InspireMD, Inc.
For the period ended Sep 30, 2025. Filed Nov 10, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 10, 2025
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
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, 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. | |
| On June 13, 2025, the Company received CE Mark approval under the European Medical Device Regulation for the CGuard Prime carotid stent system. On June 23, 2025, the U.S. Food and Drug Administration (“FDA”) granted premarket application (PMA) approval of the CGuard Prime Carotid Stent System in the United States, and in July 2025, the Company announced the official commercial launch of the CGuard Prime carotid stent system in the United States. In the United States, following FDA approval of the PMA of the CGuard Prime Carotid Stent System, the Company markets and sells its product through a direct sales organization. In addition, the Company also markets and sells its product through distributors in international markets, mainly in Europe. | |
| b. | Liquidity The Company has an accumulated deficit as of September 30, 2025, 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 its product, CGuard™ EPS, reaches commercial profitability. 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. Management’s plans include the continued commercialization of the Company’s product and raising capital through the sale of additional equity securities, debt or capital inflows from strategic partnerships and exercise 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 |
| In October 2023, Israel was attacked by the Hamas terrorist organization and entered a state of war on several fronts. In June 2025, following escalating threats and intelligence reports of imminent attacks, Israel conducted preemptive strikes on military and nuclear infrastructure in Iran. Iran responded with drones and missiles attacks, some of which caused civilian casualties and infrastructure damage. After 12 days of hostilities, a ceasefire between Israel and Iran was reached in June 2025. As of October 9, 2025, Israel and Hamas entered into a ceasefire agreement calling for a permanent end of the war. However, there are no assurances that such agreements will hold. As a result, while the ceasefire marks a potential shift towards stability in the region, the situation remains volatile, and the risk of broader regional escalation involving additional actors persists. As of the date of these consolidated financial statements, conflict continues in parts of the region. The Company’s operations, including its current production facility, are located in Israel. At this time, these activities remain largely unaffected. During the nine and three months ended September 30, 2025 and 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. |
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, all adjustments considered necessary for a fair statement of the results of the interim periods reported herein have been included (consisting only of normal recurring adjustments). These 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, 2024, as found in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 12, 2025. The results of operations for the nine and three months ended September 30, 2025 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 December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“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 and disclosures. |
| 2) | 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 expenses 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 financial statements and disclosures. |
| 3) | In July 2025, the FASB issued Accounting Standards Update 2025-05, Financial Instruments- Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets (“ASU 2025-05”). ASU 2025-05 provides a practical expedient that all entities can use when estimating expected credit losses for current accounts receivable and current contract assets arising from transactions accounted for under ASC 606, Revenue from Contracts with Customers. Under this practical expedient, an entity is allowed to assume that the current conditions it has applied in determining credit loss allowances for current accounts receivable and current contract assets remain unchanged for the remaining life of those assets. ASU 2025-05 is effective for fiscal years beginning after December 15, 2025, and interim reporting periods in those years. Entities that elect the practical expedient and, if applicable, make the accounting policy election are required to apply the amendments prospectively. The Company is currently evaluating the potential impact of this guidance on its consolidated financial statements and 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.
The Company’s financial assets are subject to fair value measurements on a recurring basis and the level of input used in such measurements were as follows:
| Total · Level 1 · Level 2 · Level 3 | ||||||
|---|---|---|---|---|---|---|
| Assets: | ||||||
| Cash equivalents- | ||||||
| Money market funds | $53,889 | $53,889 | $ | - | $ | - |
| Total · Level 1 · Level 2 · Level 3 | |||||||
|---|---|---|---|---|---|---|---|
| Assets: | |||||||
| Cash equivalents- | |||||||
| Money market funds | $6,281 | $6,281 | $ | - | $ | - | |
| Marketable securities- | |||||||
| U.S. government bonds | $15,721 | $ | - | $15,721 | $ | - | |
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 December 31, 2024, is $15,277 thousand. As of September 30, 2025, all marketable securities have matured.
NOTE 5 -MARKETABLE SECURITIES
As of December 31, 2024, all of the Company’s investment in marketable securities had contractual maturity of less than one year.
The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the nine-month period ended September 30, 2025, and 2024:
| Nine months ended September 30, | ||
|---|---|---|
| 2025 | 2024 | |
| ($ in thousands) | ||
| Balance at beginning of the period | $15,721 | 29,383 |
| Additions | 11,749 | 14,444 |
| Maturity | (27,648) | (20,000) |
| Interest received | (109) | (217) |
| Changes in fair value during the period | 287 | 974 |
| Balance at end of the period | - | 24,584 |
The Company elected the fair value option to measure and recognize its investments in debt securities in accordance with Accounting Standards Codification ASC 825, Financial Instruments as the Company managed and evaluated the performance on a fair value basis.
NOTE 6 -EQUITY:
| a. | As of September 30, 2025, 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. |
| b. | As of September 30, 2025, there are 44,092,107 outstanding pre-funded warrants. Prior to June 30, 2025, pre-funded warrants were exercised on a cashless basis; from July 1, 2025 through September 30, 2025, pre-funded warrants were exercised for cash. |
| c. | As of September 30, 2025, the Company has outstanding warrants to purchase an aggregate of 26,935,323 shares of common stock as follows: |
| Number of underlying Common stock | Exercise price | Expiration date | |
|---|---|---|---|
| Series F Warrants | 14,815 | $7.4250 | October 16, 2025 |
| Series G Warrants | 1,092,344 | $10.230 | February 8, 2026 |
| Series J Warrants | 12,914,086 | $1.3827 | * |
| Series K Warrants | 12,914,078 | $1.3827 | * |
| Total Warrants | 26,935,323 | ||
| * | 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 and (B) in the case on 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 the CGuard Carotid Stent System in the United States begins. On October 16, 2025, a total of 14,815 Series F warrants expired. d. Exercise of Series I Warrant Following the Company’s announcement on June 24, 2025, that the FDA approved the PMA of the CGuard Prime Carotid Stent System in the United States, and as of September 30, 2025, an aggregate of 12,914,078 Series I Warrants were exercised into 2,352,393 shares of common stock at an exercise price of $1.3827 per share and 10,561,685 pre- funded warrants at an exercise price of $1.3826 per pre-funded warrant, resulting in gross proceeds of approximately $17,855 thousand dollars. After deducting issuance costs of $1,000 thousand, the net proceeds amounted to approximately $16,855 thousand. e. Private Placement On July 30, 2025, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with investors pursuant to which the Company issued and sold in a private placement (the “Private Placement Offering) of an aggregate of 6,791,380 shares (the “Private Placement Shares”) of the Company’s common stock, and pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 9,764,804 shares of common stock, at an offering price of $2.42 per Private Placement Share and $2.4199 per Pre-Funded Warrant. The Pre-Funded Warrants are immediately exercisable at an exercise price of $0.0001 per share and will not expire until exercised in full. The Private Placement Offering resulted in gross proceeds to the Company of approximately $40.1 million and closed on August 1, 2025. The issuance costs amounted to $3,084 thousand. f. During the nine months ended September 30, 2025, 718,913 shares of common stock have been sold under the ATM program for total gross proceeds of approximately $1.8 million and total fees of approximately $64 thousand. |
| g. | As of September 30, 2025, the Company had 155,000,000 authorized shares of capital stock, par value $0.0001 per share, of which 150,000,000 are shares of common stock and 5,000,000 are shares of “blank check” preferred stock. |
| h. | During the nine months ended September 30, 2025, the Company granted 3,303,618 restricted shares of the Company’s common stock to employees and directors. The shares to employees are subject to a three-year vesting period, with one-third of such awards vesting each year. The shares to directors are subject to a one-year vesting period. |
The fair value of the above restricted shares was approximately $8.69 million.
During the nine months ended September 30, 2025, the Company granted 558,417 restricted share units of the Company’s common stock to the chief executive officer. The shares are subject to a three-year vesting period, with one-third of such awards vesting each year.
The fair value of the above restricted share units was approximately $1.54 million.
During the nine months ended September 30, 2025, the Company granted to employees and directors options to purchase a total of 1,092,851 shares of the Company’s common stock. The options have exercise prices ranging from $2.24-$2.79 per share, which was the fair market value of the Company’s common stock on the respective dates of the grant. The options to employees are subject to a three-year vesting period, with one-third of such awards vesting each year. The options to directors are subject to a one-year vesting period.
In calculating the fair value of the above options, the Company used the following assumptions: dividend yield of 0% and expected term of 5.5-6.5 years; expected volatility ranging from 75.74%-92.69%; and risk-free interest rate ranging from 3.89%-4.68%.
The fair value of the above options, using the Black-Scholes option-pricing model, was approximately $2.18 million.
NOTE 7 –RELATED PARTIES TRANSACTIONS
During the nine and three months ended September 30, 2024, and 2025, 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 $55 and $25 thousand, for 2024, and $56 and $8 thousand for 2025, respectively. In July 2025, the engagement with the related party was terminated.
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.
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 37,695,155 and 48,619,222 for the nine and three-month periods ended September 30, 2025 and 2024, respectively. This amount includes 5,385,272 and 3,979,486 of unvested restricted stock included in the number of issued and outstanding shares for the nine and three-month periods ended September 30, 2025 and 2024, respectively.
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 nine and three months ended September 30, 2025 and 2024, the weighted average number of ordinary shares used in computing net loss per share - basic and diluted was as follows:
| Three months ended September 30, | Nine months ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Weighted average number of ordinary shares | 33,741,698 | 21,633,309 | 27,560,829 | 20,048,335 |
| Weighted average Vested restricted stock units | 1,121,678 | 536,606 | 931,022 | 348,383 |
| Weighted average Pre-funded Warrants | 38,603,125 | 26,199,497 | 29,753,517 | 19,016,286 |
| Total Weighted average number of ordinary shares used in computing net loss per share - basic and diluted | 73,466,501 | 48,369,412 | 58,245,368 | 39,413,004 |
NOTE 9 –LEASE AGREEMENTS
| 1) | On May 18, 2025, the Company took possession of Suite 280 at its U.S. headquarters in Miami, Florida, following the landlord’s completion of construction. This date represents the commencement of the lease for Suite 280, in accordance with the terms of the U.S. Lease. In connection with the commencement, the Company recognized an increase of 302 thousand dollars in both operating lease right-of-use assets and operating lease liabilities. |
| 2) | On May 28, 2025, the Company amended the Israeli Lease, extending the lease term through December 31, 2028, and leasing additional space within the facility. The amendment resulted in an increase of 692 thousand dollars to the Company’s operating lease right-of-use assets and lease liabilities to reflect the extended lease term and additional leased area. |
NOTE 10 -FINANCIAL INSTRUMENTS:
| a. | Fair value of financial instruments |
The carrying amounts of financial instruments approximate their fair value either because these amounts are presented at fair value, due to the relatively short-term maturities of certain instruments or they are measured using interest rates close to prevailing market rates.
| b. | As of September 30, 2025, and December 31, 2024, allowance for expected credit loss was immaterial. |
NOTE 11- INVENTORY:
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| ($ in thousands) | ||
| Finished goods | $576 | $18 |
| Work in process | 733 | 638 |
| Raw materials and supplies | 2,298 | 1,914 |
| Total inventory | $3,607 | $2,570 |
NOTE 12 -ACCOUNTS PAYABLE AND ACCRUALS - OTHER:
| September 30, | December 31, | |
|---|---|---|
| 2025 | 2024 | |
| ($ in thousands) | ||
| Employees and employee institutions | 5,357 | 3,414 |
| Accrued vacation and recreation pay | 683 | 369 |
| Accrued expenses | 735 | 1,325 |
| Clinical trials accrual | 1,013 | 519 |
| Current Operating lease liabilities | 1,006 | 542 |
| Other | 269 | 255 |
| Accounts Payable and Accruals - Other | 9,063 | 6,424 |
NOTE 13 -DISAGGREGATED REVENUE:
Revenues are attributed to geographic areas based on the location of the customers. The following is a summary of revenues:
| Three months ended September 30, | Nine months ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| ($ in thousands) | ||||
| USA | 497 | 7 | 551 | 29 |
| Germany | 380 | 306 | 982 | 855 |
| Italy | 293 | 306 | 878 | 865 |
| Poland | 211 | 176 | 686 | 534 |
| Russia | - | 190 | - | 375 |
| Other* | 1,142 | 825 | 2,733 | 2,402 |
| Revenues | $2,523 | $1,810 | $5,830 | $5,060 |
| * | Other individual countries do not exceed 10% in the nine and three months ended September 30, 2025 and 2024. |
|---|
By principal customers:
| Three months ended September 30, | Nine months ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Customer A | 15% | 17% | 17% | 17% |
| Customer B | 8% | 10% | 12% | 11% |
| Customer C | - | 11% | - | 7% |
| Customer D | 8% | 10% | 9% | 9% |
NOTE 14 –SEGMENT INFORMATION
The Company hasone 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 CEO 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 income 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.
| Three months ended September 30, | Nine months ended September 30, | |||
|---|---|---|---|---|
| 2025 | 2024 | 2025 | 2024 | |
| Revenues | 2,523 | 1,810 | 5,830 | 5,060 |
| Cost of Revenues: | ||||
| Material and Labor | 1,391 | 1,209 | 3,554 | 3,373 |
| Other cost of revenues | 268 | 187 | 807 | 650 |
| Total Cost of Revenues | 1,659 | 1,396 | 4,361 | 4,023 |
| Research and development (R&D) | ||||
| Payroll and Benefits | 1,089 | 715 | 3,063 | 2,066 |
| Share based compensation | 576 | 644 | 1,889 | 1,795 |
| Clinical trials | 1,105 | 1,289 | 3,401 | 3,240 |
| Other R&D | 865 | 1,267 | 3,175 | 2,840 |
| Total Research and development | 3,635 | 3,915 | 11,528 | 9,941 |
| Selling and marketing (S&M) | ||||
| Payroll and Benefits | 2,975 | 907 | 7,732 | 2,522 |
| Share based compensation | 567 | 277 | 1,379 | 791 |
| Other S&M | 850 | 288 | 2,203 | 841 |
| Total Selling and marketing | 4,392 | 1,472 | 11,314 | 4,154 |
| General and administrative (G&A) | ||||
| Payroll and Benefits | 1,707 | 889 | 5,015 | 2,539 |
| Share based compensation | 2,351 | 1,460 | 6,051 | 4,970 |
| Other G&A | 1,830 | 1,140 | 5,091 | 3,569 |
| Total General and administrative | 5,888 | 3,489 | 16,157 | 11,078 |
| Financial Income, net; | 343 | 572 | 505 | 1,305 |
| Segment net Loss | (12,708) | (7,890) | (37,025) | (22,831) |
NOTE 15 –SUBSEQUENT EVENTS
Subsequent to September 30, 2025, the Company granted an aggregate of 451,853 restricted shares of the Company’s common stock to employees, directors and consultants. Of these,360,185 shares of common stock granted to employees and consultants are subject to a three-year vesting period, with one-third of such awards vesting each year,48,000 shares of common stock granted to directors are subject to a one-year vesting period and the remaining 43,668 shares granted to a consultant are fully vested
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.