UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended:
OR
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission
file number:
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction of | (I.R.S. Employer | |
| incorporation or organization) | Identification No.) |
(Address of principal executive offices)
(Zip Code)
(Registrant’s telephone number, including area code)
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days.
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer ☐ | ||
| Smaller
reporting company | ||
| Emerging
growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
☐ No
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
The number of shares of the registrant’s common stock, $ par value, outstanding as of August 4, 2025:
Item 1. Financial Statements
TABLE OF CONTENTS
| Page | ||
| PART I | ||
| Item 1. | Financial Statements | F-1 |
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 3 |
| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 11 |
| Item 4. | Controls and Procedures | 11 |
| PART II | ||
| Item 1. | Legal Proceedings | 11 |
| Item 1A. | Risk Factors | 11 |
| Item 5. | Other Information | 14 |
| Item 6. | Exhibits | 14 |
| 2 |
INSPIREMD, INC.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF AND FOR THE QUARTER ENDED JUNE 30, 2025
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-17 |
| F-1 |
INSPIREMD, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(U.S. dollars in thousands, except share and per share data)
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Marketable securities | ||||||||
| Accounts receivable: | ||||||||
| Trade, net | ||||||||
| Other | ||||||||
| Prepaid expenses | ||||||||
| Inventory | ||||||||
| TOTAL CURRENT ASSETS | ||||||||
| NON-CURRENT ASSETS: | ||||||||
| Long term deposit | ||||||||
| Property, plant and equipment, net | ||||||||
| Operating lease right of use assets | ||||||||
| Funds in respect of employee rights upon retirement | ||||||||
| TOTAL NON-CURRENT ASSETS | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| F-2 |
INSPIREMD, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(U.S. dollars in thousands, except share and per share data)
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| LIABILITIES AND EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Accounts payable and accruals: | ||||||||
| Trade | ||||||||
| Other | ||||||||
| TOTAL CURRENT LIABILITIES | ||||||||
| LONG-TERM LIABILITIES- | ||||||||
| Operating lease liabilities net of current maturities | ||||||||
| Liability for employees’ rights upon retirement and others | ||||||||
| TOTAL LONG-TERM LIABILITIES | ||||||||
| TOTAL LIABILITIES | ||||||||
| COMMITMENTS AND CONTINGENT LIABILITIES | ||||||||
| EQUITY: | ||||||||
| Common stock, par value $ per share; shares authorized at June 30, 2025 and December 31, 2024; and shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | ||||||||
| Preferred C shares, par value $ per share; shares authorized at June 30, 2025 and December 31, 2024; shares issued and outstanding at June 30, 2025 and December 31 2024 | * | * | ||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total equity | ||||||||
| Total liabilities and equity | $ | $ | ||||||
| * |
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)
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| REVENUES | $ | $ | $ | $ | ||||||||||||
| COST OF REVENUES | ||||||||||||||||
| GROSS PROFIT | ||||||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Research and development | ||||||||||||||||
| Selling and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| LOSS FROM OPERATIONS | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| FINANCIAL INCOME (EXPENSE), net: | ( | ) | ||||||||||||||
| NET LOSS | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| NET LOSS PER SHARE - basic and diluted | $ | ) | $ | ) | $ | ) | $ | ) | ||||||||
| WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - basic and diluted | ||||||||||||||||
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)
| Common stock | Preferred C shares | Additional paid-in | Accumulated | Total | ||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | capital | deficit | equity | ||||||||||||||||||||||
| BALANCE AT January 1, 2024 | * | ( | ) | |||||||||||||||||||||||||
| Net loss | ( | ) | ( | ) | ||||||||||||||||||||||||
| Exercise of pre-funded warrants | * | * | ||||||||||||||||||||||||||
| Exercise of Warrants Series H to | ||||||||||||||||||||||||||||
| Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures of shares | * | |||||||||||||||||||||||||||
| BALANCE AT June 30, 2024 | * | ( | ) | |||||||||||||||||||||||||
| * |
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)
| Common stock | Preferred C shares | Additional paid-in | Accumulated | Total | ||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | capital | deficit | equity | ||||||||||||||||||||||
| BALANCE AT April 1, 2024 | * | ( | ) | |||||||||||||||||||||||||
| Net loss | ( | ) | ( | ) | ||||||||||||||||||||||||
| Exercise of pre-funded warrants | * | * | ||||||||||||||||||||||||||
| Exercise of Warrants Series H to | ||||||||||||||||||||||||||||
| Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures of shares | ( | ) | * | |||||||||||||||||||||||||
| BALANCE AT June 30, 2024 | * | ( | ) | |||||||||||||||||||||||||
| * |
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)
| Common stock | Preferred C shares | Additional paid-in | Accumulated | Total | ||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | capital | deficit | equity | ||||||||||||||||||||||
| BALANCE AT January 1, 2025 | * | ( | ) | |||||||||||||||||||||||||
| Net loss | ( | ) | ( | ) | ||||||||||||||||||||||||
| Exercise of pre-funded warrants** | * | * | ||||||||||||||||||||||||||
| Issuance of common stock, included at the market offering net of $ | * | |||||||||||||||||||||||||||
| Exercise of Warrants Series I to common stock, net of $ | * | |||||||||||||||||||||||||||
| Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures of shares | * | |||||||||||||||||||||||||||
| BALANCE AT June 30, 2025 | * | ( | ) | |||||||||||||||||||||||||
| * |
| ** |
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)
| Common stock | Preferred C shares | Additional paid-in | Accumulated | Total | ||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | capital | deficit | equity | ||||||||||||||||||||||
| BALANCE AT April 1, 2025 | | * | ( | ) | ||||||||||||||||||||||||
| Net loss | ( | ) | ( | ) | ||||||||||||||||||||||||
| Exercise of pre-funded warrants** | * | * | ||||||||||||||||||||||||||
| Exercise of Warrants Series I to common stock, net of $ | * | |||||||||||||||||||||||||||
| Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures of shares | * | |||||||||||||||||||||||||||
| BALANCE AT June 30, 2025 | * | ( | ) | |||||||||||||||||||||||||
| * |
| ** |
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)
Six months ended June 30 | ||||||||
| 2025 | 2024 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments required to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | ||||||||
| Changes in fair value of marketable securities, net of interest received | ( | ) | ( | ) | ||||
| Change in liability for employees’ rights upon retirement | ||||||||
| Other financial expenses (income) | ( | ) | ||||||
| Change in operating right of use asset and operating leasing liability | ( | ) | ||||||
| Share-based compensation expenses | ||||||||
| Loss (gain) on amounts funded in respect of employee rights upon retirement, net | ( | ) | ||||||
| Changes in operating asset and liability items: | ||||||||
| Decrease (increase) in prepaid expenses | ( | ) | ||||||
| Decrease (increase) in trade receivables | ( | ) | ||||||
| Decrease in other receivables | ||||||||
| Increase in inventory | ( | ) | ( | ) | ||||
| Increase (decrease) in trade payables | ( | ) | ||||||
| Increase (decrease) in other payables | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Purchase of property, plant and equipment | ( | ) | ( | ) | ||||
| Investments in marketable securities | ( | ) | ( | ) | ||||
| Proceeds from matured marketable securities | ||||||||
| Amounts funded in respect of employee rights upon retirement | ( | ) | ( | ) | ||||
| Net cash provided by investing activities | ||||||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Proceeds from exercise of warrants | ||||||||
| Proceeds from issuance of shares, net of $ | ||||||||
| Net cash provided by financing activities | ||||||||
| EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | ( | ) | ||||||
| INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | ( | ) | ||||||
| BALANCE OF CASH AND CASH EQUIVALENTS AT THE BEGINNING OF THE PERIOD | ||||||||
| BALANCE OF CASH AND CASH EQUIVALENTS AT END OF THE PERIOD | $ | $ | ||||||
| SUPPLEMENT NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||||||||
| Issuance Costs not yet paid | ||||||||
| Acquisition of right-of-use assets by means of lease liabilities | ||||||||
The accompanying notes are an integral part of the 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, 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.
|
| F-10 |
| b. | Liquidity
| |
The Company has an accumulated deficit as of June 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 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.
On July 30, 2025, the Company raised approximately
$
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. In June 2025, following continued nuclear threats and intelligence assessments indicating imminent attacks, Israel launched a preemptive strike targeting military and nuclear infrastructure inside Iran, aiming to disrupt Iran’s ability to coordinate or escalate hostilities and degrade its nuclear capabilities. Iran responded with multiple waves of drones and ballistic missiles targeting Israeli cities. While most were intercepted, some caused civilian casualties and infrastructure damage. The Israeli military conducted further operations against Iranian assets. After 12 days of hostilities, a ceasefire between Israel and Iran was reached in June 2025. However, 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 six and three months ended June 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. | ||
| d. | Risks Related to the Geopolitical and Military Tensions Between Russia and Ukraine in Europe
| |
| The escalation of geopolitical instability in Russia and Ukraine has had an immaterial impact on the Company’s operations, sales, and future growth prospects in that region as for the six and three months ended June 30, 2025 and 2024. |
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 six and three months ended June 30, 2025 are not necessarily indicative of results that could be expected for the entire fiscal year.
| F-11 |
NOTE 3 - RECENTLY 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 June 30, 2025 | ||||||||||||||||
| Total | Level 1 | Level 2 | Level 3 | |||||||||||||
| Assets: | ||||||||||||||||
| Cash equivalents- | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| Marketable securities- | ||||||||||||||||
| U.S government bonds | $ | $ | $ | $ | ||||||||||||
| As of December 31, 2024 | ||||||||||||||||
| Total | Level 1 | Level 2 | Level 3 | |||||||||||||
| Assets: | ||||||||||||||||
| Cash equivalents- | ||||||||||||||||
| Money market funds | $ | $ | $ | $ | ||||||||||||
| Marketable securities- | ||||||||||||||||
| U.S government bonds | $ | $ | $ | $ | ||||||||||||
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, 2025, and December 31, 2024, is $
| F-12 |
NOTE 5 - MARKETABLE SECURITIES
As of June 30, 2025, and December 31, 2024, all of the Company’s 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 six-month period ended June 30, 2025, and 2024:
| Six months ended June 30, | ||||||||
| 2025 | 2024 | |||||||
| ($ in thousands) | ||||||||
| Balance at beginning of the period | $ | |||||||
| Additions | ||||||||
| Maturity | ( | ) | ( | ) | ||||
| Interest received | ( | ) | ( | ) | ||||
| Changes in fair value during the period | ||||||||
| Balance at end of the period | ||||||||
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 June 30, 2025, there were shares of Series C Preferred Stock outstanding, convertible
into an aggregate of shares of the Company’s common stock, with a total stated
value of $ | |
| b. | As
of June 30, 2025, there are | |
| c. | As
of June 30, 2025, the Company has outstanding warrants to purchase an aggregate of |
Number of underlying Common stock | Exercise price | Expiration date | ||||||||
| Series F Warrants | $ | |||||||||
| Series G Warrants | $ | |||||||||
| Series I Warrants | $ | |||||||||
| Series J Warrants | $ | |||||||||
| Series K Warrants | $ | |||||||||
| Total Warrants | ||||||||||
| * |
| F-13 |
During
the six and three months ended June 30, 2025, a total of
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 June 30, 2025, an aggregate of Series I Warrants to purchase shares of common stock at an exercise
price of $
As
of June 30, 2025, the Company had
| d. | During the six months ended June 30, 2025, the Company granted 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 $
During the six months ended June 30, 2025, the Company granted 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 $
During the six months ended June 30, 2025, the Company granted to employees and directors options to purchase a total of shares of the Company’s common stock. The options have exercise prices ranging from $-$ 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 % and expected term of - years; expected volatility ranging from %-%; and risk-free interest rate ranging from %-%.
The fair value of the above options, using the Black-Scholes option-pricing model, was approximately $ million.
NOTE 7 – RELATED PARTIES TRANSACTIONS
During
the six and three months ended June 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 amounts of $
| F-14 |
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 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 and for the six and three-month periods ended June 30, 2025 and 2024, respectively. This amount includes and of unvested restricted stock included in the number of issued and outstanding shares for the six and three-month periods ended June 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.
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Weighted average number of ordinary shares | ||||||||||||||||
| Weighted average Vested restricted stock units | ||||||||||||||||
| Weighted average Pre-funded Warrants | ||||||||||||||||
| Total Weighted average number of ordinary shares used in computing net loss per share - basic and diluted | ||||||||||||||||
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 | |
| 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 |
| F-15 |
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 June 30, 2025, and December 31, 2024, allowance for expected credit loss was immaterial. |
NOTE 11- INVENTORY:
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| ($ in thousands) | ||||||||
| Finished goods | $ | $ | ||||||
| Work in process | ||||||||
| Raw materials and supplies | ||||||||
| $ | $ | |||||||
NOTE 12 - ACCOUNTS PAYABLE AND ACCRUALS - OTHER:
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| ($ in thousands) | ||||||||
| Employees and employee institutions | $ | $ | ||||||
| Accrued vacation and recreation pay | ||||||||
| Accrued expenses | ||||||||
| Clinical trial accrual | ||||||||
| Current Operating lease liabilities | ||||||||
| Other | ||||||||
| $ | $ | |||||||
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 June 30, | Six
months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| ($ in thousands) | ||||||||||||||||
| Germany | $ | $ | $ | $ | ||||||||||||
| Italy | ||||||||||||||||
| Poland | ||||||||||||||||
| Other* | ||||||||||||||||
| $ | $ | $ | $ | |||||||||||||
| * |
By principal customers:
| Three
months ended June 30, | Six
months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Customer A | % | % | % | % | ||||||||||||
| Customer B | % | % | % | % | ||||||||||||
| F-16 |
NOTE 14: SEGMENT INFORMATION
The
Company has
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 June 30, | Six
months ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenues | ||||||||||||||||
| Cost of Revenues: | ||||||||||||||||
| Material and Labor | ||||||||||||||||
| Other cost of revenues | ||||||||||||||||
| Total Cost of Revenues | ||||||||||||||||
| Research and development (R&D) | ||||||||||||||||
| Payroll and Benefits | ||||||||||||||||
| Share based compensation | ||||||||||||||||
| Clinical trials | ||||||||||||||||
| Other R&D | ||||||||||||||||
| Total Research and development | ||||||||||||||||
| Selling and marketing (S&M) | ||||||||||||||||
| Payroll and Benefits | ||||||||||||||||
| Share based compensation | ||||||||||||||||
| Other S&M | ||||||||||||||||
| Total Selling and marketing | ||||||||||||||||
| General and administrative (G&A) | ||||||||||||||||
| Payroll and Benefits | ||||||||||||||||
| Share based compensation | ||||||||||||||||
| Other G&A | ||||||||||||||||
| Total General and administrative | ||||||||||||||||
| Financial Income (expenses), net; | ( | ) | ||||||||||||||
| Segment net Loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
NOTE 15: SUBSEQUENT EVENTS:
Series I Warrants Exercise
Subsequent
to the balance sheet date and prior to the issuance of these financial statements, holders of the Company’s series I warrants exercised
a total of
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) an aggregate of shares
(the “Private Placement Shares”) of the Company’s common stock, and pre-funded warrants (the “Pre-Funded Warrants”)
to purchase up to shares of common stock, at an offering price of $ per Private Placement Share and $ per
Pre-Funded Warrant. The Pre-Funded Warrants will be immediately exercisable at an exercise price of $
On
August 1, 2025, shares of common stock have been sold under the ATM program for total gross proceeds of approximately $
| F-17 |
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the accompanying condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q.
Unless the context requires otherwise, references in this Form 10-Q to the “Company,” “InspireMD,” “we,” “our” and “us” refer to InspireMD, Inc., a Delaware corporation, and its subsidiaries.
Forward-Looking Statements
This Quarterly Report on Form 10-Q contains “forward-looking statements,” which include information relating to future events, future financial performance, strategies, expectations, competitive environment and regulation, including revenue growth. Words such as “may,” “will,” “should,” “could,” “would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements in future tense, identify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Forward-looking statements are based on information we have when those statements are made or our management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to:
| ● | our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; | |
| ● | our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; | |
| ● | the clinical development, commercialization and market acceptance of our products; | |
| ● | whether the clinical trial results for our products will be predictive of real-world results; | |
| ● | an inability to secure and maintain regulatory approvals for the sale of our products; | |
| ● | negative clinical trial results or lengthy product delays in key markets; | |
| ● | our ability to maintain compliance with the Nasdaq listing standards; | |
| ● | our ability to generate significant revenues from our products; | |
| ● | estimates of our expenses, future revenues, capital requirements and our needs for and ability to access sufficient additional financing, including any unexpected costs or delays in the ongoing commercial launch of our products; | |
| ● | our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; | |
| ● | the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; | |
| ● | intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; | |
| ● | entry of new competitors and products and potential technological obsolescence of our products; | |
| ● | inability to carry out research, development and commercialization plans; | |
| ● | loss of a key customer or supplier; | |
| ● | technical problems with our research and products and potential product liability claims; |
| 3 |
| ● | product malfunctions; | |
| ● | price increases for supplies and components; | |
| ● | whether access to our products is achieved in a commercially viable manner and whether our products receive adequate reimbursement by governmental and other third-party payers; | |
| ● | our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; | |
| ● | adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; | |
| ● | the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; | |
| ● | security, political and economic instability in the Middle East that could harm our business, including due to the current security situation in Israel; | |
| ● | current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; and | |
| ● | changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements and the impact of such policies on us, our customers and suppliers, and the global economic environment. |
The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking statements. For a discussion of these and other risks that relate to our business and investing in our common stock, you should carefully review the risks and uncertainties described in this Quarterly Report on Form 10-Q, and those described from time to time in our future reports filed with the Securities and Exchange Commission. The forward-looking statements contained in this Quarterly Report on Form 10-Q are expressly qualified in their entirety by this cautionary statement. We do not undertake any obligation to publicly update any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.
Overview
We are a medical device company focusing on the development and commercialization of products for the treatment of carotid artery disease and other vascular disease, including our proprietary CGuard™ stent platform. On June 23, 2025, CGuard Prime, our next generation carotid artery stenting (“CAS”) stent platform, was granted premarket application (“PMA”) approval the U.S. Food and Drug Administration (“FDA”). A stent is an expandable scaffold-like device, usually constructed of a metallic material, that is inserted into the lumen of an artery to create patency and improved blood flow. A sleeve of MicroNet™ mesh is attached over a stent to provide embolic protection both during and after stenting procedures.
| 4 |
Our CGuard™ carotid embolic prevention system (“CGuard EPS”) combines MicroNet and a unique self-expandable nitinol stent in a single device for use in carotid artery revascularization. Our CGuard EPS originally received CE mark approval under Medical Device Directive 93/42/EEC (“MDD”) in the European Union (“EU”) in March 2013 and was fully launched in Europe in September 2015. Subsequently, we launched CGuard EPS in over 30 countries and on February 3, 2021, we executed a distribution agreement with Chinese partners for the purpose of expanding our presence in the Asian markets. In January 2024, we received CE mark recertification under the EU’s Medical Device Regulation (“MDR”) regulatory framework.
On September 8, 2020, we received approval from the FDA of our Investigation Device Exemption (“IDE”), thereby allowing us to proceed with a pivotal study of our CGuard™ Carotid Stent System, C-GUARDIANS, for prevention of stroke in patients in the United States. C-GUARDIANS was a prospective, multicenter, single-arm, pivotal study to evaluate the safety and efficacy of the CGuard™ Carotid Stent System when used to treat symptomatic and asymptomatic carotid artery stenosis in patients undergoing CAS. The study, which completed enrollment in June 2023, enrolled 316 patients across 24 trial sites in the U.S. and Europe and from April 2023 included deployment of the CGuard stent using CGuard Prime, our next generation CAS stent platform.
The primary endpoint was a composite of: (1) incidence of major adverse events including Death (all-cause mortality), any Stroke, and Myocardial Infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure. All events were adjudicated by an independent clinical events committee. The composite index was compared to a performance goal based on the observed rate of the two components of the primary endpoint from previous pivotal stent trials which are considered industry standard. The performance goal was considered met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is < 11.6% and the p-value is less than 0.025.
In November 2023, we announced positive 30-day follow up results from the C-GUARDIANS trial in which stenting with the CGuard Carotid Stent System in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%, measured from the date of the procedure through 30 days follow-up post-procedure. In May 2024, we announced positive one-year follow up results from the C-GUARDIANS trial, with a rate of 30-day DSMI and ipsilateral stroke between 31 and 365 days of 1.95%.
These data were used to support the PMA submission in September 2024, which was approved by the FDA on June 23, 2025. On June 12, 2025, we received CE Mark approval under the EU’s MDR for the CGuard Prime Embolic Prevention System.
In October 2024, the FDA approved the Company’s IDE to initiate the CGUARDIANS II pivotal study of its CGuard Prime 80cm Carotid Stent System during transcarotid revascularization (TCAR) procedures.
In October 2023, the Centers for Medicare and Medicaid Service (“CMS”) issued its final National Coverage Determination (“NCD”), expanding coverage for both CAS and TCAR to include both asymptomatic and standard risk patients, significantly expanding and supporting the future growth of the U.S. CAS addressable market.
We continue to invest in current and future potential new indications, products and manufacturing enhancements for CGuard that are expected to reduce cost of goods and/or provide the best-in-class performing delivery systems, such as CGuard Prime. In furtherance of our strategy that focuses on establishing the CGuard Carotid Stent System as a viable alternative to vascular surgery, we are developing a new transcarotid artery revascularization (TCAR) system, SwitchGuard™ neuroprotection system (“SwitchGuard NPS”), for transcarotid access and neuro protection. In addition, we intend to explore new indications for CGuard to leverage the advantages of stent design and mesh protection, well suited in labels such as acute stroke with tandem lesions.
We consider our current addressable market for our CGuard Carotid Stent System and SwitchGuard NPS to be both symptomatic and asymptomatic individuals with diagnosed high-grade carotid artery stenosis for whom intervention is preferable to medical (drug) therapy. This group includes not only carotid artery stenting patients but also individuals undergoing carotid endarterectomy, as the two approaches compete for the same patient population. Assuming full penetration of the intervention caseload by CGuard, we estimate that the addressable market for CGuard Carotid Stent System and SwitchGuard NPS is approximately $1.3 billion (source: Health Research International Personal Medical Systems, Inc. September 13, 2021 Results of Update Report on Global Carotid Stenting Procedures and Markets by Major Geography and Addressable Markets and internal estimates). According to this same report and internal estimates, assuming full penetration of treatment for all individuals diagnosed with high-grade carotid artery stenosis, we estimate the total available market for CGuard Carotid Stent System and SwitchGuard NPS to be approximately $9.3 billion, which may grow over time if expanded treatment options such as CGuard Carotid Stent System and SwitchGuard NPS lead to increased patient screening for carotid artery disease.
| 5 |
We were organized in the State of Delaware on February 29, 2008. In October 2024, we established our global headquarters in Miami, Florida to support the anticipated U.S. launch and commercialization of the CGuard Prime carotid stent system.
Recent Developments
PMA approval of the CGuard Prime Carotid Stent System and Commercial Launch in the United States
On June 23, 2025, the FDA granted PMA approval of the CGuard Prime Carotid Stent System in the United States.
Following such approval, in July 2025, we announced the official commercial launch of the the CGuard Prime Carotid Stent System in the United States. In October 2024, we established our global headquarters in Miami, Florida to support the U.S. launch and commercialization of CGuard Prime Carotid Stent System.
CE Mark Approval for CGuard Prime EPS Under European MDR
On June 12 2025, we received CE Mark approval under the EU’s MDR for the CGuard Prime Embolic Prevention System.
Exercise of Series I Warrant s
Following the announcement of the PMA approval of the CGuard Prime Carotid Stent System in the United States, Series I warrants to purchase 12,914,078 shares of common stock were exercised in full into 2,352,393 of shares of common stock and pre-funded warrants to purchase 10,561,685 shares of common stock during June and July 2025. The net proceeds to the Company from the exercise of the Series I Warrants were $16.9 million after deducting placement agent fees. The Series I warrants, each exercisable at $1.3827 per common share and $1.3826 per pre-funded warrant, were issued as part of the private placement financing that the Company consummated on May 15, 2023.
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”) an aggregate of 6,791,380 shares (the “Private Placement Shares”) of 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 Shares 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. Certain of the Company’s directors participated in the Private Placement Offering. The Private Placement Offering closed on August 1, 2025.
Aggregate gross proceeds to the Company in respect of the Private Placement Offering were approximately $40.1 million, before deducting fees payable to the placement agent and other offering expenses payable by the Company.
In connection with the Purchase Agreement, the Company entered into a registration rights agreement (the “Registration Rights Agreement”) pursuant to which the Company is required to file a resale registration statement (the “Registration Statement”) with the Securities and Exchange Commission (the “SEC”) to register for resale the Private Placement Shares and the shares of common stock issuable upon exercise of the Pre-Funded Warrants, within 20 days of the signing date of the Purchase Agreement (the “Signing Date”), and to have such Registration Statement declared effective within 45 days after the Signing Date in the event the Registration Statement is not reviewed by the SEC, or 90 days of the Signing Date in the event the Registration Statement is reviewed by the SEC. The Company will be obligated to pay certain liquidated damages if the Company fails to file the Registration Statement when required, fails to cause the Registration Statement to be declared effective by the SEC when required, or if the Company fails to maintain the effectiveness of the Registration Statement. The Company paid the placement agent for the offering a placement fee equal to 6.0% of the aggregate gross proceeds from the closing of the Private Placement Offering, or approximately $2.4 million, and expense reimbursement of $75,000.
| 6 |
Critical Accounting Policies
A critical accounting policy is one that is both important to the portrayal of our financial condition and results of operation and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Our critical accounting policies are more fully described in both (i) “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” and (ii) Note 2 of the Notes to the Consolidated Financial Statements included in the Annual Report on Form 10-K for the year ended December 31, 2024. There have not been any material changes to such critical accounting policies since December 31, 2024.
The currency of the primary economic environment in which our operations are conducted is the U.S. dollar (“$” or “dollar”).
Results of Operations
Three months ended June 30, 2025, compared to the three months ended June 30, 2024
Revenues. For the three months ended June 30, 2025, revenue increased by $39,000, or 2.3%, to $1,778,000, from $1,739,000 during the three months ended June 30, 2024. Growth in the quarter was driven by continued adoption of our CGuard technology, as well as positive impact of foreign exchange, offset by a decrease in revenues from Russia due to exchange rates implications and certain European distributors managing CGuard inventory levels in anticipation of the CGuard Prime launch in Europe.
With respect to geographical regions, the increase in revenue was primarily attributable to a $113,000 increase in Latin America, a $39,000 increase in Asia, both due to continued adoption of our CGuard technology, and a $11,000 increase in North America due to sales in the United States related to stents used in our CGUARDIANS II pivotal study. This increase was offset by a $121,000 decrease in Europe and a $3,000 decrease in other territories driven by reasons mentioned above.
Gross Profit. For the three months ended June 30, 2025, gross profit (revenue less cost of revenues) decreased by $18,000, or 5.4%, to $313,000, from $331,000 during the three months ended June 30, 2024. This decrease in gross profit resulted from an increase in write-offs and miscellaneous expense of $111,000, partially offset by the gross profit generated from the $93,000 increase in revenue (net of associated material and labor costs). Gross margin (gross profits as a percentage of revenue) decreased to 17.6% during the three months ended June 30, 2025, from 19.0% during the three months ended June 30, 2024, driven by the reasons mentioned above.
Research and Development Expenses. For the three months ended June 30, 2025, research and development expenses increased by $433,000, or 12.7%, to $3,834,000, from $3,401,000 during the three months ended June 30, 2024. This increase resulted primarily due to an increase in compensation expenses of $417,000 due to hiring of new employees in connection with our expansion in the United States and an increase of $16,000 in miscellaneous expenses.
Selling and Marketing Expenses. For the three months ended June 30, 2025, selling and marketing expenses increased by $2,727,000, or 188.7%, to $4,172,000 from $1,445,000 during the three months ended June 30, 2024. This increase resulted primarily from an increase in compensation expenses of $2,317,000 and related travel expenses of $267,000 as the Company continued to build its U.S. commercial infrastructure in connection with FDA approval for CGuard Prime and the commercial launch in the United States and an increase of $143,000 in miscellaneous expenses.
General and Administrative Expenses. For the three months ended June 30, 2025, general and administrative expenses increased by $1,581,000, or 42.2%, to $5,326,000, from $3,745,000 during the three months ended June 30, 2024. The increase was primarily driven by a $1,119,000 increase in compensation expenses and related accruals, mainly due to new hires for our U.S. headquarters, salary increases and expected severance payments accrued as a result of our former chief financial officer’s announced retirement, a $98,000 increase for rent expenses, mainly related to our U.S. headquarters, and an increase of $364,000 in miscellaneous expenses.
| 7 |
Financial Income (Expenses). For the three months ended June 30, 2025, financial income decreased by $483,000 to $132,000 of financial expenses, from $351,000 of financial income during the three months ended June 30, 2024. The decrease in financial income primarily resulted from a $313,000 increase in financial expenses related to changes in exchange rates and a $169,000 decrease in financial income from investment in marketable securities and money market funds.
Tax Expenses. For the three months ended June 30, 2025, there was no material change in our tax expenses as compared to the three months ended June 30, 2024.
Net Loss. Our net loss increased by $5,242,000, or 66.3%, to $13,151,000, for the three months ended June 30, 2025, from $7,909,000 during the three months ended June 30, 2024. The increase in net loss resulted primarily from an increase of $4,741,000 in operating expenses.
Six months ended June 30, 2025, compared to the six months ended June 30, 2024
Revenues. For the six months ended June 30, 2025, revenue increased by $57,000, or 1.8%, to $3,307,000, from $3,250,000 during the six months ended June 30, 2024. The increase was driven by continued adoption of our CGuard technology, as well as positive impact of foreign exchange, offset by a decrease in revenues from Russia due to exchange rates implications and certain European distributors managing CGuard inventory levels in anticipation of the CGuard Prime launch in Europe.
With respect to geographical regions, the increase in revenue was primarily attributable to a $163,000 increase in Latin America, a $60,000 increase in Asia, both due to continued adoption of our CGuard technology, and a $32,000 increase in North America due to sales in the United States related to stents used in our CGUARDIANS II pivotal study. This increase was offset by a $192,000 decrease in Europe driven by the impact of foreign exchange and distributors managing CGuard inventory levels in anticipation of the CGuard Prime launch in Europe, and a $6,000 decrease in other territories.
Gross Profit. For the six months ended June 30, 2025, gross profit (revenue less cost of revenues) decreased by $18,000, or 2.8%, to $605,000, compared to $623,000 for the same period in 2024. Gross margin (gross profit as a percentage of revenue) decreased to 18.3% for the six months ended June 30, 2025, from 19.2% for the six months ended June 30, 2024, driven by the factors mentioned above.
Research and Development Expenses. For the six months ended June 30, 2025, research and development expenses increased by 31.0%, or $1,867,000 to $7,893,000, from $6,026,000 during the six months ended June 30, 2024. This increase resulted primarily due to an increase of $932,000 of SwitchGuard NPS development and regulatory approval process including expenses related to CGUARDIANS II pivotal study of the CGuard Prime 80cm Carotid Stent System, an increase in compensation expenses of $786,000 due to hiring of new employees in connection with our expansion in the United States and due to an increase of share-based compensation-related expenses and an increase of $149,000 in miscellaneous expenses.
Selling and Marketing Expenses. For the six months ended June 30, 2025, selling and marketing expenses increased by 158.1%, or $4,240,000, to $6,922,000, from $2,682,000 during the six months ended June 30, 2024. This increase resulted primarily from an increase in compensation expenses of $3,440,000 and related travel expenses of $396,000 as the Company continued to build its U.S. commercial infrastructure in connection with FDA approval for CGuard Prime and the commercial launch in the United States. In addition, there was an increase of $311,000 in promotional activities and an increase of $93,000 in miscellaneous expenses.
General and Administrative Expenses. For the six months ended June 30, 2025, general and administrative expenses increased by 35.3%, or $2,680,000, to $10,269,000, from $7,589,000 during the six months ended June 30, 2024. The increase was primarily driven by a $1,877,000 increase in compensation expenses and related accruals, mainly due to new hires for our U.S. headquarters, salary increases and expected severance payments accrued as a result of our former chief financial officer’s announced retirement, a $290,000 increase in employee headhunting fees, $196,000 for rent expenses, mainly related to our U.S. headquarters, and an increase of $317,000 in miscellaneous expenses.
| 8 |
Financial Income. For the six months ended June 30, 2025, financial income decreased by $571,000, to $162,000 of financial income, from $733,000 of financial income during the six months ended June 30, 2024. The decrease in financial income primarily resulted from a $280,000 decrease in income from investment in marketable securities and money market funds and a $292,000 increase in financial expenses related to changes in exchange rates
Tax Expenses. For the six months ended June 30, 2025, there was no material change in our tax expenses as compared to the six months ended June 30, 2024.
Net Loss. Our net loss increased by $9,376,000, or 62.8%, to $24,317,000, for the six months ended June 30, 2025, from $14,941,000 during the six months ended June 30, 2024. The increase in net loss resulted primarily from an increase of $8,787,000 in operating expenses and a decrease of $571,000 in financial income.
Liquidity and Capital Resources
We had an accumulated deficit as of June 30, 2025, of $278 million, as well as a net loss of $24.3 million and negative operating cash flows. We expect to continue incurring losses and negative cash flows from operations until our product, CGuard Prime, reaches commercial profitability. As a result of these expected losses and negative cash flows from operations, along with our current cash position, we believe we do not have sufficient resources to fund operations for at least the next 12 months. Therefore, there is substantial doubt about our ability to continue as a going concern.
Our plans include continued commercialization of our products and raising capital through sale of additional equity securities, debt or capital inflows from strategic partnerships and exercise of warrants. There are no assurances, however, that we will be successful in obtaining the level of financing needed for our operations. If we are unsuccessful in commercializing our products or raising capital, we may need to reduce activities, curtail or cease operations.
In May 2023, we closed a private placement offering of 10,266,270 shares of our common stock, pre-funded warrants to purchase up to 15,561,894 shares of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock, consisting of Series H warrants to purchase up to 12,914,086 shares of common stock (the “Series H Warrants”), Series I warrants to purchase up to 12,914,078 shares of common stock (the “Series I Warrants”), Series J warrants to purchase up to 12,914,086 shares of Common Stock (the “Series J Warrants”) and Series K warrants to purchase up to 12,914,086 shares of common stock (the “Series K Warrants” and together with the Series H Warrants, Series I Warrants and Series J Warrants, the “Warrants”), at an offering price of $1.6327 per Private Placement Share and associated Warrants and an offering price of $1.6326 per Pre-Funded Warrant and associated Warrants that resulted in aggregate gross proceeds of approximately $42.2 million, before deducting fees payable to the placement agent and other offering expenses payable by us. If the Warrants issued in the private placement offering are exercised in cash in full this would result in an additional $71.4 million of gross proceeds, of which $35.7 million have been received as of the date of this Quarterly Report on Form 10-Q.
In May 2024, we entered into an Equity Distribution Agreement with Piper Sandler & Co., as sales agent (“Piper Sandler), pursuant to which we may offer and sell, from time to time, at our option, through or to Piper Sandler up to $75,000,000 of our common stock (the “ATM Program”). As of the issuance date of this report, we have sold 920,898 shares of our common stock for total gross proceeds of approximately $2,396 thousands under the ATM Program.
During June 2024, Series H warrants to purchase 12,914,086 shares of common stock that were issued in the May 2023 private placement were exercised in full into 292,996 of shares of common stock and pre-funded warrants to purchase 12,621,090 shares of common stock. The net proceeds to the Company from the exercise of the Series H Warrants were $16.9 million after deducting placement agent fees.
During June and July 2025, Series I warrants to purchase 12,914,078 shares of common stock that were issued in the May 2023 private placement were exercised in full into 2,352,393 of shares of common stock and pre-funded warrants to purchase 10,561,685 shares of common stock. The net proceeds to the Company from the exercise of the Series I Warrants were $16.9 million after deducting placement agent fees.
On August 1 2025, we closed the Private Placement Offering that resulted in aggregate gross proceeds of approximately $40.1 million, before deducting fees payable to the placement agent and other offering expenses payable by the Company.
| 9 |
Six months ended June 30, 2025, compared to the Six months ended June 30, 2024
General. At June 30, 2025, we had cash and cash equivalents of $11,509,000 and marketable securities of $7,865,000, as compared to cash and cash equivalents of $18,916,000 and marketable securities of $15,721,000 as of December 31, 2024. We have historically met our cash needs through a combination of issuing new shares, borrowing activities and product sales. Our cash requirements are generally for research and development, marketing and sales activities, finance and administrative costs, capital expenditures and general working capital.
For the six months ended June 30, 2025, net cash used in our operating activities increased by $7,707,000, or 81.8%, to $17,125,000, from $9,418,000 during the same period in 2024. The primary reason for the increase in cash used in our operating activities was an increase of $1,826,000 in payments for third party related expenses and for professional services, an increase of $5,288,000 in compensation costs paid during the six months ended June 30, 2025 (from $6,186,000 in the six months ended June 30, 2024 to $11,474,000 in the six months ended June 30, 2025), a decrease of $346,000 in payments received from customers during the six months ended June 30, 2025 (from $3,726,000 in the six months ended June 30, 2024 to $3,380,000 during the six months ended June 30, 2025) and a decrease of $247,000 in interest income received from money market funds and marketable securities.
Cash provided by our investing activities was $7,024,000 during the six months ended June 30, 2025, compared to $10,323,000 during the six months ended June 30, 2024. The primary reason for the decrease in cash provided by our investing activities is investment of $3,029,000, net of withdrawal in marketable securities and an increase of $265,000 in payments made for purchase of property, plant and equipment during the six months ended June 30, 2025.
Cash provided by financing activities for the six months ended June 30, 2025, was $2,643,000. The source of the cash provided by financing activities during the six months ended June 30, 2025, were the proceeds from exercise of Series I warrants of $1,947,000, and proceeds from issuance of shares of $696,000, net of issuance costs, received from our ATM Program. Cash provided by financing activities for the six months June 30, 2024, was $17,854,000. The source of the cash provided by financing activities during the six months ended June 30, 2024, were the proceeds from exercise of Series H warrants.
Off Balance Sheet Arrangements
We have no off-balance sheet transactions, arrangements, obligations (including contingent obligations) or other relationships with unconsolidated entities or other persons that have, or may have, a material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.
Factors That May Affect Future Operations
We believe that our future operating results will continue to be subject to quarterly variations based upon a wide variety of factors, including the cyclical nature of the ordering patterns of our distributors, timing of regulatory approvals, the implementation of various phases of our clinical trials and manufacturing efficiencies due to the learning curve of utilizing new materials and equipment. Our operating results could also be impacted by a weakening of the Euro and strengthening of the NIS, both against the U.S. dollar. Lastly, other economic conditions we cannot foresee may affect customer demand, such as individual country reimbursement policies pertaining to our products.
| 10 |
Contractual Obligations and Commitments
During the six months ended June 30, 2025, there were no material changes to our contractual obligations and commitments since the year ended December 31, 2024.
Recently Adopted and Issued Accounting Pronouncements
See Note 3 to our condensed financial statements in Part I, Item 1 of this Quarterly Report on Form 10-Q for new accounting pronouncements adopted.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Not applicable.
Item 4. Controls and Procedures
Management’s Conclusions Regarding Effectiveness of Disclosure Controls and Procedures
As of June 30, 2025, we conducted an evaluation, under the supervision and participation of management including our chief executive officer and chief financial officer, of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) of the Securities Exchange Act of 1934, as amended). There are inherent limitations to the effectiveness of any system of disclosure controls and procedures. Accordingly, even effective disclosure controls and procedures can only provide reasonable assurance of achieving their control objectives.
Based upon this evaluation, our chief executive officer and chief financial officer concluded that our disclosure controls and procedures are effective at the reasonable assurance level as of June 30, 2025.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the fiscal quarter ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
From time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business. There are currently no pending material legal proceedings, and we are currently not aware of any legal proceedings or claims against us or our property that we believe will have any significant effect on our business, financial position or operating results.
Item 1A. Risk Factors
Except as set forth below in this Item 1A and the Risk Factors included in our previous filings made with the SEC, there have been no material changes to our risk factors from those disclosed in “Part I. Item 1A. Risk Factors” in the Form 10-K filed with the SEC on March 12, 2025.
| 11 |
Management has concluded that there is substantial doubt about our ability to continue as a going concern, and our condensed financial statements for the quarter ended June 30, 2025 includes an explanatory paragraph as to our ability to continue as a going concern, which could prevent us from obtaining new financing on reasonable terms or at all.
Because we have had recurring losses and negative cash flows from operating activities, substantial doubt exists regarding our ability to remain as a going concern at the same level at which we are currently performing. Accordingly, our condensed financial statements for the quarter ended June 30, 2025 includes an explanatory paragraph as to our potential inability to continue as a going concern. The doubts regarding our potential ability to continue as a going concern may adversely affect our ability to obtain new financing on reasonable terms or at all.
If there are significant shifts in the political, economic and military conditions in Israel and its neighbors, it could have a material adverse effect on our business relationships and profitability.
Our current manufacturing facility, certain of our key personnel and one of our offices are located in Israel. Our business is directly affected by the political, economic and military conditions in Israel and its neighbors. Since the establishment of the State of Israel in 1948, a number of armed conflicts have occurred between Israel and its Arab neighbors.
In October 2023, Hamas terrorists infiltrated Israel’s southern border from the Gaza Strip and conducted a series of attacks on civilian and military targets. Hamas also launched extensive rocket attacks on Israeli population and industrial centers located along Israel’s border with the Gaza Strip and in other areas within the State of Israel. These attacks resulted in extensive deaths, injuries and kidnapping of civilians and soldiers. Following the attack, Israel’s security cabinet declared war against Hamas and a military campaign against these terrorist organizations commenced in parallel to their continued rocket and terror attacks.
In addition, since the commencement of these events, there have been continued hostilities along Israel’s northern border with Lebanon (with the Hezbollah terror organization) and on other fronts from various extremist groups in region, such as the Houthis in Yemen and various rebel militia groups in Syria and Iraq. In October 2024, Israel began limited ground operations against Hezbollah in Lebanon, and in November 2024, a ceasefire was brokered between Israel and Hezbollah. In addition, in April 2024 and October 2024, Iran launched direct attacks on Israel involving hundreds of drones and missiles and has threatened to continue to attack Israel and is widely believed to be developing nuclear weapons. In June 2025, in light of continued nuclear threats and intelligence assessments indicating imminent attacks, Israel launched a preemptive strike directly targeting military and nuclear infrastructure inside Iran, aimed at disrupting Iran’s capacity to coordinate or launch further hostilities against Israel, as well as to degrade its nuclear program. In response, Iran launched multiple waves of drones and ballistic missiles at Israeli cities. While most of these attacks were intercepted, several caused civilian casualties and damage to infrastructure. The Israeli military has since conducted additional operations against Iranian assets. While a ceasefire was reached between Israel and Iran in June 2025 after 12 days of hostilities, the situation remains volatile. A broader regional conflict involving additional state and non-state actors remains a significant risk. Iran is also believed to have a strong influence among extremist groups in the region, such as Hamas in Gaza, Hezbollah in Lebanon, the Houthi movement in Yemen and various rebel militia groups in Syria and Iraq. These situations may potentially escalate in the future to more violent events which may affect Israel and us. Additionally, Yemeni rebel group, the Houthis, launched series of attacks on global shipping routes in the Red Sea, causing disruptions of supply chain. Such clashes may escalate in the future into a greater regional conflict.
In connection with the Israeli security cabinet’s declaration of war against Hamas and possible hostilities with other organizations, several hundred thousand Israeli military reservists were drafted to perform immediate military service, including five full time employees in Israel of ours. Although many of such military reservists have since been released, including all our employees, they may be called up for additional reserve duty, depending on developments in the war in Gaza and along Israel’s other borders. Military service call ups that result in absences of personnel from us for an extended period of time may materially and adversely affect our business, prospects, financial condition and results of operations. As of the date hereof, we currently have 66 full-time employees located in Israel.
Since the war broke out on October 7, 2023, our operations have not been adversely affected by this situation. However, we currently manufacture our CGuard at our facility in Tel Aviv, Israel. If there were a disruption to our existing manufacturing facility or our ability to procure raw materials and ship our products, we would have no other means of manufacturing and distributing CGuard until we were able to restore the manufacturing and distribution capability at our facility or develop alternative manufacturing facilities and distribution capabilities.
| 12 |
The intensity and duration of Israel’s current war is difficult to predict at this stage, as are such war’s economic implications on the Company’s business and operations and on Israel’s economy in general. If the ceasefires declared collapse or a new war commences or hostilities expand to other fronts, our operations may be adversely affected.
Our commercial insurance does not cover losses that may occur as a result of events associated with war and terrorism. Although the Israeli government currently covers the reinstatement value of direct damages that are caused by terrorist attacks or acts of war, we cannot assure you that this government coverage will be maintained or that it will sufficiently cover our potential damages. Any losses or damages incurred by us could have a material adverse effect on our business. Any armed conflicts or political instability in the region would likely negatively affect business conditions and could harm our results of operations.
The continued political instability and hostilities between Israel and its neighbors and any future armed conflict, terrorist activity or political instability in the region could adversely affect our operations in Israel and adversely affect the market price of our shares of common stock. In addition, several organizations and countries may restrict doing business with Israel and Israeli companies have been and are today subjected to economic boycotts. The interruption or curtailment of trade between Israel and its present trading partners could adversely affect our business, financial condition and results of operations.
Finally, political conditions within Israel may affect our operations. Israel has held five general elections between 2019 and 2022, and prior to October 2023, the Israeli government pursued extensive changes to Israel’s judicial system, which sparked extensive political debate and unrest. Actual or perceived political instability in Israel or any negative changes in the political environment, may individually or in the aggregate adversely affect the Israeli economy and, in turn, our business, financial condition, results of operations and growth prospects.
Changes to trade policy, including tariff and customs regulations, or failure to comply with such regulations may have an adverse effect on our reputation, business, financial condition and results of operations.
Changes in U.S. or international social, political, regulatory and economic conditions or in laws and policies governing trade, manufacturing, development and investment in the countries where we currently conduct our business could adversely affect our business, reputation, financial condition and results of operations. Changes or proposed changes in U.S. or other countries’ trade policies may result in restrictions and economic disincentives on international trade.
We currently manufacture, package and distribute all of our products, including the CGuard Prime carotid stent system, which we commercially launched in July 2025 following FDA approval of the PMA in June 2025, at our own facility in Israel. To support our anticipated production growth following the anticipated commercialization of the CGuard Prime carotid stent system, we have engaged Aptyx Interventional Systems (“Aptyx”), a contract manufacturer that is a developer and manufacturer of complex components and devices for the life sciences, to transfer the manufacturing of CGuard Prime finished goods to full-scale production at their ISO Class 7 cleanroom facility in North Carolina. While we are in the process of establishing manufacturing operations in the United States with Aptyx, this transition will take time, and until it is operational, we expect to rely entirely on product shipments from Israel to the U.S. market.
The U.S. government has recently imposed, or is currently considering imposing, tariffs on certain products, including medical devices, on certain trade partners, including Israel. Tariffs, economic sanctions and other changes in U.S. trade policy have in the past and could in the future trigger retaliatory actions by affected countries, and certain foreign governments have instituted or are considering imposing retaliatory measures on certain U.S. goods. Further, any emerging protectionist or nationalist trends (whether regulatory- or consumer-driven) either in the United States or in other countries could affect the trade environment. Our business, like many other corporations, would be impacted by changes to the trade policies of the United States and foreign countries (including governmental action related to tariffs, international trade agreements, or economic sanctions). If new tariffs are enacted while we remain dependent on Israeli manufacturing, our cost of goods sold for the U.S. market may increase materially, which could negatively impact our gross margins and limit our pricing flexibility. Additionally, changes to trade agreements or customs regulations between the U.S. and Israel could increase lead times, introduce logistical complexities, or require modifications to our supply chain planning. These or similar trade-related developments may have a material adverse effect on our business, financial condition, and results of operations.
| 13 |
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable.
Item 5. Other Information
During
the quarter ended June 30, 2025, no director or officer of the Company
Item 6. Exhibits
EXHIBIT INDEX
| 14 |
* Filed herewith.
| 15 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| INSPIREMD, INC. | ||
| Date: August 4, 2025 | By: | /s/ Marvin Slosman |
| Name: | Marvin Slosman, | |
| Title: | President and Chief Executive Officer (Principal Executive Officer) | |
| Date: August 4, 2025 | By: | /s/ Michael Lawless |
| Name: | Michael Lawless | |
| Title: | Chief Financial Officer (Principal Financial and Accounting Officer) | |
| 16 |