InspireMD, Inc.
For the period ended Mar 31, 2025. Filed May 8, 2025.
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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.
Mar 31, 2025 · Filed May 8, 2025
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Notes to the condensed Consolidated Financial Statements
UNAUDITED 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. | |
| The Company markets its product through distributors in international markets, mainly in Europe and is seeking FDA approval for its CGuard Prime carotid stent system to enter the U.S. market. |
| b. | Liquidity The Company has an accumulated deficit as of March 31, 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 condensed consolidated 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 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 In October 2023, Israel was attacked by a terrorist organization and entered a state of war on several fronts. As of the date of these consolidated financial statements, sustained conflict in the region is ongoing and Israel has entered into certain ceasefires, the results of which are uncertain. The Company operations, including its current production facility, are located in Israel. Currently, such activities in Israel remain largely unaffected. |
| During the three months ended March 31, 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. | |
| d. | Risks Related to the Geopolitical and Military Tensions Between Russia and Ukraine in Europe |
| The escalation of geopolitical instability in Russia and Ukraine as well as currency fluctuations in the Russian Ruble has immaterial impact on the Company’s operations, sales, and future growth prospects in that region as for three months ended March 31, 2025. |
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, 2025 and its results of operations, changes in equity and cash flows for the three months ended March 31, 2025 and 2024. 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 three months ended March 31, 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. |
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:
| As of March 31, 2025 ($ in thousands) | ||||
|---|---|---|---|---|
| Total | Level 1 | Level 2 | Level 3 | |
| Assets: | ||||
| Cash equivalents- | ||||
| Money market funds | $5,409 | $5,409 | - | - |
| Marketable securities- | ||||
| U.S government bonds | $13,703 | - | $13,703 | - |
| As of December 31, 2024 ($ in thousands) | |||||||
|---|---|---|---|---|---|---|---|
| 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 March 31, 2025 and December 31,2024 is $13,460 and $15,277 thousand, respectively.
NOTE 5 -MARKETABLE SECURITIES
As of March 31, 2025 and December 31, 2024, all of the Company’s marketable securities had contractual maturities of less than one year. The fair value of these securities was $13.7 million and $15.7 million as of March 31, 2025 and December 31, 2024, respectively.
The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the three-month period ended March 31, 2025 and 2024:
| Three months ended March 31, 2025 | Three months ended March 31, 2024 | |
|---|---|---|
| ($ in thousands) | ||
| Balance at beginning of the period | $15,721 | $29,383 |
| Additions | 6,909 | 1,960 |
| Maturity | (9,000) | (7,000) |
| Interest Received | (69) | (75) |
| Changes in fair value during the period | 142 | 293 |
| Balance at end of the period | $13,703 | $24,561 |
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 manages its portfolio and evaluates the performance on a fair value basis.
NOTE 6 -EQUITY:
| a. | As of March 31, 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 March 31, 2025, there are 25,503,438 outstanding pre-funded warrants. |
| c. | As of March 31, 2025, the Company has outstanding warrants to purchase an aggregate of 40,268,464 shares of common stock as follows: |
| Number of underlying Common stock | Exercise price | Expiration date | |
|---|---|---|---|
| Series F Warrants | 433,878 | $7.4250 | June 5, 2025-October 16, 2025 |
| Series G Warrants | 1,092,344 | $10.230 | February 8, 2026 |
| Series I Warrants | 12,914,078 | $1.3827 | * |
| Series J Warrants | 12,914,086 | $1.3827 | * |
| Series K Warrants | 12,914,078 | $1.3827 | * |
| Total Warrants | 40,268,464 | ||
| * | The Series I Warrants, 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 I Warrants, 20 trading days following the Company’s announcement of receipt of Premarket Approval from the Food and Drug Administration (“FDA”) for the CGuard Prime Carotid Stent System (135 cm), (B) 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 (C) 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. |
As of March 31, 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.
| d. | During the three months ended March 31, 2025, the Company granted 2,253,445 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 $6.22 million. | |
| During the three months ended March 31, 2025, the Company granted 558,417 restricted share units of the Company’s common stock to the chief executive officer. The restricted share units 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 three months ended March 31, 2025, the Company granted to employees and directors options to purchase a total of 848,207 shares of the Company’s common stock. The options have an exercise price of $2.76 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 91.27%-92.69%; and risk-free interest rate ranging from 4.57%-4.68%. | |
| The fair value of the above options, using the Black-Scholes option-pricing model, was approximately $1.81 million. |
NOTE 7 –RELATED PARTIES TRANSACTIONS
During the three months ended March 31, 2025 and 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 $24 thousand and $15 thousand, respectively.
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 52,233,293 and 62,556,668 for the three month period ended March 31, 2025 and 2024. This amount includes 5,671,612 and 4,611,500 of unvested restricted stock included in the number of issued and outstanding shares as of March 31, 2025 and 2024.
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 months ended March 31, 2025 and 2024, the weighted average number of ordinary shares used in computing net loss per share - basic and diluted was as follows:
| March 31, 2025 | March 31, 2024 | |
|---|---|---|
| Weighted average number of ordinary shares | 23,521,534 | 18,800,131 |
| Weighted average Vested restricted stock units | 725,292 | 188,222 |
| Weighted average Pre-funded Warrants | 25,746,683 | 15,254,623 |
| Total Weighted average number of ordinary shares used in computing net loss per share - basic and diluted | 49,993,509 | 34,242,976 |
NOTE 9 -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 March 31, 2025, and December 31, 2024, allowance for expected credit loss was immaterial. |
NOTE 10 -INVENTORY:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| ($ in thousands) | ||
| Finished goods | $54 | $18 |
| Work in process | 823 | 638 |
| Raw materials and supplies | 1,945 | 1,914 |
| Total inventory | $2,822 | $2,570 |
NOTE 11 -ACCOUNTS PAYABLE AND ACCRUALS - OTHER:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| ($ in thousands) | ||
| Employees and employee institutions | $2,493 | $3,414 |
| Accrued vacation and recreation pay | 536 | 369 |
| Accrued expenses | 821 | 1,325 |
| Clinical trial accrual | 890 | 519 |
| Current Operating lease liabilities | 683 | 542 |
| Other | 217 | 255 |
| Accounts Payable and Accruals - Other | $5,640 | $6,424 |
NOTE 12 -DISAGGREGATED REVENUE:
Revenues are attributed to geographic areas based on the location of the customers. The following is a summary of revenues:
| 2025 | 2024 | |
|---|---|---|
| ($ in thousands) | ||
| Italy | $262 | $295 |
| Germany | 242 | 242 |
| Poland | 226 | 152 |
| Other* | 799 | 822 |
| Revenues | $1,529 | $1,511 |
| * | Other countries don’t exceed 10% in the three months ended March 31, 2025 and 2024. |
By principal customers:
| 2025 | 2024 | |
|---|---|---|
| Customer A | 16% | 16% |
| Customer B | 9% | 12% |
| Customer C | 15% | 10% |
NOTE 13 –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 March 31, | ||
|---|---|---|
| 2025 | 2024 | |
| Revenues | 1,529 | 1,511 |
| Cost of Revenues: | ||
| Material and Labor | 1,025 | 974 |
| Other cost of revenues | 212 | 245 |
| Total Cost of Revenues | 1,237 | 1,219 |
| Research and development (R&D) | ||
| Payroll and Benefits | 855 | 683 |
| Share based compensation | 668 | 468 |
| Clinical trials | 1,160 | 784 |
| Other R&D | 1,376 | 690 |
| Total Research and development | 4,059 | 2,625 |
| Selling and marketing (S&M) | ||
| Payroll and Benefits | 1,979 | 822 |
| Share based compensation | 217 | 250 |
| Other S&M | 554 | 165 |
| Total Selling and marketing | 2,750 | 1,237 |
| General and administrative (G&A) | ||
| Payroll and Benefits | 1,676 | 915 |
| Share based compensation | 1,779 | 1,784 |
| Other G&A | 1,488 | 1,145 |
| Total General and administrative | 4,943 | 3,844 |
| Financial Income, net; | 294 | 382 |
| Segment net Loss | (11,166) | (7,032) |
NOTE 14 -SUBSEQUENT EVENTS:
Subsequent to March 31,2025, the Company granted to 348,370 restricted shares of the Company’s common stock to employees. The shares to employees are subject to a three-year vesting period, with one-thirdof such awards vesting each year.
Subsequent to March 31,2025, one of the Company’s investors exercised pre-funded warrants to purchase 767,693 shares of the Company common stock.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.