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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 14, 2024
InspireMD,
Inc.
(Exact
Name of Registrant as Specified in Its Charter)
Delaware
(State
or Other Jurisdiction of Incorporation)
001-35731 |
|
26-2123838 |
(Commission
File Number) |
|
(IRS
Employer
Identification No.) |
4
Menorat Hamaor St.
Tel
Aviv, Israel |
|
6744832 |
(Address
of Principal Executive 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 pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
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
Stock, par value $0.0001 per share |
|
NSPR |
|
The
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. ☐
Item
2.02 Results of Operations and Financial Condition
On
May 14, 2024, InspireMD, Inc. issued a press release announcing its financial and operating results and recent highlights for the first
quarter ended March 31, 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.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
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 14, 2024 |
By: |
/s/
Craig Shore |
|
Name: |
Craig
Shore |
|
Title: |
Chief
Financial Officer |
Exhibit
99.1
InspireMD
Reports First Quarter 2024 Financial Results and Provides
Business
Update
-
Generated first quarter 2024 CGuard EPS revenue of $1.51 million, an increase of 22.0% over the first quarter of 2023 -
-
Announced that an abstract detailing one-year outcomes from the C-GUARDIANS IDE clinical trial of CGuard™ Prime has been accepted
for presentation at LINC 2024, to be held May 28-31 -
-
Named Patrick Geraghty, M.D. and Patrick Muck, M.D. as lead principal investigators for the Company’s CGUARDIANS II clinical trial
for Transcarotid Artery Revascularization (TCAR), as well as Dr. William Gray, as advisor to the company -
--
Management
to host investor conference call today, May 14, at 8:30am ET
--
Tel
Aviv, Israel and Miami, FL — May 14, 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 first quarter ended March 31, 2024.
First
Quarter 2024 and Recent Developments:
|
●
|
Generated
CGuard revenue in the first quarter 2024 of $1.51 million, a 22.0% increase over the first quarter of 2023. |
|
|
|
|
●
|
Sold
2,553 CGuard EPS stent systems in the first quarter of 2024, as compared to 2,033 in the first quarter of 2023, an increase of 25.6%. |
|
|
|
|
●
|
Announced
that an abstract of the one-year outcomes from its C-GUARDIANS IDE clinical trial of the CGuard™ Prime Carotid Stent System
for the treatment of carotid artery stenosis has been accepted for presentation at the Leipzig Interventional Course (LINC) 2024,
which is being held May 28-31, in Leipzig, Germany. |
|
○
|
Presentation
of one-year results follows an earlier abstract of 30-day results from C-GUARDIANS which were presented at the Vascular InterVentional
Advances Annual Meeting (VIVA23) and the VEITH Symposium in November 2023. |
|
|
|
|
○
|
The
30-day results demonstrated that patients with carotid artery stenosis and at high risk for carotid endarterectomy (CEA) had an overall
major adverse event rate (death, stroke or myocardial infarction, or DSMI) of 0.95% from procedure through 30 day follow up when
treated with carotid artery stenting (CAS) using CGuard. |
|
|
|
|
○
|
The
announcement of one-year results from C-GUARDIANS will potentially trigger the first of four $17.9 million financing tranches per
the transformational private placement of up to $113.6 million that the company announced in May 2023. |
|
●
|
Named
Patrick Geraghty, M.D., professor of surgery and radiology, section of vascular surgery at Washington University School of Medicine
in St. Louis, MO, and Patrick Muck, M.D., program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati,
OH, as lead principal investigators for the Company’s CGUARDIANS II clinical trial of its SwitchGuard™ neuroprotection
system for use with CGuard Prime in TCAR procedures. |
|
|
|
|
●
|
Announced
recertification of the Company’s CE Mark under the European Union’s new Medical Device Regulation (MDR) regulatory framework. |
|
|
|
|
●
|
Announced
the appointment of medical technology executive Pete Ligotti as Executive Vice President and General Manager of North America. |
Marvin
Slosman, CEO of InspireMD, commented: “Our first quarter results reflect continued momentum and share gains in our served CE
Mark territories, including total revenue of $1.51 million that increased 22.0% year-over-year. We sold more than 2,500 stents during
the quarter, up 25.6% year-over-year and bringing our real-world experience with the CGuard EPS stent platform to over 50,000 stents
sold to date, a noteworthy milestone for our company.
“At
the same time, we remain acutely focused on advancing our ongoing C-GUARDIANS PMA clinical trial through to completion for U.S. market
approval. Recall that the 30-day results that were presented at last year’s VIVA23 and VEITH Symposium showed that stenting with
CGuard in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%. These are best-in-class
results from any carotid pivotal trial conducted to date and form the foundation of our ‘stent first’ strategy.
“We
were very pleased to have recently announced that an abstract of the one-year results from C-GUARDIANS will be presented at the LINC
conference in Germany later this month. This key milestone will potentially allow us to file a Premarket Approval (PMA) application with
the FDA later this year and give us line-of-sight to potential approval in the first half of 2025.
“I
am very pleased with our progress, including building our core business as well as advancing our clinical trials and new product pipeline,
anticipating and preparing for a launch of our best-in-class carotid platforms in the U.S. in 2025,” Mr. Slosman concluded.
Financial
Results for the First Quarter Ended March 31, 2024
For
the first quarter of 2024, total revenue increased 22.0%, to $1,511,000, from $1,239,000 during the first quarter of 2023. This increase
was predominantly driven by growth in existing markets.
Gross
profit for the first quarter of 2024 decreased by $81,000, or 21.6%, to $292,000, compared to a gross profit of $373,000 for the first
quarter of 2023. This decrease resulted primarily from higher training costs of new hires to
build capacity for anticipated increased volume requirements. Gross margin (gross profit as a percentage
of revenue) decreased to 19.4% during the three months ended March 31, 2024, from 30.1% during the three months ended March 31, 2023.
Total
operating expenses for the first quarter of 2024 were $7,706,000, an increase of $2,952,000, or 62.1% compared to $4,754,000 for the
first quarter of 2023. This increase was primarily due to higher share-based compensation resulting from the recognition of grants made
during the second quarter of 2023 and the first quarter of 2024.
Total
financial income for the first quarter of 2024 was $382,000, an increase of $257,000 or 205.6% compared to $125,000 for the first quarter
of 2023. This increase was primarily due to a $264,000 increase in interest income from investments in marketable securities, money market
funds and short-term bank deposits.
Net
loss for the first quarter of 2024 totaled $7,032,000, or $0.21 per basic and diluted share, compared to a net loss of $4,256,000, or
$0.53 per basic and diluted share, for the same period in 2023.
As
of March 31, 2024, cash, cash equivalents and marketable securities were $34.0 million compared to $39.0 million as of December 31, 2023.
Conference
Call and Webcast Details
Management
will host a conference call at 8:30AM ET today, May 14th, 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,
May 14th at 8:30 a.m. ET
|
Domestic:
|
1-877-407-4018
|
|
International:
|
1-201-689-8471 |
|
Conference
ID: |
13745786 |
|
Call
me™ |
Link
here |
|
Webcast:
|
Webcast
Link – Click Here |
About
InspireMD, 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-looking
Statements
This
press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements
regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. 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 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’s control, and cannot be predicted or quantified and consequently, actual results may differ materially
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, significant future commitments
and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; 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; market acceptance of our products; 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 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 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; product malfunctions; price increases for 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 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; 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
and associated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-looking
statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s
Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free
of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking
statements as a result of new information, future events or otherwise.
Investor
Contacts:
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
CONSOLIDATED
STATEMENTS OF OPERATIONS(1)
(U.S.
dollars in thousands, except per share data)
| |
Three months ended | |
| |
March 31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Revenues | |
$ | 1,511 | | |
$ | 1,239 | |
Cost of revenues | |
| 1,219 | | |
| 866 | |
| |
| | | |
| | |
Gross Profit | |
| 292 | | |
| 373 | |
| |
| | | |
| | |
Operating Expenses: | |
| | | |
| | |
Research and development | |
| 2,625 | | |
| 1,843 | |
Selling and marketing | |
| 1,237 | | |
| 788 | |
General and administrative | |
| 3,844 | | |
| 2,123 | |
| |
| | | |
| | |
Total operating expenses | |
| 7,706 | | |
| 4,754 | |
| |
| | | |
| | |
Loss from operations | |
| (7,414 | ) | |
| (4,381 | ) |
| |
| | | |
| | |
Financial Income, net | |
| 382 | | |
| 125 | |
| |
| | | |
| | |
Net Loss | |
$ | (7,032 | ) | |
$ | (4,256 | ) |
| |
| | | |
| | |
Net loss per share – basic and diluted | |
$ | (0.21 | ) | |
$ | (0.53 | ) |
| |
| | | |
| | |
Weighted average number of shares of common stock used in computing net loss per share – basic and diluted | |
| 34,242,976 | | |
| 8,093,340 | |
CONSOLIDATED
BALANCE SHEETS(2)
(U.S.
dollars in thousands)
| |
March 31, 2024 | | |
December 31, 2023 | |
ASSETS | |
| | | |
| | |
Current Assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 9,389 | | |
$ | 9,640 | |
Marketable securities | |
| 24,561 | | |
| 29,383 | |
Accounts receivable: | |
| | | |
| | |
Trade, net | |
| 1,187 | | |
| 1,804 | |
Other | |
| 483 | | |
| 648 | |
Prepaid expenses | |
| 531 | | |
| 578 | |
Inventory | |
| 2,360 | | |
| 2,106 | |
| |
| | | |
| | |
Total current assets | |
| 38,511 | | |
| 44,159 | |
| |
| | | |
| | |
Non-current assets: | |
| | | |
| | |
Property, plant and equipment, net | |
| 1,186 | | |
| 1,060 | |
Operating lease right of use assets | |
| 1,366 | | |
| 1,473 | |
Funds in respect of employee rights upon retirement | |
| 965 | | |
| 951 | |
| |
| | | |
| | |
Total non-current assets | |
| 3,517 | | |
| 3,484 | |
| |
| | | |
| | |
Total assets | |
$ | 42,028 | | |
$ | 47,643 | |
| |
March 31, 2024 | | |
December 31, 2023 | |
LIABILITIES AND EQUITY | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable and accruals: | |
| | | |
| | |
Trade | |
$ | 659 | | |
$ | 939 | |
Other | |
| 4,218 | | |
| 5,081 | |
Total current liabilities | |
| 4,877 | | |
| 6,020 | |
| |
| | | |
| | |
Long-term liabilities: | |
| | | |
| | |
Operating lease liabilities | |
| 914 | | |
| 1,038 | |
Liability for employees rights upon retirement | |
| 1,150 | | |
| 1,084 | |
Total long-term liabilities | |
| 2,064 | | |
| 2,122 | |
| |
| | | |
| | |
Total liabilities | |
$ | 6,941 | | |
$ | 8,142 | |
| |
| | | |
| | |
Equity: | |
| | | |
| | |
Common stock, par value $0.0001 per share; 150,000,000 shares authorized at March 31, 2024 and December 31, 2023; 23,412,385 and 21,841,215 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | |
| 2 | | |
| 2 | |
Preferred C shares, par value $0.0001 per share; 1,172,000 shares authorized at March 31, 2024 and December 31, 2023; 1,718 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively | |
| * | | |
| * | |
Additional paid-in capital | |
| 263,618 | | |
| 261,000 | |
Accumulated deficit | |
| (228,533 | ) | |
| (221,501 | ) |
| |
| | | |
| | |
Total equity | |
| 35,087 | | |
| 39,501 | |
| |
| | | |
| | |
Total liabilities and equity | |
$ | 42,028 | | |
$ | 47,643 | |
(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 March 31, 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 and Exchange Commission.
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