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): August 6, 2024
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 Number) | (IRS<br>Employer<br><br> <br>Identification No.) |
| 4 Menorat Hamaor St.<br><br> <br>Tel Aviv, Israel | 6744832 |
| --- | --- |
| (Address<br> of Principal Executive Offices) | (Zip<br> 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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> communications 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<br> Stock, par value $0.0001 per share | NSPR | The<br> Nasdaq Capital Market 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 August 6, 2024, InspireMD, Inc. issued a press release announcing its financial and operating results and recent highlights for the three and six months ended June 30, 2024. 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 August 6, 2024 (furnished herewith pursuant to Item 2.02) |
| 104 | Cover<br> Page Interactive Data File (embedded within the 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:<br> August 6, 2024 | By: | /s/ Craig Shore |
| Name: | Craig<br> Shore | |
| Title: | Chief<br> Financial Officer |
Exhibit99.1
InspireMDReports Second Quarter 2024 Financial Results and Provides
BusinessUpdate
-Announced positive outcomes from the C-GUARDIANS IDE clinical trial of the CGuard™ Prime carotid stent system demonstrating a one-yearprimary endpoint event rate of 1.95%, the lowest for any carotid stent or embolic protection device pivotal trial –
-On track to submit a Premarket Approval (PMA) application to the FDA this quarter -
-Raised gross proceeds of $17.9 million from full exercise of Series H warrants triggered by announcement of C-GUARDIANS data -
—
Managementto host investor conference call today, August 6^th^, at 8:30am ET
—
TelAviv, Israel and Miami, FL — August 6, 2024 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced financial and operating results for the second quarter ended June 30, 2024.
SecondQuarter 2024 and Recent Developments:
| ● | Announced<br> one-year outcomes from the C-GUARDIANS IDE clinical trial of CGuard™ Prime demonstrating<br> a primary endpoint event rate of 1.95% through one year, the lowest such event<br> rate for any carotid stent or embolic protection device pivotal clinical trial. |
|---|---|
| ● | Announced<br> the full exercise of 12.9 million Series H warrants issued pursuant to the transformational<br> public financing of up to $113.6 million announced in May 2023. The Series H warrants were<br> exercised primarily into pre-funded warrants and resulted in gross proceeds of $17.9 million,<br> or $16.9 million after fees. |
| --- | --- |
| ● | Generated<br> second quarter 2024 CGuard EPS revenue of $1.74 million, an increase of 5.4% over the second<br> quarter of 2023, on 2,969 CGuard stents sold, up nearly 6% over the second quarter of 2023. |
| --- | --- |
| ● | Engaged<br> with a leading MedTech search firm, The Mullings Group, to accelerate build-out of world-class<br> operations and commercial teams in the United States. |
| --- | --- |
| ● | Announced<br> completion of enrollment in groundbreaking CREST-2 clinical trial, with 23 patients in the<br> stenting arm treated with CGuard, the only investigational device allowed by FDA for inclusion<br> in the trial. |
| --- | --- |
| ● | Advanced<br> preparation activities for initiation of the CGUARDIANS II Transcarotid Arterial Revascularization<br> (TCAR) clinical trial in the back half of 2024. |
| --- | --- |
MarvinSlosman, CEO of InspireMD, commented: “The clear highlight since our last quarterly report was the announcement of best in class one-year outcomes data from our pivotal C-GUARDIANS clinical trial of the CGuard Carotid Stent System, which was designed to support a Premarket Approval (PMA) application to FDA later this year. The data demonstrated a primary endpoint event rate of 1.95% through one year, the lowest such rate for any carotid stent or embolic protection device pivotal clinical trial, thus adding to the significant body of data that we have compiled demonstrating the outstanding performance of CGuard both short- and long-term. With these results in hand, we intend to proceed with a PMA application in the back half of this year while continuing to build out a world-class US commercial infrastructure in anticipation of FDA approval in the first half of 2025.
“In parallel, we continued to advance development of our pipeline of carotid intervention and stroke prevention tools, including our SwitchGuard NPS TCAR solution, and we remain on track to initiate our CGUARDIANS II clinical trial in the back half of this year. By uniquely developing solution sets for both CAS and TCAR utilizing our best-in-class CGuard Prime stent implant, we believe we are well positioned for the ongoing paradigm shift toward an endovascular ‘stent first’ approach. I am very pleased with our continued progress and look forward to a productive back half of the year,” Mr. Slosman concluded.
FinancialResults for the Second Quarter ended June 30, 2024
For the three months ended June 30, 2024, revenue increased by $90,000, or 5.4%, to $1,739,000, from $1,649,000 for the three months ended June 30, 2023. This increase was driven by growth in existing and new markets, partially offset by a reduction in clinical trial revenue driven by the conclusion of C-GUARDIANS enrollment in June 2023.
For the three months ended June 30, 2024, gross profit (revenue less cost of revenues) decreased by $160,000, or 32.6%, to $331,000, from $491,000 during the three months ended June 30, 2023. This decrease in gross profit resulted from an increase in material and labor costs mainly due to compensation expense for new and current employees, higher sales volume, additional space to build capacity for anticipated increased volume requirements and additional training expenses offset by an increase in revenues. Gross margin (gross profits as a percentage of revenue) decreased to 19.0% during the three months ended June 30, 2024, from 29.8% during the three months ended June 30, 2023, driven by the factors mentioned above.
Total operating expenses for the second quarter of 2024 were $8,591,000, an increase of $2,785,000, or 48.0%, compared to $5,806,000 for the second quarter of 2023. This increase was primarily due to an increase in compensation and development expenses with the vast majority being non-cash share-based compensation-related expenses.
Net loss for the second quarter of 2024 totaled $7,909,000, or $0.22 per basic and diluted share, compared to a net loss of $5,077,000, or $0.24 per basic and diluted share, for the same period in 2023.
As of June 30, 2024, cash, cash equivalents and marketable securities were $47.2 million compared to $39.0 million as of December 31, 2023. This includes the full exercise of Series H Warrants, raising gross proceeds of $17.9 million, related to the announcement of one-year follow up from the C-GUARDIANS pivotal trial.
FinancialResults for the Six Months ended June 30, 2024
For the six months ended June 30, 2024, revenue increased by $362,000, or 12.5%, to $3,250,000, from $2,888,000 for the six months ended June 30, 2023. This sales increase was due to growth in existing and new markets, partially offset by a reduction in clinical trial revenue due to the completion of C-GUARDIANS enrollment in June 2023.
For the six months ended June 30, 2024, gross profit (revenue less cost of revenues) decreased by 27.9%, or $241,000, to $623,000, compared to $864,000 for the same period in 2023. This decrease in gross profit resulted from an increase in material and labor costs mainly due to compensation expense for new and current employees, higher sales volume, additional space to build capacity for anticipated increased volume requirements and additional training expenses offset by an increase of the revenues.
Total operating expenses for the six months ended June 30, 2024, were $16,297,000, an increase of $5,737,000, or 54.3% compared to $10,560,000 for the six months ended June 30, 2023. This increase was primarily due to an increase in compensation and development expenses with the vast majority being non-cash share-based compensation-related expenses.
Net loss for the six months ended June 30, 2024, totaled $14,941,000, or $0.43 per basic and diluted share, compared to a net loss of $9,333,000, or $0.64 per basic and diluted share, for the six months ended June 30, 2023.
ConferenceCall and Webcast Details
Management will host a conference call at 8:30AM ET today, August 6, to review financial results and provide an update on corporate developments. Following management’s formal remarks, there will be a question-and-answer session.
Tuesday,August 6^th^ at 8:30 a.m. ET
| Domestic: | 1-800-445-7795 |
|---|---|
| International: | 1-785-424-1699 |
| Conference ID: | IMD2Q24 |
| Webcast: | Webcast Link – Click<br> Here |
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 revenue growth. Such statements maybe preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,”“projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,”“potential”, “scheduled” or similar words. Forward-looking statements are 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’scontrol, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or impliedby such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated withour history of recurring losses and negative cash flows from operating activities; significant future commitments and the uncertaintyregarding the adequacy of our liquidity to pursue our complete business objectives; our need to raise additional capital to meet ourbusiness requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of ourproducts; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaqlisting standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products;our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to complywith stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our currentand planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other proceduresand products; intense competition in our industry, with competitors having substantially greater financial, technological, research anddevelopment, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of newcompetitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercializationplans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims;product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and otherthird-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 otherforeign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchangerate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economicinstability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products;and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions andassociated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-lookingstatements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’sAnnual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents freeof charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-lookingstatements as a result of new information, future events or otherwise.
InvestorContacts:
Craig Shore
Chief Financial Officer
InspireMD, Inc.
888-776-6804
craigs@inspiremd.com
Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com
investor-relations@inspiremd.com
CONSOLIDATEDSTATEMENTS OF OPERATIONS^(1)^
(U.S. dollars in thousands, except per share data)
| Three months ended June 30, | Six months ended June 30, | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |||||||||
| Revenues | $ | 1,739 | $ | 1,649 | $ | 3,250 | $ | 2,888 | ||||
| Cost of revenues | 1,408 | 1,158 | 2,627 | 2,024 | ||||||||
| Gross Profit | 331 | 491 | 623 | 864 | ||||||||
| Operating Expenses: | ||||||||||||
| Research and development | 3,401 | 1,993 | 6,026 | 3,836 | ||||||||
| Selling and marketing | 1,445 | 892 | 2,682 | 1,680 | ||||||||
| General and administrative | 3,745 | 2,921 | 7,589 | 5,044 | ||||||||
| Total operating expenses | 8,591 | 5,806 | 16,297 | 10,560 | ||||||||
| Loss from operations | (8,260 | ) | (5,315 | ) | (15,674 | ) | (9,696 | ) | ||||
| Financial income | 351 | 238 | 733 | 363 | ||||||||
| Net Loss | $ | (7,909 | ) | $ | (5,077 | ) | $ | (14,941 | ) | $ | (9,333 | ) |
| Net loss per share – basic and diluted | $ | (0.22 | ) | $ | (0.24 | ) | $ | (0.43 | ) | $ | (0.64 | ) |
| Weighted average number of shares of common stock used in computing net loss per share – basic and diluted | 35,877,926 | 21,074,187 | 35,060,451 | 14,619,622 |
CONSOLIDATED BALANCE SHEETS^(2)^
(U.S. dollars in thousands)
| June 30, 2024 | December 31, 2023 | |||
|---|---|---|---|---|
| ASSETS | ||||
| Current Assets: | ||||
| Cash and cash equivalents | $ | 28,385 | $ | 9,640 |
| Marketable securities | 18,778 | 29,383 | ||
| Accounts receivable: | ||||
| Trade, net | 1,307 | 1,804 | ||
| Other | 450 | 648 | ||
| Prepaid expenses | 717 | 578 | ||
| Inventory | 2,206 | 2,106 | ||
| Total current assets | 51,843 | 44,159 | ||
| Non-current assets: | ||||
| Property, plant and equipment, net | 1,595 | 1,060 | ||
| Operating lease right of use assets | 1,257 | 1,473 | ||
| Funds in respect of employee rights upon retirement | 964 | 951 | ||
| Total non-current assets | 3,816 | 3,484 | ||
| Total assets | $ | 55,659 | $ | 47,643 |
| December 31, 2023 | |||||
|---|---|---|---|---|---|
| LIABILITIES AND EQUITY | |||||
| Current liabilities: | |||||
| Accounts payable and accruals: | |||||
| Trade | 927 | 939 | |||
| Other | 6,038 | 5,081 | |||
| Total current liabilities | 6,965 | 6,020 | |||
| Long-term liabilities: | |||||
| Operating lease liabilities | 786 | 1,038 | |||
| Liability for employees rights upon retirement | 1,145 | 1,084 | |||
| Total long-term liabilities | 1,931 | 2,122 | |||
| Total liabilities | 8,896 | 8,142 | |||
| Equity: | |||||
| Common stock, par value 0.0001 per share; 150,000,000 shares authorized at June 30, 2024 and December 31, 2023; 25,196,479 and 21,841,215 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | 3 | 2 | |||
| Preferred C shares, par value 0.0001 per share; 1,172,000 shares authorized at June 30, 2024 and December 31, 2023; 1,718 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively | * | * | |||
| Additional paid-in capital | 283,202 | 261,000 | |||
| Accumulated deficit | (236,442 | ) | (221,501 | ) | |
| Total equity | 46,763 | 39,501 | |||
| Total liabilities and equity | 55,659 | $ | 47,643 |
All values are in US Dollars.
(1) 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; all 2023 financial information is derived from the Company’s 2023 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.
(2) All June 30, 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. All December 31, 2023 financial information is derived from the Company’s 2023 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2023 filed with the Securities