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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended: June 30, 2024
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: 001-35731
InspireMD,
Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
26-2123838 |
(State
or other jurisdiction of |
|
(I.R.S.
Employer |
incorporation
or organization) |
|
Identification
No.) |
4
Menorat Hamaor St.
Tel
Aviv, Israel 6744832
(Address
of principal executive offices)
(Zip
Code)
(888)
776-6204
(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. Yes ☒ No ☐
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).
Yes ☒ No ☐
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 ☐ |
|
Accelerated
filer ☐ |
Non-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 |
Common
Stock, par value $0.0001 per share |
|
NSPR |
|
Nasdaq
Capital Market |
The
number of shares of the registrant’s common stock, $0.0001 par value, outstanding as of August 5, 2024: 25,706,671
TABLE
OF CONTENTS
Item
1. Financial Statements
INSPIREMD,
INC.
CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
AS
OF AND FOR THE QUARTER ENDED JUNE 30, 2024
TABLE
OF CONTENTS
INSPIREMD,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(U.S.
dollars in thousands)
| |
June 30, | | |
December 31, | |
| |
2024 | | |
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 | |
INSPIREMD,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(U.S.
dollars in thousands other than share and per share data)
| |
June 30, | | |
December 31, | |
| |
2024 | | |
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 | |
| |
| | | |
| | |
COMMITMENTS AND CONTINGENT LIABILITIES | |
| - | | |
| - | |
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 | |
| -* | | |
| -* | |
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 | |
The
accompanying notes are an integral part of the consolidated financial statements.
INSPIREMD,
INC.
(Unaudited)
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S.
dollars in thousands, except per share data)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
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, net: | |
| 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 | |
The
accompanying notes are an integral part of the consolidated financial statements.
INSPIREMD,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(Unaudited)
(U.S.
dollars in thousands, except share data)
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
capital | | |
deficit | | |
equity | |
| |
Common stock
| | |
Series C Convertible Preferred Stock | | |
Additional paid-in | | |
Accumulated | | |
Total | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
capital | | |
deficit | | |
equity | |
| |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
BALANCE AT January 1, 2023 | |
| 8,330,918 | | |
| 1 | | |
| 1,718 | | |
| -* | | |
| 218,977 | | |
| (201,585 | ) | |
| 17,393 | |
Net loss | |
| | | |
| | | |
| - | | |
| | | |
| | | |
| (9,333 | ) | |
| (9,333 | ) |
Issuance of common shares, pre-funded warrants and warrants, net of $4,635 issuance costs | |
| 10,266,270 | | |
| 1 | | |
| | | |
| - | | |
| 37,533 | | |
| - | | |
| 37,534 | |
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 4,270 shares | |
| 2,595,016 | | |
| -* | | |
| | | |
| - | | |
| 1,219 | | |
| - | | |
| 1,219 | |
BALANCE AT June 30, 2023 | |
| 21,192,204 | | |
| 2 | | |
| 1,718 | | |
| -* | | |
| 257,729 | | |
| (210,918 | ) | |
| 46,813 | |
The
accompanying notes are an integral part of the consolidated financial statements.
INSPIREMD,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(Unaudited)
(U.S.
dollars in thousands, except share data)
| |
Common stock | | |
Series C Convertible Preferred Stock | | |
Additional paid-in | | |
Accumulated | | |
Total | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
capital | | |
deficit | | |
equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
BALANCE AT April 1, 2023 | |
| 8,326,648 | | |
| 1 | | |
| 1,718 | | |
| -* | | |
| 219,266 | | |
| (205,841 | ) | |
| 13,426 | |
Net loss | |
| | | |
| | | |
| - | | |
| | | |
| | | |
| (5,077 | ) | |
| (5,077 | ) |
Issuance of common shares, pre-funded warrants and warrants, net of $4,635 issuance costs | |
| 10,266,270 | | |
| 1 | | |
| - | | |
| - | | |
| 37,533 | | |
| - | | |
| 37,534 | |
Issuance of common shares, pre-funded warrants and warrants,
net of issuance costs | |
| 10,266,270 | | |
| 1 | | |
| - | | |
| - | | |
| 37,533 | | |
| - | | |
| 37,534 | |
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award | |
| 2,599,286 | | |
| -* | | |
| - | | |
| - | | |
| 930 | | |
| - | | |
| 930 | |
BALANCE AT June 30, 2023 | |
| 21,192,204 | | |
| 2 | | |
| 1,718 | | |
| -* | | |
| 257,729 | | |
| (210,918 | ) | |
| 46,813 | |
The
accompanying notes are an integral part of the consolidated financial statements.
INSPIREMD,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(Unaudited)
(U.S.
dollars in thousands, except share data)
| |
Common stock | | |
Series C Convertible Preferred Stock | | |
Additional paid-in | | |
Accumulated | | |
Total | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
capital | | |
deficit | | |
equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
BALANCE AT January 1, 2024 | |
| 21,841,215 | | |
| 2 | | |
| 1,718 | | |
| -* | | |
| 261,000 | | |
| (221,501 | ) | |
| 39,501 | |
Net loss | |
| | | |
| | | |
| - | | |
| | | |
| | | |
| (14,941 | ) | |
| (14,941 | ) |
Exercise of pre-funded warrants | |
| 1,528,390 | | |
| -* | | |
| - | | |
| - | | |
| - | | |
| - | | |
| -* | |
Exercise of Warrants Series H to 12,621,090 pre-funded warrants
and 292,996 common stock, net of $1,000
issuance costs | |
| 292,996 | | |
| 1 | | |
| - | | |
| - | | |
| 16,853 | | |
| - | | |
| 16,854 | |
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures of 112,382 shares | |
| 1,533,878 | | |
| -* | | |
| - | | |
| - | | |
| 5,349 | | |
| - | | |
| 5,349 | |
BALANCE AT June 30, 2024 | |
| 25,196,479 | | |
| 3 | | |
| 1,718 | | |
| -* | | |
| 283,202 | | |
| (236,442 | ) | |
| 46,763 | |
The
accompanying notes are an integral part of the consolidated financial statements.
INSPIREMD,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(Unaudited)
(U.S.
dollars in thousands, except share data)
| |
Common stock | | |
Series C Convertible Preferred Stock | | |
Additional paid-in | | |
Accumulated | | |
Total | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
capital | | |
deficit | | |
equity | |
| |
| | |
| | |
| | |
| | |
| | |
| | |
| |
BALANCE AT April 1, 2024 | |
| 23,412,385 | | |
| 2 | | |
| 1,718 | | |
| -* | | |
| 263,618 | | |
| (228,533 | ) | |
| 35,087 | |
Balance | |
| 23,412,385 | | |
| 2 | | |
| 1,718 | | |
| -* | | |
| 263,618 | | |
| (228,533 | ) | |
| 35,087 | |
Net loss | |
| | | |
| | | |
| - | | |
| | | |
| | | |
| (7,909 | ) | |
| (7,909 | ) |
Exercise of pre-funded warrants | |
| 1,528,390 | | |
| -* | | |
| - | | |
| - | | |
| - | | |
| - | | |
| -* | |
Exercise of Warrants Series H to 12,621,090 pre-funded warrants
and 292,996 common stock, net of $1,000
issuance costs | |
| 292,996 | | |
| 1 | | |
| - | | |
| - | | |
| 16,853 | | |
| - | | |
| 16,854 | |
Exercise of Warrants Series H to pre-funded warrants and common
stock, net of issuance costs | |
| 292,996 | | |
| 1 | | |
| - | | |
| - | | |
| 16,853 | | |
| - | | |
| 16,854 | |
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures of 37,292 shares | |
| (37,292 | ) | |
| -* | | |
| - | | |
| - | | |
| 2,731 | | |
| - | | |
| 2,731 | |
Share-based compensation related to stock,
restricted stock, restricted stock units and stock options award, net of forfeitures | |
| (37,292 | ) | |
| -* | | |
| - | | |
| - | | |
| 2,731 | | |
| - | | |
| 2,731 | |
BALANCE AT June 30, 2024 | |
| 25,196,479 | | |
| 3 | | |
| 1,718 | | |
| -* | | |
| 283,202 | | |
| (236,442 | ) | |
| 46,763 | |
Balance | |
| 25,196,479 | | |
| 3 | | |
| 1,718 | | |
| -* | | |
| 283,202 | | |
| (236,442 | ) | |
| 46,763 | |
The
accompanying notes are an integral part of the consolidated financial statements.
INSPIREMD,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(U.S.
dollars in thousands)
| |
2024 | | |
2023 | |
| |
Six months ended June 30 | |
| |
2024 | | |
2023 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | | |
| | |
Net loss | |
$ | (14,941 | ) | |
$ | (9,333 | ) |
Adjustments required to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation | |
| 135 | | |
| 113 | |
Gain from sale of property, plant and equipment | |
| - | | |
| (8 | ) |
Loss on amounts funded in respect of employee rights upon retirement | |
| 34 | | |
| 42 | |
Changes in fair value of marketable securities, net of interest received | |
| (435 | ) | |
| 21 | |
Change in liability for employees’ rights upon retirement | |
| 61 | | |
| 31 | |
Other financial expenses | |
| 14 | | |
| 23 | |
Change in operating right of use asset and leasing liability | |
| (55 | ) | |
| (60 | ) |
Share-based compensation expenses | |
| 5,349 | | |
| 1,219 | |
Decrease in interest receivable on short term deposits | |
| - | | |
| 40 | |
Changes in operating asset and liability items: | |
| | | |
| | |
Decrease (increase) in prepaid expenses | |
| (139 | ) | |
| 599 | |
Decrease (increase) in trade receivables | |
| 497 | | |
| (436 | ) |
Decrease (increase) in other receivables | |
| 198 | | |
| (99 | ) |
Increase in inventory | |
| (100 | ) | |
| (68 | ) |
Increase (decrease) in trade payables | |
| (12 | ) | |
| 109 | |
Decrease in other payables | |
| (24 | ) | |
| (349 | ) |
Net cash used in operating activities | |
| (9,418 | ) | |
| (8,156 | ) |
CASH FLOWS FROM INVESTING ACTIVITIES: | |
| | | |
| | |
Investment in short-term bank deposits | |
| - | | |
| (5,500 | ) |
Purchase of property, plant and equipment | |
| (670 | ) | |
| (70 | ) |
Proceeds from sale of property, plant and equipment | |
| - | | |
| 9 | |
Proceeds from matured marketable securities | |
| 13,000 | | |
| - | |
Withdrawal from short-term bank deposits | |
| - | | |
| 12,000 | |
Amounts funded in respect of employee rights upon retirement | |
| (47 | ) | |
| (43 | ) |
Net cash provided by (used in) investing activities | |
| 10,323 | | |
| (22,442 | ) |
CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
Proceeds from exercise of warrants | |
| 17,854 | | |
| | |
Proceeds from issuance of shares and warrants, net | |
| | | |
| 37,534 | |
Net cash provided by financing activities | |
| 17,854 | | |
| 37,534 | |
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | |
| (14 | ) | |
| (23 | ) |
INCREASE IN CASH AND CASH EQUIVALENTS | |
| 18,745 | | |
| 6,913 | |
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD | |
| 9,640 | | |
| 4,632 | |
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF THE PERIOD | |
$ | 28,385 | | |
$ | 11,545 | |
SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES: | |
| | | |
| | |
Issuance Costs not yet paid | |
| 1,000 | | |
| - | |
The
accompanying notes are an integral part of the consolidated financial statements.
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. |
|
|
|
|
|
The
Company markets its products through distributors in international markets, mainly in Europe. |
|
|
|
|
|
As
of the date of issuance of the condensed consolidated financial statements, the Company has the ability to fund its planned
operations for at least the next 12 months. However, the Company expects to continue incurring losses and negative cash flows from
operations until its product, CGuard™ EPS, reaches commercial profitability. Therefore, in order to fund the Company’s
operations until such time that the Company can generate substantial revenues, the Company may need to raise additional
funds. |
|
|
|
|
b. |
War against Hamas
|
|
|
|
|
|
In
October 2023, Israel was attacked by a terrorist organization and entered a state of war. 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 southern border (with the Houthi movement in Yemen) As of the date of these consolidated financial statements, the
war in Israel is ongoing and continues to evolve. The Company operations, including its production facility, are located in Israel.
Currently, such activities in Israel remain largely unaffected. During the six months ended June 30, 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. |
NOTE
2 - BASIS OF PRESENTATION
The
accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated
financial statements for the year ended December 31, 2023. 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, 2023, as found
in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 5, 2024. The results
of operations for the three and six months ended June 30, 2024, are not necessarily indicative of results that could be expected for
the entire fiscal year.
NOTE
3 - RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS
|
|
Recently
adopted accounting pronouncements
|
|
|
|
|
|
In
August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)
2020-06 “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts
in Entity’s Own Equity (Subtopic 815 – 40).” This guidance simplifies the accounting for certain financial
instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own
equity. This ASU is effective for the Company for fiscal years beginning after December 15, 2023, and interim periods within those
fiscal years. The Company adopted the provisions of this update as of January 1, 2024 with no material impact on its condensed
consolidated financial statements. |
Recently
issued accounting pronouncement, not yet adopted
|
1) |
In
November 2023, the FASB issued ASU 2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures”. This
guidance expands public entities segment disclosures primarily by requiring disclosure of significant segment expenses that are
regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an
amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or
loss and assets. Public entities with a single reportable segment are required to provide the new disclosures and all the
disclosures required under Accounting Standards Codification (“ASC”) 280. The guidance is effective for fiscal years
beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption
permitted. The amendments are required to be applied retrospectively to all prior periods presented in an entity’s financial
statements. The Company is currently evaluating this guidance to determine the impact it may have on its condensed consolidated
financial statements related disclosures. |
|
|
|
|
2) |
In
December 2023, the FASB issued 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 condensed consolidated financial statements 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:
SCHEDULE
OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
As of June 30, 2024 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Assets: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents- | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
$ | 20,340 | | |
$ | 20,340 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Marketable securities- | |
| | | |
| | | |
| | | |
| | |
U.S government bonds | |
$ | 18,778 | | |
$ | - | | |
$ | 18,778 | | |
$ | - | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
As of December 31, 2023 ($ in thousands) | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Assets: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents- | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
$ | 7,094 | | |
$ | 7,094 | | |
$ | - | | |
$ | - | |
Cash equivalents | |
$ | 7,094 | | |
$ | 7,094 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Marketable securities- | |
| | | |
| | | |
| | | |
| | |
U.S government bonds | |
$ | 29,383 | | |
$ | - | | |
$ | 29,383 | | |
$ | - | |
Marketable securities | |
$ | 29,383 | | |
$ | - | | |
$ | 29,383 | | |
$ | - | |
The
Company’s debt securities are classified within 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, 2024, is $18,137 thousand.
The cost of marketable securities as of December 31, 2023 is $28,727
thousand.
NOTE
5 - MARKETABLE SECURITIES
The
following table sets forth the Company’s marketable securities for the indicated periods:
SCHEDULE
OF MARKETABLE SECURITIES
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
($ in thousands) | |
U.S government bonds | |
$ | 18,778 | | |
$ | 29,383 | |
Marketable securities | |
$ | 18,778 | | |
$ | 29,383 | |
The
following table summarizes the fair value of the Company’s marketable securities classified by maturity as of June 30, 2024, and
December 31, 2023:
SCHEDULE
OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY
|
|
June
30, |
|
|
December
31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
($
in thousands) |
|
Amounts
maturing within one year |
|
$ |
18,778 |
|
|
$ |
24,523 |
|
Amounts
maturing after one year through two years |
|
|
- |
|
|
|
4,860 |
|
|
|
$ |
18,778 |
|
|
$ |
29,383 |
|
The
table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the six months period
ended June 30, 2024:
SCHEDULE
OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES
| |
Six months ended June 30, | |
|
Six months ended June 30,
|
|
| |
2024 | |
|
2023 |
|
| |
($ in thousands) |
|
| |
| |
|
|
|
Balance at beginning of the period | |
$ | 29,383 | |
|
|
- |
|
Maturity | |
| (13,000 | ) |
|
|
|
|
Interest received | |
| (122 | ) |
|
|
|
|
Changes in fair value during the period | |
| 557 | |
|
|
(21 |
) |
Balance at end of the period | |
| 18,778 | |
|
|
28,817 |
NOTE
6 - EQUITY:
Exercise
of Series H Warrant
The
Series H Warrants have a term of the earlier of (i) five years from the date of issuance and (ii) 20 trading days following the Company’s
public release of primary and secondary end points related to one year follow up study results from the Company’s C-GUARDIANS pivotal
trial.
Following
the announcement on May 28, 2024 of the one year follow up study results from the Company’s C-GUARDIANS pivotal trial, the
Series H warrants for the purchase of 12,914,086
shares of common stock were exercised in full into 292,996
shares of common stock and pre-funded warrants exercisable into 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 deduction of placement agent fees of $1 million. The Series H warrants, each exercisable at $1.3827
per share of common stock and $1.3826
per pre-funded warrant, were issued as part of the private placement financing that the Company consummated on May 15, 2023.
As
of June 30, 2024, there are 26,347,323 outstanding pre-funded warrants.
As
of June 30, 2024, there were 1,718 shares of Series C Preferred Stock outstanding, convertible into an aggregate of 7,952 shares of the
company’s common stock with a total stated value of $10,997.
As
of June 30, 2024, the Company has outstanding warrants to purchase an aggregate of 40,479,588 shares of common stock as follows:
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK
| |
Number of underlying Common stock | | |
Exercise price | |
Expiration date |
|
Series E Warrants | |
| 198,159 | | |
$ | 27.000 | |
September 24, 2024 |
|
Series F Warrants | |
| 433,878 | | |
$ | 7.4250 | |
June 5, 2025-October 16, 2025 |
|
Series G Warrants | |
| 1,092,344 | | |
$ | 10.230 | |
February 8, 2026 |
|
Series I Warrants | |
| 12,914,078 | | |
$ | 1.3827 | |
-* |
|
Series J Warrants | |
| 12,914,086 | | |
$ | 1.3827 | |
-* |
|
Series K Warrants | |
| 12,914,078 | | |
$ | 1.3827 | |
-* |
|
Underwriter Warrants | |
| 12,965 | | |
$ | 7.4250 | |
September 24, 2024 |
|
Total Warrants | |
| 40,479,588 | | |
| | |
|
|
As
of June 30, 2024, the Company had 155,000,000 authorized shares of capital stock, par value $0.0001 per share, of which 150,000,000 are
shares of common stock and 5,000,000 are shares of “blank check” preferred stock.
During
the six months ended June 30, 2024, the Company granted 1,634,403
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 $5.07 million.
During
the six months ended June 30, 2024, the Company granted 563,499 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 $1.77 million.
During
the six months ended June 30, 2024, the Company granted to employees and directors options to purchase a total of 715,614 shares of the
Company’s common stock. The options have exercise prices ranging from $2.71-$3.14 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 0% and expected term of
5.5-6.5 years; expected volatility ranging from 96.40%-119.38%; and risk-free interest rate ranging from 3.93%-4.10%.
The
fair value of the above options, using the Black-Scholes option-pricing model, was approximately $1.85 million.
On
April 1, 2024, the Company granted to consultants options to purchase a total of 125,000 shares of the Company’s common stock.
The options have an exercise price of $2.37 per share, which was the fair market value of the Company’s common stock on the date
of the grant. 25,000 options are subject to a two-year vesting period (of which 12,500 options are vesting in the first year and 12,500
options are vesting in the second year) and 100,000 options with performance conditions related to clinical activities.
In
calculating the fair value of the above options, the Company used the following assumptions: dividend yield of 0% and expected term of
5.125-6 years; expected volatility ranging from 96.01%-100.76%; and risk-free interest rate ranging from 4.33%-4.34%.
The
fair value of the above options, using the Black-Scholes option-pricing model, was $233,169.
NOTE
7 – RELATED PARTIES TRANSACTIONS
During
the six and three months ended June 30, 2024, 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 amount of $30,000 and $15,000, respectively.
NOTE
8 - NET LOSS PER SHARE:
Basic
and diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of shares of common
stock, pre-funded warrants and fully vested restricted stock units outstanding during the period. The calculation of diluted net loss
per share excludes the effect of potential dilution of share options, warrants, and unvested restricted stocks, unvested restricted stock
units and Series C preferred stock as the effect is anti-dilutive.
For
the purpose of calculating basic net loss per share, the additional shares of common stock that are issuable upon exercise of the pre-funded
warrants have been included since the shares are issuable for a negligible consideration, as determined by the Company according to ASC
260-10-45-13, and have no vesting nor any other contingencies associated with them. For the six and three-month periods ended June 30, 2024,
we had weighted average pre-funded warrants of 15,385,212 and 15,515,802, respectively, which were used in the computations of net loss
per share for the six and three-month periods.
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 excluded from the calculations of diluted loss per share were 48,550,189 and 59,624,929 for the six
and three-month periods ended June 30, 2024 and 2023, respectively. This amount includes 3,744,828
and 2,905,615 of unvested restricted stock included in the number of issued and outstanding shares as of June 30, 2024 and 2023, respectively.
NOTE
9 - 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 or due
to the relatively short-term maturities of such instruments.
|
b. |
As of June 30, 2024, and December 31, 2023, allowance for expected
credit loss was immaterial. |
NOTE
10- INVENTORY:
SCHEDULE
OF INVENTORIES
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
($ in thousands) | |
Finished goods | |
$ | 124 | | |
$ | 210 | |
Work in process | |
| 537 | | |
| 562 | |
Raw materials and supplies | |
| 1,545 | | |
| 1,334 | |
Total
inventory | |
$ | 2,206 | | |
$ | 2,106 | |
NOTE
11 - ACCOUNTS PAYABLE AND ACCRUALS - OTHER:
SCHEDULE
OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
($ in thousands) | |
Employees and employee institutions | |
| 1,656 | | |
| 2,188 | |
Accrued vacation and recreation pay | |
| 384 | | |
| 287 | |
Accrued expenses | |
| 1,149 | | |
| 1,115 | |
Issuance costs not yet paid | |
| 1,000 | | |
| - | |
Clinical trial accrual | |
| 1,128 | | |
| 744 | |
Current Operating lease liabilities | |
| 538 | | |
| 557 | |
Other | |
| 183 | | |
| 190 | |
Accounts Payable and
Accruals - Other | |
| 6,038 | | |
| 5,081 | |
NOTE
12 - DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES:
Revenues
are attributed to geographic areas based on the location of the customers. The following is a summary of revenues:
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
Three
months ended
June 30, |
|
|
Six
months ended
June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
($
in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Germany |
|
$ |
307 |
|
|
$ |
276 |
|
|
$ |
549 |
|
|
$ |
490 |
|
Italy |
|
|
264 |
|
|
|
338 |
|
|
|
558 |
|
|
|
605 |
|
Poland |
|
|
207 |
|
|
|
79 |
|
|
|
359 |
|
|
|
198 |
|
Other* |
|
|
961 |
|
|
|
956 |
|
|
|
1,784 |
|
|
|
1,595 |
|
Revenues |
|
$ |
1,739 |
|
|
$ |
1,649 |
|
|
$ |
3,250 |
|
|
$ |
2,888 |
|
By
principal customers:
SCHEDULE
OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
Three
months ended
June 30, |
|
|
Six
months ended
June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Customer
A |
|
|
18% |
|
|
|
17% |
|
|
|
17% |
|
|
|
17% |
|
Customer
B |
|
|
12% |
|
|
|
5% |
|
|
|
11% |
|
|
|
7% |
|
Customer
C |
|
|
6% |
|
|
|
11% |
|
|
|
9% |
|
|
|
12% |
|
All
substantially tangible long lived assets are located in Israel.
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; |
|
|
|
|
● |
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; |
|
|
|
|
●
|
security,
political and economic instability in the Middle East that could harm our business, including due to the current war between Israel
and Hamas; and |
|
|
|
|
● |
current
or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated
liquidity risk |
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 our proprietary MicroNet™ stent platform for
the treatment of carotid artery disease and other vascular disease. A stent is an expandable “scaffold-like” device, usually
constructed of a metallic material, that is inserted into the lumen of the artery to create patency and revascularization of blood flow.
MicroNet, a micron mesh sleeve, is attached over a stent to provide embolic protection both during and after stenting procedures.
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 regulatory framework. Currently, we are seeking strategic partners for a potential launch of CGuard
EPS in Japan and other Asian countries.
On
September 8, 2020, we received approval from the U.S. Food and Drug Administration (“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 is 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 carotid artery stenting (“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. We anticipate reporting primary endpoint results from the C-GUARDIANS
trial at the end of May 2024 that may support the submission of a premarket approval, or PMA, application in the third quarter of 2024
with a view to potential FDA approval of the CGuard Prime stent system in the first half of 2025.
On
May 28, 2024, we announced positive one-year 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 30-day DSMI and Ipsilateral stroke
between 31 and 365 days rate of 1.95% measured from procedure to 1-year follow-up.
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.
In
October 2023, the Centers for Medicare and Medicaid Service (“CMS”) issued its final National Coverage Determination (“NCD”),
expanding coverage of CAS to include both asymptomatic and standard risk patients, significantly expanding the U.S. CAS addressable market.
Our
mission is to offer a comprehensive set of delivery solutions (TCAR and Transfemoral) in order to deliver best in class results through
patient outcomes by way of stent performance with CGuard Carotid Stent System and SwitchGuard NPS.
We
were organized in the State of Delaware on February 29, 2008.
Recent
Developments
One
Year Results from the U.S. Investigational Device Exemption (IDE) clinical trial
On
May 28, 2024, we announced positive one-year follow up results from the C-GUARDIANS trial of the CGuard™ Carotid Stent Systemin
which stenting with the CGuard Carotid Stent System in patients with carotid artery stenosis and at high risk for carotid endarterectomy
had a 30-day DSMI and Ipsilateral stroke between 31 and 365 days rate of 1.95%, measured from procedure to 1-year follow-up.
Exercise
of Series H Warrant
Following
the announcement of the one year follow up study results from the Company’s C-GUARDIANS trial, Series H warrants to purchase 12,914,086
shares of common stock 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. The Series H 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.
Israel-Hamas
War
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 southern border (with the Houthi movement in Yemen). It is possible that hostilities with Hezbollah in Lebanon will escalate, and
that other terrorist organizations, including Palestinian military organizations in the West Bank as well as other hostile countries
will join the hostilities. In addition, Iran recently launched a direct attack 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. 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. Such clashes may escalate in the future into a greater regional conflict. We cannot currently
predict the intensity or duration of Israel’s war against Hamas, nor can we predict how this war will ultimately affect our business
and operations or Israel’s economy in general.
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, 2023. There have not been any material changes
to such critical accounting policies since December 31, 2023.
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, 2024, compared to the three months ended June 30, 2023
Revenues.
For the three months ended June 30, 2024, revenue increased by $90,000, or 5.4%, to $1,739,000, from $1,649,000 during the three months
ended June 30, 2023. This increase was predominantly 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.
With
respect to geographical regions, the increase in revenue was primarily attributable to a $303,000 increase in Europe for reasons mentioned
in the paragraph above. This increase was offset by a $87,000 decrease in Latin America a $80,000 decrease in Asia due to timing of shipment
of orders, and a $45,000 decrease in the United States as we completed in June 2023 the enrollment of all patients in our C-Guardians
IDE clinical trial.
Gross
Profit. 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 a $237,000 increase
in material and labor costs mainly due to higher sales volume as well as compensation expense for new and current employees, additional
space to build capacity for anticipated increased volume requirements and additional training expenses offset by an increase of the revenues
of $90,000 (see above), and an increase $13,000 in miscellaneous expense. 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.
Research
and Development Expenses. For the three months ended June 30, 2024, research and development expenses increased by $1,408,000, or
70.6%, to $3,401,000, from $1,993,000 during the three months ended June 30, 2023. This increase resulted primarily from an increase
in compensation expenses of $741,000, mainly due to an increase of share-based compensation-related expenses due to the expense recognition
of grants made to employees and consultants since the second quarter of 2023 and due to the hiring of the Executive Vice President and
General Manager of North America in connection with our expansion plans in the United States, an increase of $427,000 of SwitchGuard
NPS development and regulatory approval process, an increase of $82,000 related to the establishment of operations in the United States,
an increase of $77,000 related to an early feasibility study of CGuard Prime for the treatment of acute stroke patients with tandem lesions
and an increase of $81,000 in miscellaneous expenses.
Selling
and Marketing Expenses. For the three months ended June 30, 2024, selling and marketing expenses increased by $553,000, or 62.0%,
to $1,445,000, from $892,000 during the three months ended June 30, 2023. This increase resulted primarily from an increase in compensation
expenses of $469,000 and an increase of $84,000 in miscellaneous expenses.
General
and Administrative Expenses. For the three months ended June 30, 2024, general and administrative expenses increased by $824,000,
or 28.2%, to $3,745,000, from $2,921,000 during the three months ended June 30, 2023. This increase resulted primarily from an increase
in compensation expenses of $993,000, mainly due to an increase of share-based compensation-related expenses due to the expense recognition
of grants made during the second quarter of 2023 and the first quarter of 2024, offset by a decrease of $92,000 in legal expenses and
a $77,000 in miscellaneous expenses.
Financial
Income. For the three months ended June 30, 2024, financial income increased by $113,000 or 47.5%, to $351,000, from $238,000 during
the three months ended June 30, 2023. The increase in financial income primarily resulted from a $123,000 increase in interest income
from investment in marketable securities, money market funds and short-term bank deposits.
Tax
Expenses. For the three months ended June 30, 2024, there was no material change in our tax expenses as compared to the three months
ended June 30, 2023.
Net
Loss. Our net loss increased by $2,832,000, or 55.8%, to $7,909,000, for the three months ended June 30, 2024, from $5,077,000 during
the three months ended June 30, 2023. The increase in net loss resulted primarily from an increase of $2,785,000 in operating expenses.
Six
months ended June 30, 2024, compared to the six months ended June 30, 2023
Revenues.
For the six months ended June 30, 2024, revenue increased by $362,000, or 12.5%, to $3,250,000, from $2,888,000 during the six months
ended June 30, 2023. This sales increase was mainly due to 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.
With
respect to geographical regions, the increase in revenue was primarily attributable to a $472,000 increase in Europe, a $28,000 increase
in Latin America and a $8,000 increase in other territories for reasons mentioned above. This increase was offset by a $104,000 decrease
in the United States as we completed in June 2023 the enrollment of all patients in our C-Guardians IDE clinical trial, a $30,000 decrease
in Asia and a $12,000 decrease in other territories.
Gross
Profit. 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 a $864,000 for the same period in 2023. This decrease in gross profit resulted from a $585,000 increase in material
and labor costs mainly due to higher sales volume as well as compensation expense for new and current employees, additional space to
build capacity for anticipated increased volume requirements and additional training expenses offset by an increase of the revenues of
$362,000 (see above), and an increase $18,000 in miscellaneous expense. Gross margin (gross profits as a percentage of revenue) decreased
to 19.2% during the three months ended June 30, 2024, from 29.9% during the three months ended June 30, 2023, driven by the factors mentioned
above.
Research
and Development Expenses. Research and Development Expenses. For the six months ended June 30, 2024, research and development
expenses increased by 57.1%, or $2,190,000 to $6,026,000, from $3,836,000 during the six months ended June 30, 2023. This increase resulted
primarily from an increase in compensation expenses of $1,364,000, mainly due to an increase of share-based compensation-related expenses
due to the expense recognition of grants made to employees and consultants since the second quarter of 2023 and due to the hiring of
the Executive Vice President and General Manager of North America in connection with our expansion plans in the United States, an increase
of $501,000 of SwitchGuard NPS development and regulatory approval process, an increase of $235,000 related to an early feasibility study
of CGuard Prime for the treatment of acute stroke patients with tandem lesions, an increase of $99,000 related to the establishment of
operations in the United States, offset by a decrease of $9,000 in miscellaneous expenses.
Selling
and Marketing Expenses. For the six months ended June 30, 2024, selling and marketing expenses increased by 59.6%, or $1,002,000,
to $2,682,000, from $1,680,000 during the six months ended June 30, 2023. This increase resulted primarily from an increase in compensation
expenses of $850,000 and an increase of $152,000 in miscellaneous expenses.
General
and Administrative Expenses. For the six months ended June 30, 2024, general and administrative expenses increased by 50.5%, or $2,545,000,
to $7,589,000, from $5,044,000 during the six months ended June 30, 2023. This increase resulted primarily from an increase in compensation
expenses of $2,674,000, mainly due to an increase of share-based compensation-related expenses due to the expense recognition of grants
made during the second quarter of 2023 and the first quarter of 2024, offset by a decrease of $129,000 in miscellaneous expenses.
Financial
Income. For the six months ended June 30, 2024, financial income increased by $370,000, to $733,000 of financial income, from $363,000
of financial income during the six months ended June 30, 2023. The increase in financial income primarily resulted from a $387,000 increase
in interest income from investment in marketable securities, money market funds and short-term bank deposits.
Tax
Expenses. For the six months ended June 30, 2024, there was no material change in our tax expenses as compared to the six months
ended June 30, 2023.
Net
Loss. Our net loss increased by $5,608,000, or 60.1%, to $14,941,000, for the six months ended June 30, 2024, from $9,333,000 during
the six months ended June 30, 2023. The increase in net loss resulted primarily from an increase of $5,737,000 in operating expenses
and decrease of $241,000 in gross profit, offset by an increase of $370,000 in financial income.
Liquidity
and Capital Resources
As
of June 30, 2024, we have the ability to fund our planned operations for at least the next 12 months from issuance date of the financial
statement. However, we expect to continue incurring losses and negative cash flows from operations until our products (primarily CGuard™
EPS) reach commercial profitability. Therefore, in order to fund our operations until such time that we can generate substantial revenues,
we may need to raise additional funds.
Our
plans include continued commercialization of our products and raising capital through sale of additional equity securities, debt or capital
inflows from strategic partnerships. 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 (the “Private Placement Shares”) of our common stock,
pre-funded warrants (the “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.
During
June 2024, Series H warrants to purchase 12,914,086 shares of common stock 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.
Six
months ended June 30, 2024 compared to the Six months ended June 30, 2023
General.
At June 30, 2024, we had cash and cash equivalents of $28,385,000 and marketable securities of $18,778,000 as compared to cash and cash
equivalents of $9,640,000 and marketable securities of $29,383,000 as of December 31, 2023. 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, 2024, net cash used in our operating activities increased by $1,262,000, or 15.5%, to $9,418,000, from
$8,156,000 during the same period in 2023. The primary reason for the increase in cash used in our operating activities was an increase
of $1,757,000 in payments for third party related expenses and for professional services, an increase of $874,000 in compensation costs
paid during the six months ended June 30, 2024, from $5,312,000 in the six months ended June 30, 2023 to $6,186,000, offset in part by
an increase of $1,254,000 in payments received from customers, and an increase of $115,000 in interest income received from money market
funds and marketable securities.
Cash
provided in our investing activities was $10,323,000 during the Six months ended June 30, 2024, compared to cash used of $22,442,000
during the Six months ended June 30, 2023. The primary reason for the increase in cash provided by our investing activities is proceeds
from matured marketable securities of $11,040,000, net of investment in marketable securities in the Six months ended June 30, 2024,
compared to an investment in marketable securities of $28,838,000, offset by a withdrawal from short-term bank deposits, net of investment
in short-term deposits, of $6,500,000 in the Six months ended June 30, 2023 and by an increase of $600,000 in payments made for purchase
of property, plant and equipment during the Six months ended June 30, 2024.
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. Cash provided by financing activities
for the six months June 30, 2023, was $37,534,000. The source of the cash provided by financing activities during the six months ended
June 30, 2023, were the proceeds from the Private Placement Offering in May 2023 that resulted in approximately $37,534,000 of aggregate
net proceeds.
As
of June 30, 2024, our current assets exceeded our current liabilities by a multiple of 7.4. Current assets increased by $7,684,000 during
the period and current liabilities increased by $945,000 during the period. As a result, our working capital increased by $6,739,000
to $44,878,000 as of June 30, 2024.
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.
Contractual
Obligations and Commitments
During
the six months ended June 30, 2024, there were no material changes to our contractual obligations and commitments since the year ended
December 31, 2023.
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, 2024, 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, 2024.
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, 2024, 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 5, 2024.
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
executive office, sole manufacturing facility and certain of our key personnel 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 southern border (with the Houthi movement in Yemen, as described below). It is possible that hostilities with Hezbollah in Lebanon
will escalate, and that other terrorist organizations, including Palestinian military organizations in the West Bank as well as other
hostile countries will join the hostilities. In addition, Iran recently launched a direct attack 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. 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 the majority of 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. As
of the date hereof, two of our non-management employees in Israel. 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 56 full-time employees located in Israel and 12 employees located outside of Israel.
Since
the war broke out on October 7, 2023, our operations have not been adversely affected by this situation, and we have not experienced
disruptions to our clinical studies. None of the clinical sites currently participating in our clinical studies are located in Israel
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.
The
intensity and duration of Israel’s current war against Hamas 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 war extends for a long period
of time or expands to other fronts, such as Lebanon, Syria and the West Bank, 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. To date, these initiatives have been substantially put on hold. 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.
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, 2024, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement”
or a “non-Rule 10b5-1 trading arrangement” (in each case, as defined in Item 408 of Regulation S-K).
Item
6. Exhibits
EXHIBIT
INDEX
Exhibit
No. |
|
Description |
|
|
|
3.1 |
|
Amended and Restated Certificate of Incorporation, as amended through March 31, 2015 (incorporated by reference to Exhibit 3.1 to Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2015) |
|
|
|
3.2 |
|
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to Current Report on Form 8-K filed with the Securities and Exchange Commission on June 29, 2021) |
|
|
|
3.3 |
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on May 25, 2016) |
|
|
|
3.4 |
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on September 29, 2016) |
|
|
|
3.5 |
|
Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on March 15, 2017) |
|
|
|
3.6 |
|
Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series C Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on November 29, 2017) |
|
|
|
3.7 |
|
Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on December 12, 2017) |
|
|
|
3.8 |
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on February 7, 2018) |
|
|
|
3.9 |
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on March 28, 2019) |
|
|
|
3.10 |
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc., dated April 14, 2021 (incorporated by reference to Exhibit 3.17 to the Quarterly Report on Form 10-Q filed on May 10, 2021) |
|
|
|
3.11 |
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on September 13, 2023) |
|
|
|
31.1* |
|
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
31.2* |
|
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
32.1* |
|
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
32.2* |
|
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
101.INS* |
|
Inline
XBRL Instance Document (the Instance Document does not appear in the interactive data file because its XBRL tags are embedded within
the Inline XBRL document) |
|
|
|
101.SCH* |
|
Inline
XBRL Taxonomy Extension Schema Document |
|
|
|
101.CAL* |
|
Inline
XBRL Taxonomy Extension Calculation Linkbase Document |
|
|
|
101.DEF* |
|
Inline
XBRL Taxonomy Extension Definition Linkbase Document |
|
|
|
101.LAB* |
|
Inline
XBRL Taxonomy Extension Labels Linkbase Document |
|
|
|
101.PRE* |
|
Inline
XBRL Taxonomy Extension Presentation Linkbase Document |
|
|
|
104* |
|
Cover
Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101) |
*
Filed herewith.
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 5, 2024 |
By: |
/s/
Marvin Slosman |
|
Name:
|
Marvin
Slosman, |
|
Title:
|
President
and Chief Executive Officer
(Principal
Executive Officer) |
|
|
|
Date:
August 5, 2024 |
By: |
/s/
Craig Shore |
|
Name:
|
Craig
Shore |
|
Title: |
Chief
Financial Officer, Secretary and Treasurer
(Principal
Financial and Accounting Officer) |
EXHIBIT
31.1
CERTIFICATION
I,
Marvin Slosman, certify that:
|
1. |
I
have reviewed this Quarterly Report on Form 10-Q of InspireMD, Inc.; |
|
|
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
|
|
4. |
The
registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a. |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d. |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
|
5. |
The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent functions): |
|
a. |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b. |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
August 5, 2024 |
/s/
Marvin Slosman |
|
Marvin
Slosman |
|
Chief
Executive Officer
(Principal
Executive Officer) |
EXHIBIT
31.2
CERTIFICATION
I,
Craig Shore, certify that:
|
1. |
I
have reviewed this Quarterly Report on Form 10-Q of InspireMD, Inc.; |
|
|
|
|
2. |
Based
on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary
to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to
the period covered by this report; |
|
|
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
|
|
4. |
The
registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a. |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
Designed
such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d. |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
|
5. |
The
registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over
financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or
persons performing the equivalent functions): |
|
a. |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b. |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
Date:
August 5, 2024 |
/s/
Craig Shore |
|
Craig
Shore |
|
Chief
Financial Officer, Secretary and Treasurer
(Principal
Financial and Accounting Officer) |
Exhibit
32.1
CERTIFICATION
PURSUANT
TO
18
U.S.C. SECTION 1350
In
connection with the Quarterly Report on Form 10-Q of InspireMD, Inc. (the “Company”) for the period ended June 30, 2024 as
filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Marvin Slosman, Chief Executive Officer
of the Company, certify, pursuant to 18 U.S.C. ss. 1350, that, to my knowledge:
(1) |
The
Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and |
|
|
(2)
|
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company as of and for the periods covered in this report. |
Date:
August 5, 2024 |
By: |
/s/
Marvin Slosman |
|
Name:
|
Marvin
Slosman |
|
Title: |
Chief
Executive Officer
(Principal
Executive Officer) |
Exhibit
32.2
CERTIFICATION
PURSUANT
TO
18
U.S.C. SECTION 1350
In
connection with the Quarterly Report on Form 10-Q of InspireMD, Inc. (the “Company”) for the period ended June 30, 2024 as
filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Craig Shore, Chief Financial Officer
of the Company, certify, pursuant to 18 U.S.C. ss. 1350, that, to my knowledge:
(1) |
The
Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and |
|
|
(2) |
The
information contained in the Report fairly presents, in all material respects, the financial condition and results of operations
of the Company as of and for the periods covered in this report. |
Date:
August 5, 2024 |
By: |
/s/
Craig Shore |
|
Name:
|
Craig
Shore |
|
Title: |
Chief
Financial Officer, Secretary and Treasurer
(Principal
Financial and Accounting Officer) |
v3.24.2.u1
Cover - $ / shares
|
6 Months Ended |
|
Jun. 30, 2024 |
Aug. 05, 2024 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Jun. 30, 2024
|
|
Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-35731
|
|
Entity Registrant Name |
InspireMD,
Inc.
|
|
Entity Central Index Key |
0001433607
|
|
Entity Tax Identification Number |
26-2123838
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
4
Menorat Hamaor St.
|
|
Entity Address, City or Town |
Tel
Aviv
|
|
Entity Address, Country |
IL
|
|
Entity Address, Postal Zip Code |
6744832
|
|
City Area Code |
(888)
|
|
Local Phone Number |
776-6204
|
|
Title of 12(b) Security |
Common
Stock, par value $0.0001 per share
|
|
Trading Symbol |
NSPR
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
false
|
|
Entity Shell Company |
false
|
|
Entity Common Stock, Shares Outstanding |
|
25,706,671
|
Entity Listing, Par Value Per Share |
$ 0.0001
|
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
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
|
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
|
COMMITMENTS AND CONTINGENT LIABILITIES |
|
|
|
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 |
[1] |
|
|
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
|
|
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
150,000,000
|
150,000,000
|
Common stock, shares issued |
25,196,479
|
21,841,215
|
Common stock, shares outstanding |
25,196,479
|
21,841,215
|
Series C Preferred Stock [Member] |
|
|
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
1,172,000
|
1,172,000
|
Preferred stock, shares issued |
1,718
|
1,718
|
Preferred stock, shares outstanding |
1,718
|
1,718
|
X |
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v3.24.2.u1
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
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, net: |
351
|
238
|
733
|
363
|
NET LOSS |
$ (7,909)
|
$ (5,077)
|
$ (14,941)
|
$ (9,333)
|
NET LOSS PER SHARE - basic |
$ (0.22)
|
$ (0.24)
|
$ (0.43)
|
$ (0.64)
|
NET LOSS PER SHARE - diluted |
$ (0.22)
|
$ (0.24)
|
$ (0.43)
|
$ (0.64)
|
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - basic |
35,877,926
|
21,074,187
|
35,060,451
|
14,619,622
|
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - diluted |
35,877,926
|
21,074,187
|
35,060,451
|
14,619,622
|
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v3.24.2.u1
Condensed Consolidated Statements of Changes in Equity (Unaudited) - USD ($) $ in Thousands |
Common Stock [Member] |
Preferred Stock [Member]
Series C Convertible Preferred Stock [Member]
|
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2022 |
$ 1
|
|
|
[1] |
$ 218,977
|
$ (201,585)
|
$ 17,393
|
|
Balance, shares at Dec. 31, 2022 |
8,330,918
|
|
1,718
|
|
|
|
|
|
Net loss |
|
|
|
|
|
(9,333)
|
(9,333)
|
|
Issuance of common shares, pre-funded warrants and warrants, net of issuance costs |
$ 1
|
|
|
|
37,533
|
|
37,534
|
|
Issuance of common shares, pre-funded warrants and warrants, net of issuance costs, shares |
10,266,270
|
|
|
|
|
|
|
|
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures |
|
[1] |
|
|
1,219
|
|
1,219
|
|
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures, shares |
2,595,016
|
|
|
|
|
|
|
|
Balance at Jun. 30, 2023 |
$ 2
|
|
|
[1] |
257,729
|
(210,918)
|
46,813
|
|
Balance, shares at Jun. 30, 2023 |
21,192,204
|
|
1,718
|
|
|
|
|
|
Balance at Mar. 31, 2023 |
$ 1
|
|
|
[2] |
219,266
|
(205,841)
|
13,426
|
|
Balance, shares at Mar. 31, 2023 |
8,326,648
|
|
1,718
|
|
|
|
|
|
Net loss |
|
|
|
|
|
(5,077)
|
(5,077)
|
|
Issuance of common shares, pre-funded warrants and warrants, net of issuance costs |
$ 1
|
|
|
|
37,533
|
|
37,534
|
|
Issuance of common shares, pre-funded warrants and warrants, net of issuance costs, shares |
10,266,270
|
|
|
|
|
|
|
|
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures |
|
[2] |
|
|
930
|
|
930
|
|
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures, shares |
2,599,286
|
|
|
|
|
|
|
|
Balance at Jun. 30, 2023 |
$ 2
|
|
|
[1] |
257,729
|
(210,918)
|
46,813
|
|
Balance, shares at Jun. 30, 2023 |
21,192,204
|
|
1,718
|
|
|
|
|
|
Balance at Dec. 31, 2023 |
$ 2
|
|
|
[3] |
261,000
|
(221,501)
|
39,501
|
|
Balance, shares at Dec. 31, 2023 |
21,841,215
|
|
1,718
|
|
|
|
|
|
Net loss |
|
|
|
|
|
(14,941)
|
(14,941)
|
|
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures |
|
[3] |
|
|
5,349
|
|
5,349
|
|
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures, shares |
1,533,878
|
|
|
|
|
|
|
|
Exercise of pre-funded warrants |
|
[3] |
|
|
|
|
|
[3] |
Exercise of pre-funded warrants, shares |
1,528,390
|
|
|
|
|
|
|
|
Exercise of Warrants Series H to pre-funded warrants and common stock, net of issuance costs |
$ 1
|
|
|
|
16,853
|
|
16,854
|
|
Exercise of Warrants Series H to pre-funded warrants and common stock, net of issuance costs, shares |
292,996
|
|
|
|
|
|
|
|
Balance at Jun. 30, 2024 |
$ 3
|
|
|
[3] |
283,202
|
(236,442)
|
46,763
|
|
Balance, shares at Jun. 30, 2024 |
25,196,479
|
|
1,718
|
|
|
|
|
|
Balance at Mar. 31, 2024 |
$ 2
|
|
|
[4] |
263,618
|
(228,533)
|
35,087
|
|
Balance, shares at Mar. 31, 2024 |
23,412,385
|
|
1,718
|
|
|
|
|
|
Net loss |
|
|
|
|
|
(7,909)
|
(7,909)
|
|
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures |
|
[4] |
|
|
2,731
|
|
2,731
|
|
Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures, shares |
(37,292)
|
|
|
|
|
|
|
|
Exercise of pre-funded warrants |
|
[4] |
|
|
|
|
|
[4] |
Exercise of pre-funded warrants, shares |
1,528,390
|
|
|
|
|
|
|
|
Exercise of Warrants Series H to pre-funded warrants and common stock, net of issuance costs |
$ 1
|
|
|
|
16,853
|
|
16,854
|
|
Exercise of Warrants Series H to pre-funded warrants and common stock, net of issuance costs, shares |
292,996
|
|
|
|
|
|
|
|
Balance at Jun. 30, 2024 |
$ 3
|
|
|
[3] |
$ 283,202
|
$ (236,442)
|
$ 46,763
|
|
Balance, shares at Jun. 30, 2024 |
25,196,479
|
|
1,718
|
|
|
|
|
|
|
|
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v3.24.2.u1
Condensed Consolidated Statements of Changes in Equity (Unaudited) (Parenthetical) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Payments of stock issuance costs |
|
$ 4,635
|
|
$ 4,635
|
Shares, restricted stock award, forfeited |
37,292
|
|
112,382
|
4,270
|
Number of pre-funded warrants issued |
12,621,090
|
|
12,621,090
|
|
Proceeds from issuance of common stock |
$ 1,000
|
|
$ 1,000
|
|
Common Stock [Member] |
|
|
|
|
Common stock shares issued |
292,996
|
|
292,996
|
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v3.24.2.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
Net loss |
$ (14,941)
|
$ (9,333)
|
Adjustments required to reconcile net loss to net cash used in operating activities: |
|
|
Depreciation |
135
|
113
|
Gain from sale of property, plant and equipment |
|
(8)
|
Loss on amounts funded in respect of employee rights upon retirement |
34
|
42
|
Changes in fair value of marketable securities, net of interest received |
(435)
|
21
|
Change in liability for employees’ rights upon retirement |
61
|
31
|
Other financial expenses |
14
|
23
|
Change in operating right of use asset and leasing liability |
(55)
|
(60)
|
Share-based compensation expenses |
5,349
|
1,219
|
Decrease in interest receivable on short term deposits |
|
40
|
Changes in operating asset and liability items: |
|
|
Decrease (increase) in prepaid expenses |
(139)
|
599
|
Decrease (increase) in trade receivables |
497
|
(436)
|
Decrease (increase) in other receivables |
198
|
(99)
|
Increase in inventory |
(100)
|
(68)
|
Increase (decrease) in trade payables |
(12)
|
109
|
Decrease in other payables |
(24)
|
(349)
|
Net cash used in operating activities |
(9,418)
|
(8,156)
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
Investment in short-term bank deposits |
|
(5,500)
|
Purchase of property, plant and equipment |
(670)
|
(70)
|
Proceeds from sale of property, plant and equipment |
|
9
|
Investments in marketable securities |
(1,960)
|
(28,838)
|
Proceeds from matured marketable securities |
13,000
|
|
Withdrawal from short-term bank deposits |
|
12,000
|
Amounts funded in respect of employee rights upon retirement |
(47)
|
(43)
|
Net cash provided by (used in) investing activities |
10,323
|
(22,442)
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
Proceeds from exercise of warrants |
17,854
|
|
Proceeds from issuance of shares and warrants, net |
|
37,534
|
Net cash provided by financing activities |
17,854
|
37,534
|
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS |
(14)
|
(23)
|
INCREASE IN CASH AND CASH EQUIVALENTS |
18,745
|
6,913
|
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD |
9,640
|
4,632
|
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF THE PERIOD |
28,385
|
11,545
|
SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES: |
|
|
Issuance Costs not yet paid |
$ 1,000
|
|
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v3.24.2.u1
DESCRIPTION OF BUSINESS
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
DESCRIPTION OF BUSINESS |
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. |
|
|
|
|
|
The
Company markets its products through distributors in international markets, mainly in Europe. |
|
|
|
|
|
As
of the date of issuance of the condensed consolidated financial statements, the Company has the ability to fund its planned
operations for at least the next 12 months. However, the Company expects to continue incurring losses and negative cash flows from
operations until its product, CGuard™ EPS, reaches commercial profitability. Therefore, in order to fund the Company’s
operations until such time that the Company can generate substantial revenues, the Company may need to raise additional
funds. |
|
|
|
|
b. |
War against Hamas
|
|
|
|
|
|
In
October 2023, Israel was attacked by a terrorist organization and entered a state of war. 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 southern border (with the Houthi movement in Yemen) As of the date of these consolidated financial statements, the
war in Israel is ongoing and continues to evolve. The Company operations, including its production facility, are located in Israel.
Currently, such activities in Israel remain largely unaffected. During the six months ended June 30, 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. |
|
X |
- DefinitionThe entire disclosure for the nature of an entity's business, major products or services, principal markets including location, and the relative importance of its operations in each business and the basis for the determination, including but not limited to, assets, revenues, or earnings. For an entity that has not commenced principal operations, disclosures about the risks and uncertainties related to the activities in which the entity is currently engaged and an understanding of what those activities are being directed toward.
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v3.24.2.u1
BASIS OF PRESENTATION
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
BASIS OF PRESENTATION |
NOTE
2 - BASIS OF PRESENTATION
The
accompanying unaudited condensed consolidated financial statements have been prepared on the same basis as the annual consolidated
financial statements for the year ended December 31, 2023. 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, 2023, as found
in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 5, 2024. The results
of operations for the three and six months ended June 30, 2024, are not necessarily indicative of results that could be expected for
the entire fiscal year.
|
X |
- DefinitionThe entire disclosure for the basis of accounting, or basis of presentation, used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
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v3.24.2.u1
RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Changes and Error Corrections [Abstract] |
|
RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS |
NOTE
3 - RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS
|
|
Recently
adopted accounting pronouncements
|
|
|
|
|
|
In
August 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)
2020-06 “Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts
in Entity’s Own Equity (Subtopic 815 – 40).” This guidance simplifies the accounting for certain financial
instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own
equity. This ASU is effective for the Company for fiscal years beginning after December 15, 2023, and interim periods within those
fiscal years. The Company adopted the provisions of this update as of January 1, 2024 with no material impact on its condensed
consolidated financial statements. |
Recently
issued accounting pronouncement, not yet adopted
|
1) |
In
November 2023, the FASB issued ASU 2023-07 “Segment Reporting: Improvements to Reportable Segment Disclosures”. This
guidance expands public entities segment disclosures primarily by requiring disclosure of significant segment expenses that are
regularly provided to the chief operating decision maker and included within each reported measure of segment profit or loss, an
amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or
loss and assets. Public entities with a single reportable segment are required to provide the new disclosures and all the
disclosures required under Accounting Standards Codification (“ASC”) 280. The guidance is effective for fiscal years
beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption
permitted. The amendments are required to be applied retrospectively to all prior periods presented in an entity’s financial
statements. The Company is currently evaluating this guidance to determine the impact it may have on its condensed consolidated
financial statements related disclosures. |
|
|
|
|
2) |
In
December 2023, the FASB issued 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 condensed consolidated financial statements disclosures. |
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v3.24.2.u1
FAIR VALUE MEASUREMENTS
|
6 Months Ended |
Jun. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
FAIR VALUE MEASUREMENTS |
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:
SCHEDULE
OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
As of June 30, 2024 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Assets: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents- | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
$ | 20,340 | | |
$ | 20,340 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Marketable securities- | |
| | | |
| | | |
| | | |
| | |
U.S government bonds | |
$ | 18,778 | | |
$ | - | | |
$ | 18,778 | | |
$ | - | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
As of December 31, 2023 ($ in thousands) | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Assets: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents- | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
$ | 7,094 | | |
$ | 7,094 | | |
$ | - | | |
$ | - | |
Cash equivalents | |
$ | 7,094 | | |
$ | 7,094 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Marketable securities- | |
| | | |
| | | |
| | | |
| | |
U.S government bonds | |
$ | 29,383 | | |
$ | - | | |
$ | 29,383 | | |
$ | - | |
Marketable securities | |
$ | 29,383 | | |
$ | - | | |
$ | 29,383 | | |
$ | - | |
The
Company’s debt securities are classified within 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, 2024, is $18,137 thousand.
The cost of marketable securities as of December 31, 2023 is $28,727
thousand.
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v3.24.2.u1
MARKETABLE SECURITIES
|
6 Months Ended |
Jun. 30, 2024 |
Investments, Debt and Equity Securities [Abstract] |
|
MARKETABLE SECURITIES |
NOTE
5 - MARKETABLE SECURITIES
The
following table sets forth the Company’s marketable securities for the indicated periods:
SCHEDULE
OF MARKETABLE SECURITIES
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
($ in thousands) | |
U.S government bonds | |
$ | 18,778 | | |
$ | 29,383 | |
Marketable securities | |
$ | 18,778 | | |
$ | 29,383 | |
The
following table summarizes the fair value of the Company’s marketable securities classified by maturity as of June 30, 2024, and
December 31, 2023:
SCHEDULE
OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY
|
|
June
30, |
|
|
December
31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
($
in thousands) |
|
Amounts
maturing within one year |
|
$ |
18,778 |
|
|
$ |
24,523 |
|
Amounts
maturing after one year through two years |
|
|
- |
|
|
|
4,860 |
|
|
|
$ |
18,778 |
|
|
$ |
29,383 |
|
The
table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the six months period
ended June 30, 2024:
SCHEDULE
OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES
| |
Six months ended June 30, | |
|
Six months ended June 30,
|
|
| |
2024 | |
|
2023 |
|
| |
($ in thousands) |
|
| |
| |
|
|
|
Balance at beginning of the period | |
$ | 29,383 | |
|
|
- |
|
Maturity | |
| (13,000 | ) |
|
|
|
|
Interest received | |
| (122 | ) |
|
|
|
|
Changes in fair value during the period | |
| 557 | |
|
|
(21 |
) |
Balance at end of the period | |
| 18,778 | |
|
|
28,817 |
|
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- DefinitionThe entire disclosure for investments in certain debt and equity securities.
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v3.24.2.u1
EQUITY
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
EQUITY |
NOTE
6 - EQUITY:
Exercise
of Series H Warrant
The
Series H Warrants have a term of the earlier of (i) five years from the date of issuance and (ii) 20 trading days following the Company’s
public release of primary and secondary end points related to one year follow up study results from the Company’s C-GUARDIANS pivotal
trial.
Following
the announcement on May 28, 2024 of the one year follow up study results from the Company’s C-GUARDIANS pivotal trial, the
Series H warrants for the purchase of 12,914,086
shares of common stock were exercised in full into 292,996
shares of common stock and pre-funded warrants exercisable into 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 deduction of placement agent fees of $1 million. The Series H warrants, each exercisable at $1.3827
per share of common stock and $1.3826
per pre-funded warrant, were issued as part of the private placement financing that the Company consummated on May 15, 2023.
As
of June 30, 2024, there are 26,347,323 outstanding pre-funded warrants.
As
of June 30, 2024, there were 1,718 shares of Series C Preferred Stock outstanding, convertible into an aggregate of 7,952 shares of the
company’s common stock with a total stated value of $10,997.
As
of June 30, 2024, the Company has outstanding warrants to purchase an aggregate of 40,479,588 shares of common stock as follows:
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK
| |
Number of underlying Common stock | | |
Exercise price | |
Expiration date |
|
Series E Warrants | |
| 198,159 | | |
$ | 27.000 | |
September 24, 2024 |
|
Series F Warrants | |
| 433,878 | | |
$ | 7.4250 | |
June 5, 2025-October 16, 2025 |
|
Series G Warrants | |
| 1,092,344 | | |
$ | 10.230 | |
February 8, 2026 |
|
Series I Warrants | |
| 12,914,078 | | |
$ | 1.3827 | |
-* |
|
Series J Warrants | |
| 12,914,086 | | |
$ | 1.3827 | |
-* |
|
Series K Warrants | |
| 12,914,078 | | |
$ | 1.3827 | |
-* |
|
Underwriter Warrants | |
| 12,965 | | |
$ | 7.4250 | |
September 24, 2024 |
|
Total Warrants | |
| 40,479,588 | | |
| | |
|
|
* |
● |
The Warrants have a term
of the earlier of (i) May 15, 2025 and (ii) (A) in the case of the Series I Warrants, 20 trading days following the Company’s
announcement of receipt of Premarket Approval from the Food and Drug Administration (“FDA”) for the CGuard Prime Carotid
Stent System (135 cm), (B) in the case of the Series J Warrants, 20 trading days following the Company’s announcement of receipt
of FDA approval for the SwitchGuard and CGuard Prime 80 and (C) in the case on the Series K Warrants, 20 trading days following the
end of the fourth fiscal quarter after the fiscal quarter in which the first commercial sales of the CGuard Carotid Stent System in
the United States begins. |
As
of June 30, 2024, the Company had 155,000,000 authorized shares of capital stock, par value $0.0001 per share, of which 150,000,000 are
shares of common stock and 5,000,000 are shares of “blank check” preferred stock.
During
the six months ended June 30, 2024, the Company granted 1,634,403
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 $5.07 million.
During
the six months ended June 30, 2024, the Company granted 563,499 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 $1.77 million.
During
the six months ended June 30, 2024, the Company granted to employees and directors options to purchase a total of 715,614 shares of the
Company’s common stock. The options have exercise prices ranging from $2.71-$3.14 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 0% and expected term of
5.5-6.5 years; expected volatility ranging from 96.40%-119.38%; and risk-free interest rate ranging from 3.93%-4.10%.
The
fair value of the above options, using the Black-Scholes option-pricing model, was approximately $1.85 million.
On
April 1, 2024, the Company granted to consultants options to purchase a total of 125,000 shares of the Company’s common stock.
The options have an exercise price of $2.37 per share, which was the fair market value of the Company’s common stock on the date
of the grant. 25,000 options are subject to a two-year vesting period (of which 12,500 options are vesting in the first year and 12,500
options are vesting in the second year) and 100,000 options with performance conditions related to clinical activities.
In
calculating the fair value of the above options, the Company used the following assumptions: dividend yield of 0% and expected term of
5.125-6 years; expected volatility ranging from 96.01%-100.76%; and risk-free interest rate ranging from 4.33%-4.34%.
The
fair value of the above options, using the Black-Scholes option-pricing model, was $233,169.
|
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v3.24.2.u1
RELATED PARTIES TRANSACTIONS
|
6 Months Ended |
Jun. 30, 2024 |
Related Party Transactions [Abstract] |
|
RELATED PARTIES TRANSACTIONS |
NOTE
7 – RELATED PARTIES TRANSACTIONS
During
the six and three months ended June 30, 2024, 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 amount of $30,000 and $15,000, respectively.
|
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v3.24.2.u1
NET LOSS PER SHARE
|
6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
NET LOSS PER SHARE |
NOTE
8 - NET LOSS PER SHARE:
Basic
and diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of shares of common
stock, pre-funded warrants and fully vested restricted stock units outstanding during the period. The calculation of diluted net loss
per share excludes the effect of potential dilution of share options, warrants, and unvested restricted stocks, unvested restricted stock
units and Series C preferred stock as the effect is anti-dilutive.
For
the purpose of calculating basic net loss per share, the additional shares of common stock that are issuable upon exercise of the pre-funded
warrants have been included since the shares are issuable for a negligible consideration, as determined by the Company according to ASC
260-10-45-13, and have no vesting nor any other contingencies associated with them. For the six and three-month periods ended June 30, 2024,
we had weighted average pre-funded warrants of 15,385,212 and 15,515,802, respectively, which were used in the computations of net loss
per share for the six and three-month periods.
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 excluded from the calculations of diluted loss per share were 48,550,189 and 59,624,929 for the six
and three-month periods ended June 30, 2024 and 2023, respectively. This amount includes 3,744,828
and 2,905,615 of unvested restricted stock included in the number of issued and outstanding shares as of June 30, 2024 and 2023, respectively.
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v3.24.2.u1
FINANCIAL INSTRUMENTS
|
6 Months Ended |
Jun. 30, 2024 |
Investments, All Other Investments [Abstract] |
|
FINANCIAL INSTRUMENTS |
NOTE
9 - 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 or due
to the relatively short-term maturities of such instruments.
|
b. |
As of June 30, 2024, and December 31, 2023, allowance for expected
credit loss was immaterial. |
|
X |
- DefinitionThe entire disclosure for financial instruments. This disclosure includes, but is not limited to, fair value measurements of short and long term marketable securities, international currencies forward contracts, and auction rate securities. Financial instruments may include hedging and non-hedging currency exchange instruments, derivatives, securitizations and securities available for sale at fair value. Also included are investment results, realized and unrealized gains and losses as well as impairments and risk management disclosures.
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v3.24.2.u1
INVENTORY
|
6 Months Ended |
Jun. 30, 2024 |
Inventory Disclosure [Abstract] |
|
INVENTORY |
NOTE
10- INVENTORY:
SCHEDULE
OF INVENTORIES
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
($ in thousands) | |
Finished goods | |
$ | 124 | | |
$ | 210 | |
Work in process | |
| 537 | | |
| 562 | |
Raw materials and supplies | |
| 1,545 | | |
| 1,334 | |
Total
inventory | |
$ | 2,206 | | |
$ | 2,106 | |
|
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v3.24.2.u1
ACCOUNTS PAYABLE AND ACCRUALS - OTHER
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
ACCOUNTS PAYABLE AND ACCRUALS - OTHER |
NOTE
11 - ACCOUNTS PAYABLE AND ACCRUALS - OTHER:
SCHEDULE
OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
($ in thousands) | |
Employees and employee institutions | |
| 1,656 | | |
| 2,188 | |
Accrued vacation and recreation pay | |
| 384 | | |
| 287 | |
Accrued expenses | |
| 1,149 | | |
| 1,115 | |
Issuance costs not yet paid | |
| 1,000 | | |
| - | |
Clinical trial accrual | |
| 1,128 | | |
| 744 | |
Current Operating lease liabilities | |
| 538 | | |
| 557 | |
Other | |
| 183 | | |
| 190 | |
Accounts Payable and
Accruals - Other | |
| 6,038 | | |
| 5,081 | |
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.24.2.u1
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES
|
6 Months Ended |
Jun. 30, 2024 |
Segment Reporting [Abstract] |
|
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES |
NOTE
12 - DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES:
Revenues
are attributed to geographic areas based on the location of the customers. The following is a summary of revenues:
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
Three
months ended
June 30, |
|
|
Six
months ended
June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
($
in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Germany |
|
$ |
307 |
|
|
$ |
276 |
|
|
$ |
549 |
|
|
$ |
490 |
|
Italy |
|
|
264 |
|
|
|
338 |
|
|
|
558 |
|
|
|
605 |
|
Poland |
|
|
207 |
|
|
|
79 |
|
|
|
359 |
|
|
|
198 |
|
Other* |
|
|
961 |
|
|
|
956 |
|
|
|
1,784 |
|
|
|
1,595 |
|
Revenues |
|
$ |
1,739 |
|
|
$ |
1,649 |
|
|
$ |
3,250 |
|
|
$ |
2,888 |
|
|
* |
No single country included in other generated more than 10%
of total revenue |
By
principal customers:
SCHEDULE
OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
Three
months ended
June 30, |
|
|
Six
months ended
June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Customer
A |
|
|
18% |
|
|
|
17% |
|
|
|
17% |
|
|
|
17% |
|
Customer
B |
|
|
12% |
|
|
|
5% |
|
|
|
11% |
|
|
|
7% |
|
Customer
C |
|
|
6% |
|
|
|
11% |
|
|
|
9% |
|
|
|
12% |
|
All
substantially tangible long lived assets are located in Israel.
|
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v3.24.2.u1
FAIR VALUE MEASUREMENTS (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Fair Value Disclosures [Abstract] |
|
SCHEDULE OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS |
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:
SCHEDULE
OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
As of June 30, 2024 | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Assets: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents- | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
$ | 20,340 | | |
$ | 20,340 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Marketable securities- | |
| | | |
| | | |
| | | |
| | |
U.S government bonds | |
$ | 18,778 | | |
$ | - | | |
$ | 18,778 | | |
$ | - | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
As of December 31, 2023 ($ in thousands) | |
| |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Assets: | |
| | | |
| | | |
| | | |
| | |
Cash equivalents- | |
| | | |
| | | |
| | | |
| | |
Money market funds | |
$ | 7,094 | | |
$ | 7,094 | | |
$ | - | | |
$ | - | |
Cash equivalents | |
$ | 7,094 | | |
$ | 7,094 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
| |
| | | |
| | | |
| | | |
| | |
Marketable securities- | |
| | | |
| | | |
| | | |
| | |
U.S government bonds | |
$ | 29,383 | | |
$ | - | | |
$ | 29,383 | | |
$ | - | |
Marketable securities | |
$ | 29,383 | | |
$ | - | | |
$ | 29,383 | | |
$ | - | |
|
X |
- DefinitionTabular disclosure of assets, including [financial] instruments measured at fair value that are classified in stockholders' equity, if any, by class that are measured at fair value on a recurring basis. The disclosures contemplated herein include the fair value measurements at the reporting date by the level within the fair value hierarchy in which the fair value measurements in their entirety fall, segregating fair value measurements using quoted prices in active markets for identical assets (Level 1), significant other observable inputs (Level 2), and significant unobservable inputs (Level 3).
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v3.24.2.u1
MARKETABLE SECURITIES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Investments, Debt and Equity Securities [Abstract] |
|
SCHEDULE OF MARKETABLE SECURITIES |
The
following table sets forth the Company’s marketable securities for the indicated periods:
SCHEDULE
OF MARKETABLE SECURITIES
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
($ in thousands) | |
U.S government bonds | |
$ | 18,778 | | |
$ | 29,383 | |
Marketable securities | |
$ | 18,778 | | |
$ | 29,383 | |
|
SCHEDULE OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY |
The
following table summarizes the fair value of the Company’s marketable securities classified by maturity as of June 30, 2024, and
December 31, 2023:
SCHEDULE
OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY
|
|
June
30, |
|
|
December
31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
($
in thousands) |
|
Amounts
maturing within one year |
|
$ |
18,778 |
|
|
$ |
24,523 |
|
Amounts
maturing after one year through two years |
|
|
- |
|
|
|
4,860 |
|
|
|
$ |
18,778 |
|
|
$ |
29,383 |
|
|
SCHEDULE OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES |
The
table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the six months period
ended June 30, 2024:
SCHEDULE
OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES
| |
Six months ended June 30, | |
|
Six months ended June 30,
|
|
| |
2024 | |
|
2023 |
|
| |
($ in thousands) |
|
| |
| |
|
|
|
Balance at beginning of the period | |
$ | 29,383 | |
|
|
- |
|
Maturity | |
| (13,000 | ) |
|
|
|
|
Interest received | |
| (122 | ) |
|
|
|
|
Changes in fair value during the period | |
| 557 | |
|
|
(21 |
) |
Balance at end of the period | |
| 18,778 | |
|
|
28,817 |
|
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v3.24.2.u1
EQUITY (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK |
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK
| |
Number of underlying Common stock | | |
Exercise price | |
Expiration date |
|
Series E Warrants | |
| 198,159 | | |
$ | 27.000 | |
September 24, 2024 |
|
Series F Warrants | |
| 433,878 | | |
$ | 7.4250 | |
June 5, 2025-October 16, 2025 |
|
Series G Warrants | |
| 1,092,344 | | |
$ | 10.230 | |
February 8, 2026 |
|
Series I Warrants | |
| 12,914,078 | | |
$ | 1.3827 | |
-* |
|
Series J Warrants | |
| 12,914,086 | | |
$ | 1.3827 | |
-* |
|
Series K Warrants | |
| 12,914,078 | | |
$ | 1.3827 | |
-* |
|
Underwriter Warrants | |
| 12,965 | | |
$ | 7.4250 | |
September 24, 2024 |
|
Total Warrants | |
| 40,479,588 | | |
| | |
|
|
* |
● |
The Warrants have a term
of the earlier of (i) May 15, 2025 and (ii) (A) in the case of the Series I Warrants, 20 trading days following the Company’s
announcement of receipt of Premarket Approval from the Food and Drug Administration (“FDA”) for the CGuard Prime Carotid
Stent System (135 cm), (B) in the case of the Series J Warrants, 20 trading days following the Company’s announcement of receipt
of FDA approval for the SwitchGuard and CGuard Prime 80 and (C) in the case on the Series K Warrants, 20 trading days following the
end of the fourth fiscal quarter after the fiscal quarter in which the first commercial sales of the CGuard Carotid Stent System in
the United States begins. |
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v3.24.2.u1
INVENTORY (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Inventory Disclosure [Abstract] |
|
SCHEDULE OF INVENTORIES |
SCHEDULE
OF INVENTORIES
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
($ in thousands) | |
Finished goods | |
$ | 124 | | |
$ | 210 | |
Work in process | |
| 537 | | |
| 562 | |
Raw materials and supplies | |
| 1,545 | | |
| 1,334 | |
Total
inventory | |
$ | 2,206 | | |
$ | 2,106 | |
|
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v3.24.2.u1
ACCOUNTS PAYABLE AND ACCRUALS - OTHER (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER |
SCHEDULE
OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER
| |
June 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
($ in thousands) | |
Employees and employee institutions | |
| 1,656 | | |
| 2,188 | |
Accrued vacation and recreation pay | |
| 384 | | |
| 287 | |
Accrued expenses | |
| 1,149 | | |
| 1,115 | |
Issuance costs not yet paid | |
| 1,000 | | |
| - | |
Clinical trial accrual | |
| 1,128 | | |
| 744 | |
Current Operating lease liabilities | |
| 538 | | |
| 557 | |
Other | |
| 183 | | |
| 190 | |
Accounts Payable and
Accruals - Other | |
| 6,038 | | |
| 5,081 | |
|
X |
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v3.24.2.u1
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Segment Reporting [Abstract] |
|
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS |
Revenues
are attributed to geographic areas based on the location of the customers. The following is a summary of revenues:
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
Three
months ended
June 30, |
|
|
Six
months ended
June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
($
in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Germany |
|
$ |
307 |
|
|
$ |
276 |
|
|
$ |
549 |
|
|
$ |
490 |
|
Italy |
|
|
264 |
|
|
|
338 |
|
|
|
558 |
|
|
|
605 |
|
Poland |
|
|
207 |
|
|
|
79 |
|
|
|
359 |
|
|
|
198 |
|
Other* |
|
|
961 |
|
|
|
956 |
|
|
|
1,784 |
|
|
|
1,595 |
|
Revenues |
|
$ |
1,739 |
|
|
$ |
1,649 |
|
|
$ |
3,250 |
|
|
$ |
2,888 |
|
|
* |
No single country included in other generated more than 10%
of total revenue |
|
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS |
By
principal customers:
SCHEDULE
OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
|
Three
months ended
June 30, |
|
|
Six
months ended
June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
Customer
A |
|
|
18% |
|
|
|
17% |
|
|
|
17% |
|
|
|
17% |
|
Customer
B |
|
|
12% |
|
|
|
5% |
|
|
|
11% |
|
|
|
7% |
|
Customer
C |
|
|
6% |
|
|
|
11% |
|
|
|
9% |
|
|
|
12% |
|
|
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v3.24.2.u1
SCHEDULE OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Marketable securities |
$ 18,137
|
$ 28,727
|
Fair Value, Recurring [Member] | US Government Agencies Debt Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Marketable securities |
18,778
|
29,383
|
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 1 [Member] | US Government Agencies Debt Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Marketable securities |
|
|
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 2 [Member] | US Government Agencies Debt Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Marketable securities |
18,778
|
29,383
|
Fair Value, Recurring [Member] | Fair Value, Inputs, Level 3 [Member] | US Government Agencies Debt Securities [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Marketable securities |
|
|
Fair Value, Recurring [Member] | Money Market Funds [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents |
20,340
|
7,094
|
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
Cash equivalents |
20,340
|
7,094
|
Fair Value, Recurring [Member] | Money Market Funds [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] |
|
|
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|
|
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|
|
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|
|
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|
|
X |
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SCHEDULE OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Jun. 30, 2023 |
Dec. 31, 2022 |
Investments, Debt and Equity Securities [Abstract] |
|
|
|
|
Amounts maturing within one year |
$ 18,778
|
$ 24,523
|
|
|
Amounts maturing after one year through two years |
|
4,860
|
|
|
Marketable securities |
$ 18,778
|
$ 29,383
|
$ 28,817
|
|
X |
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v3.24.2.u1
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK (Details)
|
6 Months Ended |
Jun. 30, 2024
$ / shares
shares
|
Class of Stock [Line Items] |
|
|
Total Warrants |
40,479,588
|
|
Series E Warrants [Member] |
|
|
Class of Stock [Line Items] |
|
|
Total Warrants |
198,159
|
|
Weighted average exercise price | $ / shares |
$ 27.000
|
|
Expiration date |
Sep. 24, 2024
|
|
Series F Warrants [Member] |
|
|
Class of Stock [Line Items] |
|
|
Total Warrants |
433,878
|
|
Weighted average exercise price | $ / shares |
$ 7.4250
|
|
Expiration date |
June 5, 2025-October 16, 2025
|
|
Series G Warrants [Member] |
|
|
Class of Stock [Line Items] |
|
|
Total Warrants |
1,092,344
|
|
Weighted average exercise price | $ / shares |
$ 10.230
|
|
Expiration date |
Feb. 08, 2026
|
|
Series I Warrants [Member] |
|
|
Class of Stock [Line Items] |
|
|
Total Warrants |
12,914,078
|
|
Weighted average exercise price | $ / shares |
$ 1.3827
|
|
Expiration date |
|
[1] |
Series J Warrants [Member] |
|
|
Class of Stock [Line Items] |
|
|
Total Warrants |
12,914,086
|
|
Weighted average exercise price | $ / shares |
$ 1.3827
|
|
Expiration date |
|
[1] |
Series K Warrants [Member] |
|
|
Class of Stock [Line Items] |
|
|
Total Warrants |
12,914,078
|
|
Weighted average exercise price | $ / shares |
$ 1.3827
|
|
Expiration date |
|
[1] |
Underwriter Warrants [Member] |
|
|
Class of Stock [Line Items] |
|
|
Total Warrants |
12,965
|
|
Weighted average exercise price | $ / shares |
$ 7.4250
|
|
Expiration date |
Sep. 24, 2024
|
|
|
|
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v3.24.2.u1
EQUITY (Details Narrative) - USD ($)
|
|
|
|
3 Months Ended |
6 Months Ended |
|
May 28, 2024 |
Apr. 01, 2024 |
May 15, 2023 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Dec. 31, 2023 |
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Warrants to purchase common stock |
|
|
|
|
|
40,479,588
|
|
|
Warrants exercise |
|
|
|
|
|
$ 17,854,000
|
|
|
Preferred stock stated value |
[1] |
|
|
|
|
|
|
|
Capital stock shares authorized |
|
|
|
|
|
155,000,000
|
|
|
Capital stock par value |
|
|
|
|
|
$ 0.0001
|
|
|
Common stock shares authorized |
|
|
|
|
|
150,000,000
|
|
150,000,000
|
Restricted Stock [Member] | Employees and Directors [Member] |
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Shares granted |
|
|
|
|
|
1,634,403
|
|
|
Fair value of shares granted |
|
|
|
|
|
$ 5,070,000.00
|
|
|
Restricted Stock Units (RSUs) [Member] | Chief Executive Officer [Member] |
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Shares granted |
|
|
|
|
|
563,499
|
|
|
Fair value of shares granted |
|
|
|
|
|
$ 1,770,000
|
|
|
Share-Based Payment Arrangement, Option [Member] | Employees and Directors [Member] |
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Option granted to consultants |
|
|
|
|
|
715,614
|
|
|
Expected dividend rate |
|
|
0.00%
|
|
|
0.00%
|
|
|
Expected volatility, minimum |
|
|
96.01%
|
|
|
96.40%
|
|
|
Expected volatility, maximum |
|
|
100.76%
|
|
|
119.38%
|
|
|
Fair value stock option price |
|
|
$ 233,169
|
|
|
$ 1,850,000
|
|
|
Share-Based Payment Arrangement, Option [Member] | Employees and Directors [Member] | Minimum [Member] |
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Stock option exercise price |
|
|
|
|
|
$ 2.71
|
|
|
Expected term |
|
|
5 years 1 month 15 days
|
|
|
5 years 6 months
|
|
|
Risk-free interest rate, maximum |
|
|
4.33%
|
|
|
3.93%
|
|
|
Share-Based Payment Arrangement, Option [Member] | Employees and Directors [Member] | Maximum [Member] |
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Stock option exercise price |
|
|
|
|
|
$ 3.14
|
|
|
Expected term |
|
|
6 years
|
|
|
6 years 6 months
|
|
|
Risk-free interest rate, maximum |
|
|
4.34%
|
|
|
4.10%
|
|
|
Share-Based Payment Arrangement, Option [Member] | Consultants [Member] |
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Option granted to consultants |
|
|
125,000
|
|
|
|
|
|
Stock option exercise price |
|
|
$ 2.37
|
|
|
|
|
|
Number of options vesting in period |
|
|
25,000
|
|
|
|
|
|
Share-Based Payment Arrangement, Option [Member] | Consultants [Member] | Performance Conditions [Member] |
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Number of options vesting in period |
|
|
100,000
|
|
|
|
|
|
Share-Based Payment Arrangement, Option [Member] | Consultants [Member] | First Year Vesting Period [Member] |
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Number of options vesting in period |
|
|
12,500
|
|
|
|
|
|
Share-Based Payment Arrangement, Option [Member] | Consultants [Member] | Second Year Vesting Period [Member] |
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Number of options vesting in period |
|
|
12,500
|
|
|
|
|
|
Pre Funded Warrants [Member] |
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Issuance of shares |
|
12,621,090
|
|
|
|
|
|
|
Placement agent fees |
|
$ 1,000,000
|
|
|
|
|
|
|
Warrants outstanding |
|
|
|
|
|
26,347,323
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Issuance of shares |
|
|
|
|
10,266,270
|
|
10,266,270
|
|
Warrant [Member] | At The Market Offering [Member] |
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Warrants to purchase common stock |
|
|
|
|
|
40,479,588
|
|
|
Preferred Stock Blank Check [Member] |
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Preferred stock shares authorized |
|
|
|
|
|
5,000,000
|
|
|
Series H Warrant [Member] |
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Warrant term |
|
|
|
|
|
5 years
|
|
|
Warrants to purchase common stock |
|
12,914,086
|
|
|
|
|
|
|
Issuance of shares |
|
292,996
|
|
|
|
|
|
|
Warrants exercise |
|
|
|
$ 16,900,000
|
|
|
|
|
Series H Warrant [Member] | Pre Funded Warrants [Member] |
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Warrants exercise price |
|
$ 1.3826
|
|
|
|
|
|
|
Series H Warrant [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Warrants exercise price |
|
$ 1.3827
|
|
|
|
|
|
|
Series C Preferred Stock [Member] |
|
|
|
|
|
|
|
|
Class of Stock [Line Items] |
|
|
|
|
|
|
|
|
Preferred stock, shares outstanding |
|
|
|
|
|
1,718
|
|
1,718
|
Preferred stock convertible shares issuable |
|
|
|
|
|
7,952
|
|
|
Preferred stock stated value |
|
|
|
|
|
$ 10,997
|
|
|
Preferred stock shares authorized |
|
|
|
|
|
1,172,000
|
|
1,172,000
|
|
|
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NET LOSS PER SHARE (Details Narrative) - shares
|
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] |
|
|
|
|
Weighted average prefunded warrants |
15,515,802
|
|
15,385,212
|
|
Unvested restricted stock |
3,744,828
|
2,905,615
|
3,744,828
|
2,905,615
|
Series C Preferred Stock [Member] |
|
|
|
|
Earnings Per Share, Basic, by Common Class, Including Two Class Method [Line Items] |
|
|
|
|
Diluted loss per share |
48,550,189
|
59,624,929
|
48,550,189
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SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Payables and Accruals [Abstract] |
|
|
Employees and employee institutions |
$ 1,656
|
$ 2,188
|
Accrued vacation and recreation pay |
384
|
287
|
Accrued expenses |
1,149
|
1,115
|
Issuance costs not yet paid |
1,000
|
|
Clinical trial accrual |
1,128
|
744
|
Current Operating lease liabilities |
538
|
557
|
Other |
183
|
190
|
Accounts Payable and Accruals - Other |
$ 6,038
|
$ 5,081
|
X |
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SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
|
|
|
Revenues |
|
$ 1,739
|
$ 1,649
|
$ 3,250
|
$ 2,888
|
GERMANY |
|
|
|
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
|
|
|
Revenues |
|
307
|
276
|
549
|
490
|
ITALY |
|
|
|
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
|
|
|
Revenues |
|
264
|
338
|
558
|
605
|
POLAND |
|
|
|
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
|
|
|
Revenues |
|
207
|
79
|
359
|
198
|
Other Countries [Member] |
|
|
|
|
|
Revenues from External Customers and Long-Lived Assets [Line Items] |
|
|
|
|
|
Revenues |
[1] |
$ 961
|
$ 956
|
$ 1,784
|
$ 1,595
|
|
|
X |
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