8-K
InspireMD, Inc. (NSPR)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
8-K
CURRENT
REPORT PURSUANT
TO
SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): May 9, 2025
InspireMD,Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware
(State or Other Jurisdiction of Incorporation)
| 001-35731 | 26-2123838 |
|---|---|
| (Commission<br><br> <br>File<br> Number) | (IRS<br> Employer<br><br> <br>Identification<br> No.) |
| 4 Menorat Hamaor St. Tel Aviv, Israel | 6744832 |
| --- | --- |
| (Address of Principal Executive<br> Offices) | (Zip Code) |
(888)776-6804
(Registrant’s Telephone Number, Including Area Code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications<br> pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant<br> to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications<br> pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications<br> pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value<br> $0.0001 per share | NSPR | The Nasdaq Capital Market<br> LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐
Item2.02 Results of Operations and Financial Condition
On May 9, 2025, InspireMD, Inc. issued a press release announcing its financial and operating results and recent highlights for the first quarter ended March 31, 2025. A copy of this press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K that is furnished pursuant to this Item 2.02 shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description |
|---|---|
| 99.1 | Press release, dated May 9, 2025 (furnished herewith pursuant to Item 2.02) |
| 104 | Cover Page Interactive Data File (embedded within the<br> Inline XBRL document) |
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 hereunto duly authorized.
| **** | INSPIREMD, INC. | |
|---|---|---|
| Date: May 9, 2025 | By: | /s/ Craig Shore |
| Name: | Craig Shore | |
| Title: | Chief Financial Officer |
Exhibit99.1
InspireMDReports First Quarter 2025 Financial Results
—
Managementto host investor conference call today, May 9^th^, at 8:30am ET
—
Miami,FL — May 9, 2025 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Prime carotid stent system for the treatment of carotid artery disease and prevention of stroke, today announced financial and operating results for the first quarter ended March 31, 2025.
BusinessHighlights:
| ● | Continued<br> engagement with the U.S. Food and Drug Administration (FDA) on the Premarket Approval (PMA)<br> application for the CGuard Prime carotid stent system in the U.S. Optimistic for an anticipated<br> approval in the third quarter of 2025 |
|---|---|
| ● | Advanced<br> commercial infrastructure and operational readiness ahead of anticipated U.S. launch |
| --- | --- |
| ● | Continued<br> enrollment with excellent pace in the CGUARDIANS II pivotal study of the CGuard Prime carotid<br> stent system for use during TCAR procedures |
| --- | --- |
MarvinSlosman, CEO of InspireMD, commented: “In the first quarter we continued to drive commercial adoption of our technology in our served markets, while laying a strong operational and strategic foundation for upcoming transformational milestones. With a clear roadmap for commercial expansion and a disciplined focus on execution, we’ve built and trained a world-class commercial team—ready to execute at scale upon potential FDA PMA approval. We’re energized by the momentum and confident in the opportunities on the horizon.”
“We continue to work interactively with the FDA and are optimistic for an anticipated approval of CGuard Prime in the third quarter of 2025. Despite dynamics within the agency and the timing of our audit in February, we are confident the remaining items will be successfully completed. I am excited about the transformative milestones ahead as we work to bring this innovative technology to patients in the U.S. and drive the next chapter of InspireMD’s growth,” Mr. Slosman concluded.
FinancialResults for the First Quarter Ended March 31, 2025
For the first quarter of 2025, total revenue increased by $18,000, or 1.2%, to $1,529,000 from $1,511,000 during the first quarter of 2024. This increase was driven by continued adoption of our CGuard technology in existing markets, offset by the impact of foreign exchange and distributors managing CGuard inventory levels in anticipation of CGuard Prime approval in Europe.
Gross profit for the first quarter of 2025 remained constant at $292,000, compared to the gross profit of the first quarter of 2024.
Total operating expenses for the first quarter of 2025 were $11,752,000, an increase of $4,046,000, or 52.5% compared to $7,706,000 for the first quarter of 2024. This increase was primarily due to higher salaries and share-based compensation tied to U.S. sales force expansion ahead of FDA approval. Additional increases stemmed from CGuard Prime launch preparation, U.S. facility rent, and CFO recruitment fees.
Financial income, net for the first quarter of 2025 was $294,000, a decrease of $88,000 or 23.0% compared to $382,000 for the first quarter of 2024. This decrease was primarily due to less interest income from investments in marketable securities and money market funds.
Net loss for the first quarter of 2025 totaled $11,166,000 or $0.22 per basic and diluted share, compared to a net loss of $7,032,000, or $0.21 per basic and diluted share, for the same period in 2024.
As of March 31, 2025, cash and cash equivalents and marketable securities were $26,086,000 compared to $34,637,000 as of December 31, 2024.
ConferenceCall and Webcast Details
Management will host a conference call at 8:30 am ET today, May 9^th^, to review financial results and provide an update on corporate developments. Following management’s formal remarks, there will be a question-and-answer session.
Friday,May 9^th^ at 8:30 a.m. ET
| Domestic: | 1-800-579-2543 |
|---|---|
| International: | 1-785-424-1789 |
| Conference<br> ID: | IMD1Q25 |
| Webcast: | Webcast<br> Link – Click Here |
https://viavid.webcasts.com/starthere.jsp?ei=1713642&tp_key=1c3c464032
AboutInspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR.
We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.
Forward-lookingStatements
Thispress release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statementsregarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding future events, futurefinancial performance, strategies, expectations, competitive environment and regulation, including potential FDA approval and potentialU.S. commercial launch. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,”“expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,”“believes,” “hopes,” “potential”, “scheduled” or similar words. Forward-looking statementsare not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties,many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differmaterially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation,risks and uncertainties associated with our history of recurring losses and negative cash flows from operating activities; substantialdoubt about our ability to continue as a going concern; significant future commitments and the uncertainty regarding the adequacy ofour liquidity to pursue our complete business objectives; our need to raise additional capital to meet our business requirements in thefuture and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; marketacceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinicaltrial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our abilityto generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protectour intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing qualitystandards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials maynot be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competitionin 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 potentialtechnological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customeror supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increasesfor supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products;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 factthat we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical andcommunications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction;the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorableeconomic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. More detailedinformation about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in theCompany’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K andits Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’sweb site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a resultof new information, future events or otherwise.
InvestorContacts:
Craig Shore
Chief Financial Officer
InspireMD, Inc.
888-776-6804
craigs@inspiremd.com
Webb Campbell
Gilmartin Group LLC
Webb@gilmartinir.com
investor-relations@inspiremd.com
CONDENSEDCONSOLIDATED STATEMENTS OF OPERATIONS^(1)^
(U.S. dollars in thousands, except share and per share data)
| Three months ended | ||||||
|---|---|---|---|---|---|---|
| March 31, | ||||||
| 2025 | 2024 | |||||
| Revenues | $ | 1,529 | $ | 1,511 | ||
| Cost of revenues | 1,237 | 1,219 | ||||
| Gross Profit | 292 | 292 | ||||
| Operating Expenses: | ||||||
| Research and development | 4,059 | 2,625 | ||||
| Selling and marketing | 2,750 | 1,237 | ||||
| General and administrative | 4,943 | 3,844 | ||||
| Total operating expenses | 11,752 | 7,706 | ||||
| Loss from operations | (11,460 | ) | (7,414 | ) | ||
| Financial Income, net | 294 | 382 | ||||
| Net Loss | $ | (11,166 | ) | $ | (7,032 | ) |
| Net loss per share – basic and diluted | $ | (0.22 | ) | $ | (0.21 | ) |
| Weighted average number of shares of common stock used in computing net loss per share – basic and diluted | 49,993,509 | 34,242,976 |
CONDENSEDCONSOLIDATED BALANCE SHEETS(2)
(U.S. dollars in thousands, except share and per share data)
| March 31, | December 31, | |||
|---|---|---|---|---|
| 2025 | 2024 | |||
| ASSETS | ||||
| Current Assets: | ||||
| Cash and cash equivalents | $ | 12,383 | $ | 18,916 |
| Marketable securities | 13,703 | 15,721 | ||
| Accounts receivable: | ||||
| Trade, net | 1,580 | 1,572 | ||
| Other | 763 | 682 | ||
| Prepaid expenses | 893 | 1,060 | ||
| Inventory | 2,822 | 2,570 | ||
| Total current assets | 32,144 | 40,521 | ||
| Non-current assets: | ||||
| Long term deposit | 430 | 426 | ||
| Property, plant and equipment, net | 2,736 | 2,371 | ||
| Operating lease right of use assets | 2,225 | 2,360 | ||
| Funds in respect of employee rights upon retirement | 1,137 | 1,129 | ||
| Total non-current assets | 6,528 | 6,286 | ||
| Total assets | $ | 38,672 | $ | 46,807 |
| December 31, | |||||
|---|---|---|---|---|---|
| 2024 | |||||
| LIABILITIES AND EQUITY | |||||
| Current liabilities: | |||||
| Accounts payable and accruals: | |||||
| Trade | 1,727 | $ | 1,254 | ||
| Other | 5,640 | 6,424 | |||
| Total current liabilities | 7,367 | 7,678 | |||
| Long-term liabilities: | |||||
| Operating lease liabilities net of current maturities | 1,639 | 1,796 | |||
| Liability for employee rights upon retirement and others | 1,321 | 1,247 | |||
| Total long-term liabilities | 2,960 | 3,043 | |||
| Total liabilities | 10,327 | $ | 10,721 | ||
| Equity: | |||||
| Common stock, par value 0.0001 per share; 150,000,000 shares authorized at March 31, 2025 and December 31, 2024; 29,752,661 and 26,611,033 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively | 3 | 3 | |||
| Preferred C shares, par value 0.0001 per share; 1,172,000 shares authorized at March 31, 2025 and December 31, 2024; 1,718 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively | * | * | |||
| Additional paid-in capital | 293,014 | 289,589 | |||
| Accumulated deficit | (264,672 | ) | (253,506 | ) | |
| Total equity | 28,345 | 36,086 | |||
| Total liabilities and equity | 38,672 | $ | 46,807 |
All values are in US Dollars.
(1) All 2025 financial information is derived from the Company’s 2025 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2024 financial information is derived from the Company’s 2024 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.
(2) All March 31, 2025financial information is derived from the Company’s 2025 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. All December 31, 2024 financial information is derived from the Company’s 2024 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2024 filed with the Securities and Exchange Commission.