Item 1. Financial Statements
Item
1. Financial Statements
INSPIREMD,
INC.
CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
AS
OF AND FOR THE QUARTER ENDED SEPTEMBER 30, 2025
TABLE
OF CONTENTS
Page
CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED):
Condensed Consolidated Balance Sheets
F-2
- F-3
Condensed Consolidated Statements of Operations
F-4
Condensed Consolidated Statements of Changes in Equity
F-5
- F-8
Condensed Consolidated Statements of Cash Flows
F-9
Notes to the Condensed Consolidated Financial Statements
F-10
- F-18
F- 1
INSPIREMD,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(U.S.
dollars in thousands, except share and per share data)
September 30,
December 31,
2025
2024
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$ 63,403
$ 18,916
Marketable securities
-
15,721
Accounts receivable:
Trade, net
1,961
1,572
Other
475
682
Prepaid expenses
945
1,060
Inventory
3,607
2,570
TOTAL CURRENT ASSETS
70,391
40,521
NON-CURRENT ASSETS:
Long term deposit
438
426
Property, plant and equipment, net
3,403
2,371
Operating lease right of use assets
2,915
2,360
Fund in respect of employee rights upon retirement
1,325
1,129
TOTAL NON-CURRENT ASSETS
8,081
6,286
TOTAL ASSETS
$ 78,472
$ 46,807
F- 2
INSPIREMD,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(U.S.
dollars in thousands other than share and per share data)
September 30,
December 31,
2025
2024
LIABILITIES AND EQUITY
CURRENT LIABILITIES:
Accounts payable and accruals:
Trade
1,753
1,254
Other
9,063
6,424
TOTAL CURRENT LIABILITIES
10,816
7,678
LONG-TERM LIABILITIES-
Operating lease liabilities net of current maturities
2,367
1,796
Liability for employees’ rights upon retirement and others
1,175
1,247
TOTAL LONG-TERM LIABILITIES
3,542
3,043
TOTAL LIABILITIES
14,358
10,721
COMMITMENTS AND CONTINGENT LIABILITIES
-
-
EQUITY:
Common stock, par value $ 0.0001 per share; 150,000,000 shares authorized at September 30, 2025 and December 31, 2024; 41,919,141 and 26,611,033 shares issued and outstanding at September 30, 2025 and December 31, 2024, respectively
4
3
Preferred C shares, par value $ 0.0001 per share;
1,172,000 shares authorized at September 30, 2025 and December 31, 2024; 1,718 shares issued and outstanding at September 30, 2025 and December 31 2024, respectively
- *
- *
Additional paid-in capital
354,641
289,589
Accumulated deficit
( 290,531 )
( 253,506 )
Total equity
64,114
36,086
Total liabilities and equity
$ 78,472
$ 46,807
* Represents an amount
less than $1 thousand
The
accompanying notes are an integral part of the condensed consolidated financial statements.
F- 3
INSPIREMD,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(U.S.
dollars in thousands, except share and per share data)
2025
2024
2025
2024
Three months ended
September 30,
Nine months ended
September 30,
2025
2024
2025
2024
REVENUES
$ 2,523
$ 1,810
$ 5,830
$ 5,060
COST OF REVENUES
1,659
1,396
4,361
4,023
GROSS PROFIT
864
414
1,469
1,037
OPERATING EXPENSES:
Research and development
3,635
3,915
11,528
9,941
Selling and marketing
4,392
1,472
11,314
4,154
General and administrative
5,888
3,489
16,157
11,078
Total operating expenses
13,915
8,876
38,999
25,173
LOSS FROM OPERATIONS
( 13,051 )
( 8,462 )
( 37,530 )
( 24,136 )
FINANCIAL INCOME, net:
343
572
505
1,305
NET LOSS
$ ( 12,708 )
$ ( 7,890 )
$ ( 37,025 )
$ ( 22,831 )
NET LOSS PER SHARE - basic and diluted
$ ( 0.17 )
$ ( 0.16 )
$ ( 0.64 )
$ ( 0.58 )
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - basic and diluted
73,466,501
48,369,412
58,245,368
39,413,004
The
accompanying notes are an integral part of the condensed consolidated financial statements.
F- 4
INSPIREMD,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(Unaudited)
(U.S.
dollars in thousands, except share data)
Shares
Amount
Shares
Amount
capital
deficit
equity
Common stock
Preferred C shares
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
-
-
-
-
-
( 22,831 )
( 22,831 )
Exercise of pre-funded warrants
1,728,382
- *
- *
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
Issuance of common shares, Included at the market offering net of $ 1 issuance costs
12,961
35
35
Share-based compensation related to stock, restricted stock,
restricted stock units and stock options award, net of forfeitures of 112,382
shares
1,844,078
- *
7,792
7,792
BALANCE AT September 30, 2024
25,719,632
3
1,718
- *
285,680
( 244,332 )
41,351
* Represents an amount
less than $1 thousand
The
accompanying notes are an integral part of the condensed consolidated financial statements.
F- 5
INSPIREMD,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(Unaudited)
(U.S.
dollars in thousands, except share data)
Common stock
Preferred C shares
Additional paid-in
Accumulated
Total
Shares
Amount
Shares
Amount
capital
deficit
equity
BALANCE AT July 1, 2024
25,196,479
3
1,718
- *
283,202
( 236,442 )
46,763
Net loss
-
-
-
-
-
( 7,890 )
( 7,890 )
Exercise of pre-funded warrants
199,992
- *
- *
Issuance of common shares, Included at the market offering net of $ 1 issuance costs
12,961
35
35
Share-based compensation related to stock, restricted stock,
restricted stock units and stock options award
310,200
2,443
2,443
BALANCE AT September 30, 2024
25,719,632
3
1,718
- *
285,680
( 244,332 )
41,351
* Represents an amount
less than $1 thousand
The
accompanying notes are an integral part of the condensed consolidated financial statements.
F- 6
INSPIREMD,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(Unaudited)
(U.S.
dollars in thousands, except share data)
Common stock
Preferred C shares
Additional paid-in
Accumulated
Total
Shares
Amount
Shares
Amount
capital
deficit
equity
BALANCE AT January 1, 2025
26,611,033
3
1,718
- *
289,589
( 253,506 )
36,086
Net loss
-
-
-
-
-
( 37,025 )
( 37,025 )
Exercise of pre-funded warrants
2,381,651
- *
- *
Issuance of common stock, included at the market offering and pre-funded warrants net of $ 3,148
issuance costs
7,510,293
1
38,713
38,714
Exercise of Warrants Series I to 10,561,685 pre-funded warrants and 2,352,393 common stock, net of $ 1,000 issuance costs
2,352,393
- *
16,855
16,855
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 322,919 shares
3,063,771
- *
9,484
9,484
BALANCE AT September 30, 2025
41,919,141
4
1,718
- *
354,641
( 290,531 )
64,114
* Represents an amount
less than $1 thousand
The
accompanying notes are an integral part of the condensed consolidated financial statements.
F- 7
INSPIREMD,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(Unaudited)
(U.S.
dollars in thousands, except share data)
Common stock
Preferred C shares
Additional paid-in
Accumulated
Total
Shares
Amount
Shares
Amount
capital
deficit
equity
BALANCE AT July 1, 2025
32,552,888
3
1,718
- *
298,063
( 277,823 )
20,243
Balance
32,552,888
3
1,718
- *
298,063
( 277,823 )
20,243
Net loss
-
-
-
-
-
( 12,708 )
( 12,708 )
Exercise of pre-funded warrants
970,098
- *
- *
Exercise of Warrants Series I to 10,561,685 pre-funded warrants and 943,641 common stock, net of $ 891 issuance costs
943,641
- *
15,017
15,017
Exercise of Warrants to pre-funded warrants and common stock,
net of issuance costs
943,641
- *
15,017
15,017
Issuance of common stock, included at the market offering and
9,764,804 pre-funded warrants net of $ 3,126
issuance costs
7,236,672
1
38,017
38,018
Issuance of common stock, included at the market offering and
pre-funded warrants net of issuance costs
7,236,672
1
38,017
38,018
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 34,712 shares
215,842
- *
3,544
3,544
Share-based compensation related to stock, restricted stock,
restricted stock units and stock options award, net of forfeitures of shares
215,842
- *
3,544
3,544
BALANCE AT September 30, 2025
41,919,141
4
1,718
- *
354,641
( 290,531 )
64,114
Balance
41,919,141
4
1,718
- *
354,641
( 290,531 )
64,114
* Represents an amount
less than $1 thousand
The
accompanying notes are an integral part of the condensed consolidated financial statements.
F- 8
INSPIREMD,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(U.S.
dollars in thousands)
2025
2024
Nine months ended
September 30
2025
2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss
$ ( 37,025 )
$ ( 22,831 )
Adjustments required to reconcile net loss to net cash used in operating activities:
Depreciation
333
205
Gain from sale of property, plant and equipment
( 15 )
-
Changes in fair value of marketable securities, net of interest received
( 178 )
( 757 )
Change in liability for employees’ rights upon retirement
371
99
Other financial income
( 113 )
( 8 )
Change in operating right of use asset and operating leasing liability
480
( 39 )
Share-based compensation expenses
9,484
7,792
Loss (gain) on amounts funded in respect of employee rights upon retirement, net
( 121 )
21
Changes in operating asset and liability items:
Decrease (increase) in prepaid expenses
115
( 698 )
Decrease (increase) in trade receivables
( 389 )
274
Decrease (increase) in other receivables
207
( 93 )
Increase in inventory
( 1,037 )
( 339 )
Increase in trade payables
499
366
Increase in other payables
1,631
890
Net cash used in operating activities
( 25,758 )
( 15,118 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property, plant and equipment
( 1,264 )
( 1,091 )
Proceeds from sale of property, plant and equipment
15
-
Investments in marketable securities
( 11,749 )
( 14,444 )
Proceeds from matured marketable securities
27,648
20,000
Amounts funded in respect of employee rights upon retirement
( 75 )
( 66 )
Net cash provided by investing activities
14,575
4,399
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from exercise of warrants, net of $ 1,000
issuance costs
16,855
16,854
Proceeds from issuance of shares and pre-funded warrants, net of $ 3,148
and $ 1
issuance costs, respectively
38,714
35
Net cash provided by financing activities
55,569
16,889
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS
101
8
INCREASE IN CASH AND CASH EQUIVALENTS
44,487
6,178
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD
18,916
9,640
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF THE PERIOD
$ 63,403
$ 15,818
SUPPLEMENTAL NON-CASH INVESTING AND FINANCING ACTIVITIES:
Acquisition of right-of-use assets by means of lease liabilities
994
-
Non- cash purchase of property and equipment
101
-
The
accompanying notes are an integral part of the condensed consolidated financial statements.
F- 9
INSPIREMD,
INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
1 - DESCRIPTION OF BUSINESS
a.
General
InspireMD, Inc., a Delaware corporation (the “Company”), together with its subsidiaries, is a medical device company focusing on the development and commercialization of its proprietary MicroNet™ stent platform technology for the treatment of complex vascular and coronary disease. MicroNet, a micron mesh sleeve, is wrapped over a stent to provide embolic protection in stenting procedures.
The Company’s carotid product (CGuard™ EPS) combines MicroNet
and a self-expandable nitinol stent in a single device to treat carotid artery disease.
On
June 13, 2025, the Company received CE Mark approval under the European Medical Device Regulation for the CGuard Prime carotid stent
system. On June 23, 2025, the U.S. Food and Drug Administration (“FDA”) granted premarket application (PMA) approval
of the CGuard Prime Carotid Stent System in the United States, and in July 2025, the Company announced the official commercial launch
of the CGuard Prime carotid stent system in the United States. In the United States, following FDA approval of the PMA of the CGuard
Prime Carotid Stent System, the Company markets and sells its product through a direct sales organization. In addition, the Company
also markets and sells its product through distributors in international markets, mainly in Europe.
b .
Liquidity
The
Company has an accumulated deficit as of September 30, 2025, as well as a history of net losses and negative operating cash flows.
The Company expects to continue incurring losses and negative cash flows from operations until its product, CGuard™ EPS, reaches
commercial profitability. As a result of these expected losses and negative cash flows from operations, along with the Company’s
current cash position, the Company does not have sufficient resources to fund operations for at least the next 12 months. Therefore,
there is substantial doubt about the Company’s ability to continue as a going concern. These financial statements have been
prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the
outcome of this uncertainty.
Management’s
plans include the continued commercialization of the Company’s product and raising capital through the sale of additional equity
securities, debt or capital inflows from strategic partnerships and exercise of warrants. There are no assurances however, that the
Company will be successful in obtaining the level of financing needed for its operations. If the Company is unsuccessful in commercializing
its products and raising capital, it may need to reduce activities, curtail or cease operations.
c.
Risks
Related to the Company’s Operations in Israel
In
October 2023, Israel was attacked by the Hamas terrorist organization and entered a state of war on several fronts. In June 2025, following
escalating threats and intelligence reports of imminent attacks, Israel conducted preemptive strikes on military and nuclear infrastructure
in Iran. Iran responded with drones and missiles attacks, some of which caused civilian casualties and infrastructure damage. After 12
days of hostilities, a ceasefire between Israel and Iran was reached in June 2025. As of October 9, 2025, Israel and Hamas entered into
a ceasefire agreement calling for a permanent end of the war. However, there are no assurances that such agreements will hold. As a result,
while the ceasefire marks a potential shift towards stability in the region, the situation remains volatile, and the risk of broader
regional escalation involving additional actors persists. As of the date of these consolidated financial statements, conflict continues
in parts of the region. The Company’s operations, including its current production facility, are located in Israel. At this time,
these activities remain largely unaffected.
During
the nine and three months ended September 30, 2025 and 2024, the impact of this war on the Company’s results of operations and
financial condition was immaterial, but such impact may increase, which could be material, as a result of the continuation, escalation
or expansion of such war.
F- 10
INSPIREMD,
INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
2 - BASIS OF PRESENTATION
The
accompanying unaudited consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements.
In the opinion of the company, all adjustments considered necessary for a fair statement of the results of the interim periods reported
herein have been included (consisting only of normal recurring adjustments). These condensed consolidated financial statements and notes
thereto are unaudited and should be read in conjunction with the Company’s audited financial statements for the year ended December
31, 2024, as found in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 12,
2025. The results of operations for the nine and three months ended September 30, 2025 are not necessarily indicative of results that
could be expected for the entire fiscal year.
NOTE
3 - RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS
Recently
issued accounting pronouncement, not yet adopted
1)
In
December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”)
2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures”. This guidance is intended to enhance the
transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced
income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S.
and in foreign jurisdictions. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective basis,
with the option to apply the standard retrospectively. Early adoption is permitted. The Company is currently evaluating this guidance
to determine the impact it may have on its consolidated financial statements and disclosures.
2)
In
November 2024, the FASB issued ASU No. 2024-03 Income Statement—Reporting Comprehensive Income—Expense Disaggregation
Disclosures (Subtopic 220-40). The ASU improves the disclosures about a public business entity’s expenses and provides more
detailed information about the types of expenses in commonly presented expense captions. The amendments require that at each interim
and annual reporting period an entity will, inter alia, disclose amounts of purchases of inventory, employee compensation, depreciation
and amortization included in each relevant expense caption (such as cost of sales, G&A, S&M and research and development)
as well as disclosures about selling expenses. The ASU is effective for fiscal years beginning after December 15, 2026, and interim
periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating this
ASU to determine its impact on the Company’s financial statements and disclosures.
3)
In July 2025, the FASB issued Accounting Standards Update 2025-05, Financial Instruments- Credit Losses (Topic 326): Measurement of
Credit Losses for Accounts Receivable and Contract Assets (“ASU 2025-05”). ASU 2025-05 provides a practical expedient that
all entities can use when estimating expected credit losses for current accounts receivable and current contract assets arising from transactions
accounted for under ASC 606, Revenue from Contracts with Customers. Under this practical expedient, an entity is allowed to assume that
the current conditions it has applied in determining credit loss allowances for current accounts receivable and current contract assets
remain unchanged for the remaining life of those assets. ASU 2025-05 is effective for fiscal years beginning after December 15, 2025,
and interim reporting periods in those years. Entities that elect the practical expedient and, if applicable, make the accounting policy
election are required to apply the amendments prospectively. The Company is currently evaluating the potential impact of this guidance
on its consolidated financial statements and disclosures.
F- 11
INSPIREMD,
INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
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 are subject to fair value measurements on a recurring basis and the level of input 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 September 30, 2025
Total
Level 1
Level 2
Level 3
Assets:
Cash equivalents-
Money market funds
$ 53,889
$ 53,889
$ -
$ -
Total
Level
1
Level
2
Level
3
As of December 31, 2024
Total
Level 1
Level 2
Level 3
Assets:
Cash equivalents-
Money market funds
$ 6,281
$ 6,281
$ -
$ -
Marketable securities-
U.S. government bonds
$ 15,721
$ -
$ 15,721
$ -
The
Company’s cash equivalents, and marketable securities are classified within Level 1 and Level 2 because it uses quoted market prices
or alternative pricing sources and models utilizing market observable inputs to determine their fair value.
The
cost of marketable securities as of December 31, 2024, is $ 15,277 thousand. As of September 30, 2025, all marketable securities
have matured.
F- 12
INSPIREMD,
INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
5 - MARKETABLE SECURITIES
As
of December 31, 2024, all of the Company’s investment in marketable securities had contractual maturity of less than one
year.
The
table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the nine-month period
ended September 30, 2025, and 2024:
SCHEDULE
OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES
2025
2024
Nine months ended
September 30,
2025
2024
($ in thousands)
Balance at beginning of the period
$ 15,721
29,383
Additions
11,749
14,444
Maturity
( 27,648 )
( 20,000 )
Interest received
( 109 )
( 217 )
Changes in fair value during the period
287
974
Balance at end of the period
-
24,584
The
Company elected the fair value option to measure and recognize its investments in debt securities in accordance with Accounting Standards
Codification ASC 825, Financial Instruments as the Company managed and evaluated the performance on a fair value basis.
F- 13
INSPIREMD,
INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
6 - EQUITY :
a.
As
of September 30, 2025, 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 .
b.
As of September 30, 2025, there are 44,092,107 outstanding pre-funded warrants.
Prior to June 30, 2025, pre-funded warrants were exercised on a cashless basis; from July 1, 2025 through September 30, 2025, pre-funded
warrants were exercised for cash.
c.
As
of September 30, 2025, the Company has outstanding warrants to purchase an aggregate of 26,935,323 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 F Warrants
14,815
$ 7.4250
October 16, 2025
Series G Warrants
1,092,344
$ 10.230
February 8, 2026
Series J Warrants
12,914,086
$ 1.3827
*
Series K Warrants
12,914,078
$ 1.3827
*
Total Warrants
26,935,323
*
The
Series J Warrants and Series K Warrants have a term of the earlier of (i) May 15, 2028 and (ii) (A) 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
(B) 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.
On
October 16, 2025, a total of 14,815 Series F warrants expired.
d.
Exercise of Series I Warrant
Following
the Company’s announcement on June 24, 2025, that the FDA approved the PMA of the CGuard Prime Carotid Stent System in the
United States, and as of September 30, 2025, an aggregate of 12,914,078
Series I Warrants were exercised into 2,352,393
shares of common stock at an exercise price of $ 1.3827
per share and 10,561,685 pre-
funded warrants at an exercise price of $ 1.3826
per pre-funded warrant, resulting in gross proceeds of approximately $ 17,855
thousand dollars. After deducting issuance costs of $ 1,000 thousand, the net proceeds
amounted to approximately $ 16,855 thousand.
e.
Private Placement
On
July 30, 2025, the Company entered into a securities purchase agreement (the “Purchase Agreement”) with investors
pursuant to which the Company issued and sold in a private placement (the “Private Placement Offering) of an aggregate of 6,791,380 shares
(the “Private Placement Shares”) of the Company’s common stock, and pre-funded warrants (the “Pre-Funded
Warrants”) to purchase up to 9,764,804 shares
of common stock, at an offering price of $ 2.42
per Private Placement Share and $ 2.4199
per Pre-Funded Warrant. The Pre-Funded Warrants are immediately exercisable at an exercise price of $ 0.0001
per share and will not expire until exercised in full. The Private Placement Offering resulted in gross proceeds to the Company of
approximately $ 40.1
million and closed on August 1, 2025 . The issuance costs amounted to $ 3,084 thousand.
f.
During the nine months ended September 30, 2025, 718,913
shares of common stock have been sold under the ATM program for total gross proceeds of approximately $ 1.8
million and total fees of approximately $ 64 thousand.
F- 14
INSPIREMD,
INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
g.
As of September 30, 2025, 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.
h.
During
the nine months ended September 30, 2025, the Company granted 3,303,618 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 $ 8.69 million.
During
the nine months ended September 30, 2025, the Company granted 558,417 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 $ 1.54 million.
During
the nine months ended September 30, 2025, the Company granted to employees and directors options to purchase a total of 1,092,851 shares
of the Company’s common stock. The options have exercise prices ranging from $ 2.24 -$ 2.79 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 75.74 %- 92.69 %; and risk-free interest rate ranging from 3.89 %- 4.68 %.
The
fair value of the above options, using the Black-Scholes option-pricing model, was approximately $ 2.18 million.
NOTE
7 – RELATED PARTIES TRANSACTIONS
During
the nine and three months ended September 30, 2024, and 2025, a member of the immediate family of the CEO provided certain administrative
services in connection with the Company’s expansion to the U.S. in the amount of $ 55 and $ 25 thousand, for 2024, and $ 56 and $ 8
thousand for 2025, respectively. In July 2025, the engagement with the related party was terminated.
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.
The
total number of shares of common stock related to outstanding options, warrants, unvested restricted stock, unvested restricted
stock units and Series C preferred stock, which were excluded from the calculations of diluted loss per share were 37,695,155
and 48,619,222 for
the nine and three-month periods ended September 30, 2025 and 2024, respectively. This amount includes 5,385,272
and 3,979,486
of unvested restricted stock included in the number of issued and outstanding shares for the nine and three-month periods ended
September 30, 2025 and 2024, respectively.
For
the purpose of calculating basic net loss per share, the additional shares of common stock that are issuable upon exercise of the pre-funded
warrants have been included since the shares are issuable for a negligible consideration, as determined by the Company according to ASC
260-10-45-13, and have no vesting or other contingencies associated with them.
F- 15
INSPIREMD,
INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
For
the nine and three months ended September 30, 2025 and 2024, the weighted average number of ordinary shares used in computing net loss
per share - basic and diluted was as follows:
SCHEDULE
OF WEIGHTED AVERAGE NUMBER OF SHARES
2025
2024
2025
2024
Three months ended
September 30,
Nine months ended
September 30,
2025
2024
2025
2024
Weighted average number of ordinary shares
33,741,698
21,633,309
27,560,829
20,048,335
Weighted average Vested restricted stock units
1,121,678
536,606
931,022
348,383
Weighted average Pre-funded Warrants
38,603,125
26,199,497
29,753,517
19,016,286
Total Weighted average number of ordinary shares used in computing net loss per share - basic and diluted
73,466,501
48,369,412
58,245,368
39,413,004
NOTE
9 – LEASE AGREEMENTS
1)
On
May 18, 2025, the Company took possession of Suite 280 at its U.S. headquarters in Miami, Florida, following the landlord’s
completion of construction. This date represents the commencement of the lease for Suite 280, in accordance with the terms of the
U.S. Lease. In connection with the commencement, the Company recognized an increase of 302 thousand dollars in both operating lease
right-of-use assets and operating lease liabilities.
2)
On
May 28, 2025, the Company amended the Israeli Lease, extending the lease term through December 31, 2028, and leasing additional space
within the facility. The amendment resulted in an increase of 692 thousand dollars to the Company’s operating lease right-of-use
assets and lease liabilities to reflect the extended lease term and additional leased area.
NOTE
10 - FINANCIAL INSTRUMENTS :
a.
Fair
value of financial instruments
The
carrying amounts of financial instruments approximate their fair value either because these amounts are presented at fair value, due
to the relatively short-term maturities of certain instruments or they are measured using interest rates close to prevailing market rates.
b.
As
of September 30, 2025, and December 31, 2024, allowance for expected credit loss was immaterial.
F- 16
INSPIREMD,
INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
11- INVENTORY :
SCHEDULE
OF INVENTORIES
September 30,
December 31,
2025
2024
($ in thousands)
Finished goods
$ 576
$ 18
Work in process
733
638
Raw materials and supplies
2,298
1,914
Total inventory
$ 3,607
$ 2,570
NOTE
12 - ACCOUNTS PAYABLE AND ACCRUALS - OTHER :
SCHEDULE
OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER
September 30,
December 31,
2025
2024
($ in thousands)
Employees and employee institutions
5,357
3,414
Accrued vacation and recreation pay
683
369
Accrued expenses
735
1,325
Clinical trials accrual
1,013
519
Current Operating lease liabilities
1,006
542
Other
269
255
Accounts Payable and
Accruals - Other
9,063
6,424
NOTE
13 - DISAGGREGATED REVENUE :
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
2025
2024
2025
2024
Three months ended
September
30,
Nine months ended
September
30,
2025
2024
2025
2024
($ in thousands)
USA
497
7
551
29
Germany
380
306
982
855
Italy
293
306
878
865
Poland
211
176
686
534
Russia
-
190
-
375
Other *
1,142
825
2,733
2,402
Revenues
$ 2,523
$ 1,810
$ 5,830
$ 5,060
* Other
individual countries do not exceed 10% in the nine and three months ended September 30, 2025 and 2024.
By
principal customers:
SCHEDULE
OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS
2025
2024
2025
2024
Three months ended
September 30,
Nine months ended
September 30,
2025
2024
2025
2024
Customer A
15 %
17 %
17 %
17 %
Customer B
8 %
10 %
12 %
11 %
Customer C
-
11 %
-
7 %
Customer D
8 %
10 %
9 %
9 %
Sales Percentage
8 %
10 %
9 %
9 %
F- 17
INSPIREMD,
INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOTE
14 – SEGMENT INFORMATION
The
Company has one operating and reporting segment, that develops, manufactures and markets products for the treatment of carotid artery
disease and other vascular disease, including the Company’s proprietary CGuard™ stent platform. The Company’s Chief
Operating Decision Maker (“CODM”), who is the CEO evaluates the Company’s performance based on its internal reporting
which is consistent with the presentation in the Company’s consolidated financial statements. Accordingly, our CODM uses consolidated
net income to measure segment profit or loss, allocate resources, and assess performance.
The
CODM examines, within each operational function the employee salaries including the bonus and share based compensation. In addition,
the CODM examines the clinical trials expenses within the research and development operations.
SCHEDULE
OF SEGMENT REVENUE
2025
2024
2025
2024
Three months ended
September 30,
Nine months ended
September 30,
2025
2024
2025
2024
Revenues
2,523
1,810
5,830
5,060
Cost of Revenues:
Material and Labor
1,391
1,209
3,554
3,373
Other cost of revenues
268
187
807
650
Total Cost of Revenues
1,659
1,396
4,361
4,023
Research and development (R&D)
Payroll and Benefits
1,089
715
3,063
2,066
Share based compensation
576
644
1,889
1,795
Clinical trials
1,105
1,289
3,401
3,240
Other R&D
865
1,267
3,175
2,840
Total Research and development
3,635
3,915
11,528
9,941
Selling and marketing (S&M)
Payroll and Benefits
2,975
907
7,732
2,522
Share based compensation
567
277
1,379
791
Other S&M
850
288
2,203
841
Total Selling and marketing
4,392
1,472
11,314
4,154
General and administrative (G&A)
Payroll and Benefits
1,707
889
5,015
2,539
Share based compensation
2,351
1,460
6,051
4,970
Other G&A
1,830
1,140
5,091
3,569
Total General and administrative
5,888
3,489
16,157
11,078
Financial Income, net;
343
572
505
1,305
Segment net Loss
( 12,708 )
( 7,890 )
( 37,025 )
( 22,831 )
NOTE
15 – SUBSEQUENT EVENTS
Subsequent
to September 30, 2025, the Company granted an aggregate of 451,853
restricted shares of the Company’s common stock to employees, directors and consultants. Of these, 360,185
shares of common stock granted to employees and consultants are subject to a three-year vesting period, with one-third of such
awards vesting each year, 48,000
shares of common stock granted to directors are subject to a one-year vesting period and the remaining 43,668 shares granted to a consultant are fully vested
F- 18
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.