yet paid - 109 Acquisition of right-of-use assets by means of lease liabilities - 994 Non-cash purchase of property and equipment 57 - The accompanying notes are an integral part of the condensed consolidated financial statements. F- 9 INSPIREMD, INC. NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS NOTE 1 - DESCRIPTION OF BUSINESS a. General InspireMD, Inc., a Delaware corporation (the “Company”), together with its subsidiaries in Israel and Germany, is a medical device company specializing in the development and commercialization of products for the treatment of carotid artery disease and other vascular conditions. The Company’s portfolio includes two commercial products based on its proprietary CGuard™ carotid stent technology, designed to provide market-leading embolic protection during and after stenting procedures. A stent is an expandable scaffold-like metallic device placed in an artery to widen the lumen and restore blood flow. The Company’s first product, the CGuard™ Carotid Embolic Prevention System (“CGuard EPS”), integrates a self-expanding nitinol stent with a MicroNet™ mesh sleeve as a single device for carotid artery revascularization. The Company has received CE Mark recertification for CGuard EPS under the EU Medical Device Regulation (“MDR”). The Company’s CGuard EPS previously held CE Mark approval under the former Medical Device Directive (“MDD”). CGuard EPS is marketed in over 30 countries outside the United States, mainly in Europe, through a network of distributors. In the first quarter of 2026, the Company submitted a premarket approval (“PMA”) to the U.S. Food and Drug Administration (“FDA”) for the CGuard EPS. The Company’s second product, the CGuard™ Prime Carotid Stent System (“CGuard Prime”), uses the same stent and MicroNet mesh with a differentiated deployment mechanism. CGuard Prime received PMA by the FDA on June 23, 2025. CGuard Prime also received MDR CE Mark approval on June 12, 2025. In May 2026, the Company announced a voluntary recall in the U.S. of CGuard Prime, initiated in consultation with the FDA after the Company determined during a controlled launch that the technical success rate of its delivery system during CAS procedures did not meet performance expectations. The voluntary action was limited to the CGuard Prime delivery system and did not involve the CGuard stent implant. The Company’s assessment did not identify new safety concerns for patients who had previously received a CGuard implant. As of June 30, 2026, substantially all affected products were returned and credits were issued to customers. The Company recorded approximately $ 734,000 as a reduction of revenue related to these returns. In addition, the Company recorded approximately $ 612,000 of inventory impairment associated with the recall. F- 10 b. Liquidity The Company has an accumulated deficit as of June 30, 2026, as well as a history of net losses and negative operating cash flows. The Company expects to continue incurring losses and negative cash flows from operations until the Company expands its commercial revenue to a scale that funds its commercial resources, development activities and support functions. As a result of these expected losses and negative cash flows from operations, along with the Company’s current cash position, the Company does not have sufficient resources to fund operations for at least the next 12 months. Therefore, there is substantial doubt about the Company’s ability to continue as a going concern. These financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. On July 17, 2026, the Company received a notification letter from the Nasdaq Listing Qualifications notifying the Company that it is not in compliance with the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. Management’s plans include the continued commercialization of the Company’s products and raising capital through the sale of additional equity securities, debt or capital inflows from potential strategic partnerships and exercises of warrants. There are no assurances, however, that the Company will be successful in obtaining the level of financing needed for its operations. If the Company is unsuccessful in commercializing its products and raising capital, it may need to reduce activities, curtail or cease operations. c. Risks Related to the Company’s Operations in Israel On October 7, 2023, Hamas launched a series of attacks on civilian and military targets in Southern Israel and Central Israel, to which the Israel Defense Forces responded. In addition, Iran, Hezbollah and the Houthi movement attacked military and civilian targets in Israel, to which Israel responded, including through increased air and/or ground operations in Lebanon, Syria, Yemen and Iran. Following years of conflict in the region, on October 9, 2025, Israel, Hamas, the United States and other countries in the region agreed to a framework for a ceasefire in Gaza between Israel and Hamas. On February 28, 2026, the United States and Israel launched joint combat operations in Iran to which Iran and Hezbollah responded with ballistic missile and drone attacks on Israel as well as other countries and U.S. military bases in the region. Although the United States and Iran have announced ceasefire and de-escalation arrangements from time to time, including a memorandum of understanding entered into on June 17, 2026 that contemplates the termination of military operations on multiple fronts, hostilities have resumed and may continue or escalate. How long and how severe the current conflicts in Gaza, Northern Israel, Lebanon, Iran or the broader region last and become is unknown at this time and any continued clash among Israel, Hamas, Hezbollah, Iran or other countries or militant groups in the region may escalate in the future into a greater regional conflict. The intensity and duration of the security situation in Israel have been difficult to predict, as are the economic implications on our business and operations and on Israel’s economy in general. As of the date of these condensed consolidated financial statements, conflict continues in parts of the region. The Company’s current manufacturing facility, certain of its key personnel and one of its offices are located in Israel. At this time, these activities remain largely unaffected. During the three and six months ended June 30, 2026 and 2025, 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. F- 11 NOTE 2 - BASIS OF PRESENTATION The accompanying unaudited condensed 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 June 30, 2026, and its results of operations, changes in equity and cash flows for the three and six months ended June 30, 2026, and 2025. These unaudited condensed 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, 2025, as found in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 18, 2026. The results of operations for the six and three months ended June 30, 2026 are not necessarily indicative of results that could be expected for the entire fiscal year. NOTE 3 - RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS Recently issued accounting pronouncement, not yet adopted 1) In November 2024, the FASB issued ASU No. 2024-03 Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40). The ASU improves the disclosures about a public business entity’s expense and provides more detailed information about the types of expenses in commonly presented expense captions. The amendments require that at each interim and annual reporting period an entity will, inter alia, disclose amounts of purchases of inventory, employee compensation, depreciation and amortization included in each relevant expense caption (such as cost of sales, G&A, S&M and research and development) as well as disclosures about selling expenses. The ASU is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating this ASU to determine its impact on the Company’s consolidated financial statements and disclosures. 2) In December 2025, the FASB issued ASU 2025-11, “Interim Reporting (Topic 270) Narrow-Scope Improvements.” The amendments in this Update clarify interim disclosure requirements and the applicability of Topic 270. The objective of the update is to provide clarity about current interim requirements. The amendments in this update also include a disclosure principle that requires entities to disclose events since the end of the last annual reporting period that have a material impact on the entity. The amendments in this ASU are required to be adopted for interim periods within annual reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company does not expect ASU 2025-11 to have a material impact on its consolidated financial statements disclosures. 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. F- 12 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 June 30, 2026 ($ in thousands) Total Level 1 Level 2 Level 3 Assets: Cash equivalents- Money market funds $ 12,182 $ 12,182 $ - $ - Marketable securities- U.S government bonds $ 15,272 $ - $ 15,272 $ - Total Level 1 Level 2 Level 3 As of December 31, 2025 ($ in thousands) Total Level 1 Level 2 Level 3 Assets: Cash equivalents- Money market funds $ 5,116 $ 5,116 $ - $ - Marketable securities- U.S government bonds $ 45,272 $ - $ 45,272 $ - The Company’s cash equivalents, and marketable securities are classified within Level 1 and 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 June 30, 2026, and December 31, 2025, is $ 15,239 and $ 45,091 thousand, respectively. F- 13 NOTE 5 - MARKETABLE SECURITIES As of June 30, 2026, and December 31, 2025, all of the Company’s marketable securities had contractual maturities of less than one year. The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the six-month period ended June 30, 2026, and 2025: SCHEDULE OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES 2026 2025 Six months ended June 30, 2026 2025 ($ in thousands) Balance at beginning of the period $ 45,272 $ 15,721 Additions - 11,749 Maturity ( 30,000 ) ( 19,760 ) Interest received ( 522 ) ( 109 ) Changes in fair value during the period 522 264 Balance at end of the period 15,272 7,865 NOTE 6 - EQUITY : a. Authorized Capital Stock As of June 30, 2026, the Company had 255,000,000 authorized shares of capital stock, par value $ 0.0001 per share, of which 250,000,000 are shares of common stock and 5,000,000 are shares of “blank check” preferred stock. b. Preferred Stock As of June 30, 2026, there were 1,718 shares of Series C preferred stock outstanding, convertible into an aggregate of 7,952 shares of the Company’s common stock, with a total stated value of $ 10,997 . c. Pre-Funded Warrants As of June 30, 2026, there are 43,092,107 outstanding pre-funded warrants. F- 14 d. Warrants As of June 30, 2026, the Company has outstanding warrants to purchase an aggregate of 25,828,164 shares of common stock as follows: SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK Number of underlying Common stock Exercise price Expiration date Series J Warrants 12,914,086 1.3827 * Series K Warrants 12,914,078 1.3827 * Total Warrants 25,828,164 * The Series J Warrants and Series K Warrants have a term of the earlier of (i) May 15, 2028 and (ii) (A) in the case of the Series J Warrants, 20 trading days following the Company’s announcement of receipt of FDA approval for the SwitchGuard and CGuard Prime 80 cm and (B) in the case of the Series K Warrants, 20 trading days following the end of the fourth fiscal quarter after the fiscal quarter in which the first commercial sales of CGuard Prime in the U.S. begins. Following the commencement of the first commercial sales of CGuard Prime in the United States, which occurred during the third fiscal quarter of 2025 in July 2025, the Series K Warrants are scheduled to expire twenty (20) trading days after the end of the fourth fiscal quarter thereafter, which is October 28, 2026. During the six months ended June 30, 2026, a total of 1,092,344 Series G warrants expired unexercised. e. Share-Based Compensation During the six months ended June 30, 2026, the Company granted 3,725,216 restricted shares of the Company’s common stock to employees and directors. The shares granted to employees are subject to a three-year vesting period, with one-third of such awards vesting each year, subject to continued service. The shares granted to directors are subject to a one-year vesting period, subject to continued service. The fair value of the above restricted shares was approximately $ 5.8 million. During the six months ended June 30, 2026, the Company granted 1,114,792 restricted stock units convertible into shares of the Company’s common stock to the Company’s chief executive officer. The restricted stock units are subject to a three-year vesting period, with one-third of such awards vesting each year, subject to continued service. The fair value of the above restricted stock units was approximately $ 1.8 million NOTE 7 – RELATED PARTIES TRANSACTIONS During the three and six months ended June 30, 2025, administrative services provided by a member of the chief executive officer’s immediate family in connection with the Company’s expansion to the U.S. amounted to $ 24 and $ 48 thousand, respectively. The engagement with the related party was terminated in July 2025. 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. 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 38,356,174 and 49,201,359 for the six and three-month periods ended June 30, 2026 and 2025, respectively. This amount includes 6,734,737 and 5,456,724 of unvested restricted stock included in the number of issued and outstanding shares as of June 30, 2026 and 2025, respectively. F- 15 For the six and three months ended June 30, 2026, and 2025, the weighted average number of common stock used in computing net loss per share - basic and diluted was as follows: SCHEDULE OF WEIGHTED AVERAGE NUMBER OF SHARES 2026 2025 2026 2025 Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 Weighted average number of common stock 39,903,736 25,292,694 39,598,447 24,419,172 Weighted average Vested restricted stock units 1,664,100 941,744 1,546,188 834,115 Weighted average Pre-funded Warrants 43,092,107 24,769,462 43,092,107 25,255,373 Total Weighted average number of common stock used in computing net loss per share - basic and diluted 84,659,943 51,003,900 84,236,742 50,508,660 NOTE 9 - FINANCIAL INSTRUMENTS : a. Fair value of financial instruments As of June 30, 2026, and December 31, 2025, the carrying amounts of accounts payable, accounts receivable and other receivables approximate their fair values due to the short-term maturities of these instruments. The carrying amount of the long-term deposit approximates its fair value since it is measured at its present value applying prevailing interest rates. b. As of June 30, 2026, and December 31, 2025, the allowance for expected credit loss was immaterial. NOTE 10- INVENTORY : SCHEDULE OF INVENTORIES June 30, December 31, 2026 2025 ($ in thousands) Finished goods $ 120 $ 352 Work in process 981 930 Raw materials and supplies 1,600 2,114 Total inventory $ 2,701 $ 3,396 * The Company recorded approximately $ 612 thousand of inventory impairment in connection with the voluntary recall during the six months ended June 30, 2026. F- 16 NOTE 11 - ACCOUNTS PAYABLE AND ACCRUALS - OTHER : SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER 2026 2025 June 30, December 31, 2026 2025 ($ in thousands) Employees and employee institutions $ 3,135 $ 4,925 Accrued vacation and recreation pay 716 430 Accrued expenses 1,016 1,545 Clinical trial accrual 1,184 1,155 Current Operating lease liabilities 1,056 1,066 Customer credit balances * 581 2 Other 304 334 Accounts Payable and Accruals - Other $ 7,992 $ 9,457 * Customer credit balances primarily represent credits issued to customers in connection with the voluntary recall of CGuard Prime products (see note 1a). NOTE 12 - 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 2026 2025 2026 2025 Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 ($ in thousands) Germany $ 265 $ 360 $ 520 $ 602 Italy 304 324 658 586 Poland 262 249 563 474 Argentina 180 160 347 180 USA ** ( 351 ) 27 827 54 Other * 1,111 658 2,254 1,411 Revenues $ 1,771 $ 1,778 $ 5,169 $ 3,307 * Other countries do not exceed 10% in the six and three months ended June 30, 2026 and 2025. ** Approximately $ 734 thousand of credits issued in connection with the voluntary recall were deducted from U.S revenues for the three and six months ended June 30, 2026, which resulted in negative net revenues in the United States for the three months ended June 30 (see note 1a). By principal customers (part of revenues): SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS 2026 2025 2026 2025 Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 Customer A 15 % 20 % 10 % 18 % Customer B 13 % 12 % 9 % 12 % Customer C 10 % 9 % 7 % 5 % F- 17 NOTE 13 - SEGMENT INFORMATION The Company has one operating and reporting segment, that develops, manufactures and markets products for the treatment of carotid artery disease and other vascular disease, including the Company’s proprietary CGuard™ stent platform. The Company’s Chief Operating Decision Maker (“CODM”), who is the chief executive officer, evaluates the Company’s performance based on its internal reporting which is consistent with the presentation in the Company’s consolidated financial statements. Accordingly, our CODM uses consolidated net loss to measure segment profit or loss, allocate resources, and assess performance. The CODM examines, within each operational function, the employee salaries including the bonus and share based compensation. In addition, the CODM examines the clinical trials expenses within the research and development operations. SCHEDULE OF SEGMENT REVENUE 2026 2025 2026 2025 Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 Revenues 1,771 1,778 5,169 3,307 Cost of Revenues: Material and Labor 1,631 1,138 3,322 2,163 Other cost of revenues 302 327 849 539 Inventory write-off 612 - 1,085 - Total Cost of Revenues 2,545 1,465 5,256 2,702 Research and development (R&D) Payroll and Benefits 1,282 1,120 2,882 1,974 Share based compensation 435 645 610 1,314 Clinical trials 972 1,125 2,473 2,287 Other R&D 1,606 944 3,093 2,318 Total Research and development 4,295 3,834 9,058 7,893 Selling and marketing (S&M) Payroll and Benefits 3,932 2,779 7,795 4,757 Share based compensation 543 595 1,124 812 Other S&M 746 798 1,482 1,353 Total Selling and marketing 5,221 4,172 10,401 6,922 General and administrative (G&A) Payroll and Benefits 1,365 1,729 3,172 3,309 Share based compensation 1,177 1,920 2,466 3,700 Other G&A 1,613 1,677 3,239 3,260 Total General and administrative 4,155 5,326 8,877 10,269 Financial Income (expenses), net; 121 ( 132 ) 410 162 Segment net loss ( 14,324 ) ( 13,151 ) ( 28,013 ) ( 24,317 ) F- 18