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InspireMD, Inc.

For the period ended Mar 31, 2026. Filed May 7, 2026.

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About 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.

Mar 31, 2026 · Filed May 7, 2026

NSPR$0.71+2.5%Stored close · as of Nov 9, 2026

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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.
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 premarket approval (“PMA”) by the U.S. Food and Drug Administration (“FDA”) on June 23, 2025, and is marketed exclusively in the United States through the Company’s direct salesforce. It also received MDR CE Mark approval on June 12, 2025.
Subsequent to March 31, 2026, the Company announced a voluntary recall in the U.S. for its CGuard® Prime 135 cm carotid stent delivery system, initiated in consultation with the FDA. The Company acted after determining during a controlled launch that the technical success of the delivery system during carotid artery stenting procedures had not met performance expectations. The voluntary action pertained specifically to the CGuard Prime delivery system and did not include the CGuard stent implant. The action was strictly voluntary with no implications to the safety of patients who have previously undergone the procedure to implant a CGuard Prime stent.
In connection with the recall, the Company estimates that the reserves to be recognized are approximately $700,000 for customer returns and approximately $650,000 for inventory impairment and remediation costs.
b.Liquidity
The Company has an accumulated deficit as of March 31, 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.
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 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. On April 8, 2026, the United States and Iran agreed to a two-week ceasefire. 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 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 months ended March 31, 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.

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 March 31, 2026, and its results of operations, changes in equity and cash flows for the three months ended March 31, 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 three months ended March 31, 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.

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, 2026 ($ in thousands)
TotalLevel 1Level 2Level 3
Assets:
Cash equivalents-
Money market funds$7,949$7,949--
Marketable securities-
U.S government bonds$30,208-$30,208-
As of December 31, 2025 ($ 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 March 31, 2026, and December 31,2025 is $30,227 and $45,091 thousand, respectively.

NOTE 5 -MARKETABLE SECURITIES

As of 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 three-month periods ended March 31, 2026, and 2025:

Three months ended March 31,
20262025
($ in thousands)
Balance at beginning of the period$45,272$15,721
Additions-6,909
Maturity(15,000)(9,000)
Interest Received(378)(69)
Changes in fair value during the period314142
Balance at end of the period30,20813,703

NOTE 6 -EQUITY**:**

a.Authorized Capital Stock
As of March 31, 2026, 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.
b.Preferred Stock
As of March 31, 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 March 31, 2026, there are 43,092,107 outstanding pre-funded warrants.
d.Warrants
As of March 31, 2026, the Company has outstanding warrants to purchase an aggregate of 25,828,164 shares of common stock as follows:
Number of underlying Common stockExercise priceExpiration date
Series J Warrants12,914,0861.3827*
Series K Warrants12,914,0781.3827*
Total Warrants25,828,164
*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 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 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 three months ended March 31, 2026, a total of 1,092,344 Series G warrants expired unexercised.

e.Share-Based Compensation
During the three months ended March 31, 2026, the Company granted 3,583,055 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 $5.7 million.
During the three months ended March 31, 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 share units was approximately $1.8 million.

NOTE 7 –RELATED PARTIES TRANSACTIONS

For the three months ended March 31, 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 thousand. 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 39,285,493 shares and 52,233,293 shares for the three-month period ended March 31, 2026 and 2025, respectively. This amount includes unvested restricted stock included in the number of issued and outstanding shares in the amounts of 7,315,673 and 5,671,612 as of March 31, 2026, and 2025, respectively.

For the three months ended March 31, 2026, and 2025, the weighted average number of common stock used in computing net loss per share - basic and diluted was as follows:

Three months ended March 31,
20262025
Weighted average number of common stock39,282,76623,521,534
Weighted average Vested restricted stock units1,426,966725,292
Weighted average Pre-funded Warrants43,092,10725,746,683
Total Weighted average number of common stock used in computing net loss per share - basic and diluted83,801,83949,993,509

NOTE 9 -FINANCIAL INSTRUMENTS:

a.Fair value of financial instruments

As of March 31, 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 March 31, 2026, and December 31, 2025, the allowance for expected credit loss was immaterial.

NOTE 10 -INVENTORY:

March 31,December 31,
20262025
($ in thousands)
Finished goods543$352
Work in process903930
Raw materials and supplies1,5902,114
Total inventory3,036$3,396

NOTE 11 -ACCOUNTS PAYABLE AND ACCRUALS - OTHER:

March 31,December 31,
20262025
($ in thousands)
Employees and employee institutions$2,881$4,925
Accrued vacation and recreation pay543430
Accrued expenses1,1461,545
Clinical trial accrual1,5191,155
Current Operating lease liabilities1,0671,066
Other333336
Accounts Payable and Accruals - Other$7,489$9,457

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:

20262025
($ in thousands)
USA1,178$27
Italy354262
Poland301226
Germany255242
Other*1,310772
Revenues3,398$1,529
*Other countries don’t exceed 10% in the three months ended March 31, 2026, and 2025.

By principal customers (part of revenues):

20262025
Customer A8%16%
Customer B9%15%

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 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.

Three months ended March 31,
20262025
Revenues3,3981,529
Cost of Revenues:
Material and Labor1,6911,025
Other cost of revenues1,020212
Total Cost of Revenues2,7111,237
Research and development (R&D)
Payroll and Benefits1,600855
Share based compensation175668
Clinical trials1,4591,160
Other R&D1,5291,376
Total Research and development4,7634,059
Selling and marketing (S&M)
Payroll and Benefits3,8631,979
Share based compensation581217
Other S&M736554
Total Selling and marketing5,1802,750
General and administrative (G&A)
Payroll and Benefits1,8071,676
Share based compensation1,2891,779
Other G&A1,6261,488
Total General and administrative4,7224,943
Financial Income, net;289294
Segment net Loss(13,689)(11,166)
ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.