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Item 1. Financial Statements

2024-11-12 compared with 2024-08-05 · 224 added, 159 removed, 257 unchanged (60% of the section changed)

1 unchanged sentence

CONSOLIDATED FINANCIAL STATEMENTS

OF AND FOR THE QUARTER ENDED JUNE 30, 2024

OF AND FOR THE QUARTER ENDED SEPTEMBER 30, 2024

CONSOLIDATED FINANCIAL STATEMENTS:

6 unchanged sentences

dollars in thousands)

September 30,

CURRENT ASSETS:

7 unchanged sentences

Operating lease right of use assets

Funds in respect of employee rights upon retirement

Fund in respect of employee rights upon retirement

TOTAL NON-CURRENT ASSETS

1 unchanged sentence

dollars in thousands other than share and per share data)

September 30,

LIABILITIES AND EQUITY

9 unchanged sentences

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

150,000,000 shares authorized at September 30, 2024 and December 31, 2023;

25,719,632 and 21,841,215 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively

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

1,172,000 shares authorized at September 30, 2024 and December 31, 2023;

1,718 shares issued and outstanding at September 30, 2024 and December 31 2023, respectively

Additional paid-in capital

3 unchanged sentences

less than $1 thousand

accompanying notes are an integral part of the consolidated financial statements.

accompanying notes are an integral part of the condensed consolidated financial statements.

CONSOLIDATED STATEMENTS OF OPERATIONS

1 unchanged sentence

Three months ended

Six months ended

September 30,

Nine months ended

September 30,

COST OF REVENUES

7 unchanged sentences

NET LOSS PER SHARE - basic and diluted

WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING NET LOSS

PER SHARE - basic and diluted

accompanying notes are an integral part of the consolidated financial statements.

WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN

COMPUTING NET LOSS PER SHARE - basic

accompanying notes are an integral part of the condensed consolidated financial statements.

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

4 unchanged sentences

Issuance of common shares, pre-funded warrants and warrants, net of $ 4,635 issuance costs

Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 4,270 shares

BALANCE AT June 30, 2023

Issuance of common shares, pre-funded warrants and warrants,

net of issuance costs

Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures of 14,019 shares

BALANCE AT September 30, 2023

* Represents an amount

less than $1 thousand

accompanying notes are an integral part of the consolidated financial statements.

accompanying notes are an integral part of the condensed consolidated financial statements.

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

2 unchanged sentences

Additional paid-in

BALANCE AT April 1, 2023

Issuance of common shares, pre-funded warrants and warrants, net of $ 4,635 issuance costs

Issuance of common shares, pre-funded warrants and warrants,

net of issuance costs

Share-based compensation related to stock, restricted stock, restricted stock units and stock options award

BALANCE AT June 30, 2023

BALANCE AT July 1, 2023

Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures of 9,749 shares

BALANCE AT September 30, 2023

* Represents an amount

less than $1 thousand

accompanying notes are an integral part of the consolidated financial statements.

accompanying notes are an integral part of the condensed consolidated financial statements.

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

4 unchanged sentences

Exercise of pre-funded warrants

Exercise of Warrants Series H to 12,621,090 pre-funded warrants

and 292,996 common stock, net of $ 1,000

Exercise of Warrants Series H to 12,621,090 pre-funded warrants and 292,996 common stock, net of $ 1,000 issuance costs

Exercise of Warrants Series H to pre-funded warrants and common

stock, net of issuance

Issuance of common shares, Included at the market offering net

issuance costs

Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures of 112,382 shares

BALANCE AT June 30, 2024

BALANCE AT September 30, 2024

* Represents an amount

less than $1 thousand

accompanying notes are an integral part of the consolidated financial statements.

accompanying notes are an integral part of the condensed consolidated financial statements.

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

2 unchanged sentences

Additional paid-in

BALANCE AT April 1, 2024

BALANCE AT July 1, 2024

Exercise of pre-funded warrants

Exercise of Warrants Series H to 12,621,090 pre-funded warrants

and 292,996 common stock, net of $ 1,000

issuance costs

Exercise of Warrants Series H to pre-funded warrants and common

stock, net of issuance costs

Share-based compensation related to stock, restricted stock, restricted stock units and stock options award, net of forfeitures of 37,292 shares

Share-based compensation related to stock,

restricted stock, restricted stock units and stock options award, net of forfeitures

BALANCE AT June 30, 2024

Issuance of common shares, Included at the market offering net of $ 1 issuance costs

Issuance of common shares, including at the market offering

Share-based compensation related to stock, restricted stock, restricted stock units and stock options award

BALANCE AT September 30, 2024

* Represents an amount

less than $1 thousand

accompanying notes are an integral part of the consolidated financial statements.

accompanying notes are an integral part of the condensed consolidated financial statements.

CONSOLIDATED STATEMENTS OF CASH FLOWS

dollars in thousands)

Six months ended

Nine months ended

CASH FLOWS FROM OPERATING ACTIVITIES:

4 unchanged sentences

Change in liability for employees’ rights upon retirement

Other financial expenses

Other financial expenses (income)

Change in operating right of use asset and leasing liability

4 unchanged sentences

Decrease (increase) in trade receivables

Decrease (increase) in other receivables

Increase in other receivables

Increase in inventory

Increase (decrease) in trade payables

Decrease in other payables

Increase (decrease) in other payables

Net cash used in operating activities

9 unchanged sentences

CASH FLOWS FROM FINANCING ACTIVITIES:

Proceeds from exercise of warrants

Proceeds from exercise of warrants, net of $ 1,000 issuance costs

Proceeds from issuance of shares and warrants, net

1 unchanged sentence

EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS

INCREASE IN CASH AND CASH EQUIVALENTS

INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD

1 unchanged sentence

SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES:

Issuance Costs not yet paid

accompanying notes are an integral part of the consolidated financial statements.

Acquisition of right-of-use assets by means of lease liabilities

Non-cash lease incentive

Decrease in right-of-use assets and lease liabilities due to shortening lease term

accompanying notes are an integral part of the condensed consolidated financial statements.

TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

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Company markets its products through distributors in international markets, mainly in Europe.

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

War against Hamas

Company has an accumulated deficit as of September 30, 2024, as well as a history of net losses and negative operating cash flows

in recent years.

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

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.

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.

Related to the Company’s Operations in Israel

October 2023, Israel was attacked by a terrorist organization and entered a state of war.

1 unchanged sentence

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.

organization), Israel’s southern border with the Gaza Strip (with the Hamas terrorist organization) and on other fronts from

various extremist groups in region, such as the Houthis in Yemen and various rebel militia groups in Syria and Iraq.

Iran recently launched direct attacks 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.

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.

Currently, such activities in Israel remain largely

the nine and three months ended September 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

2 - BASIS OF PRESENTATION

4 unchanged sentences

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.

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.

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

nine months ended September 30, 2024, are not necessarily indicative of results that could be expected for the entire fiscal

3 - RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS

2 unchanged sentences

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

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.

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

The Company adopted the provisions of this update as of January 1, 2024 with no material impact on its consolidated financial

issued accounting pronouncement, not yet adopted

1 unchanged sentence

Improvements to Reportable Segment Disclosures”.

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

The amendments are required to be applied retrospectively to all prior periods presented in an entity’s financial

The Company is currently evaluating this guidance to determine the impact it may have on its condensed consolidated

financial statements related disclosures.

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

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.

is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements related disclosures.

December 2023, the FASB issued ASU 2023-09 “Income Taxes (Topic 740):

2 unchanged sentences

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.

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.

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.

The Company is currently

evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.

4 – FAIR VALUE MEASUREMENTS

13 unchanged sentences

OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS

As of June 30, 2024

As of September 30, 2024

Cash equivalents-

1 unchanged sentence

Marketable securities-

U.S government bonds

government bonds

As of December 31, 2023

4 unchanged sentences

Marketable securities-

U.S government bonds

government bonds

Marketable securities

1 unchanged sentence

models utilizing market observable inputs to determine their fair value.

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

cost of marketable securities as of September 30, 2024, is $ 23,919 thousand.

cost of Marketable securities as of December 31, 2023 is $ 28,727 thousand.

5 - MARKETABLE SECURITIES

following table sets forth the Company’s marketable securities for the indicated periods:

following table sets forth the Company’s marketable securities for the indicated period:

OF MARKETABLE SECURITIES

September 30,

($ in thousands)

U.S government bonds

government bonds

Marketable securities

following table summarizes the fair value of the Company’s marketable securities classified by maturity as of June 30, 2024, and

December 31, 2023:

following table summarizes the fair value of the Company’s marketable securities classified by maturity as of September 30, 2024,

and December 31, 2023:

OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY

September 30,

($ in thousands)

maturing within one year

maturing after one year through two years

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:

Amounts maturing within one year

Amounts maturing after one year through two years

table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the nine months period

ended September 30, 2024:

OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES

Six months ended June 30,

Nine months ended

September 30,

Nine months ended September 30,

($ in thousands)

3 unchanged sentences

Balance at end of the period

Company elected the fair value option to measure and recognize its investments in debt securities in accordance with ASC 825, Financial

Instruments as the Company manages its portfolio and evaluates the performance on a fair value basis.

of Series H Warrant

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

Series H Warrants have a term of the earlier of (i) five years from the date of issuance and (ii) (A) 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

9 unchanged sentences

per pre-funded warrant, were issued as part of the private placement financing that the Company consummated on May 15, 2023.

of June 30, 2024, there are 26,347,323 outstanding pre-funded warrants.

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 .

of June 30, 2024, the Company has outstanding warrants to purchase an aggregate of 40,479,588 shares of common stock as follows:

Company maintains an at-the-market (“ATM”) facility with Piper Sandler & Co.

(“Piper”) pursuant to an Equity

Distribution Agreement entered into in May 2024.

In accordance with the agreement, the Company is entitled, at its sole discretion, to

offer and sell through or to Piper Sandler, acting as a sales agent, shares of its common stock having an aggregate offering price of

up to $ 17.0 million throughout the period during which the ATM facility remains in effect.

The Company has agreed to pay Piper a commission

of 3.0 % of the gross proceeds from the sale of shares of common stock under the ATM facility.

As of nine months ended September 30, 2024,

12,961 shares of common stock have been sold under the ATM program for total gross proceeds of approximately $ 35 thousand and total

fees of approximately $ 1 thousand.

the nine months ended September 30, 2024, the Company issued a total of 1,728,382 shares

of its common stock in connection with the exercise of Pre-Funded Warrants to purchase 1,728,390

shares of common stock of which 200,000 Pre-Funded were exercised to 199,992 shares of its

common stock on a cashless basis.

As of September 30, 2024, there are Pre-Funded Warrants

to purchase an aggregate of 26,147,323 shares of common stock outstanding.

of September 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 .

of September 30, 2024, the Company has outstanding warrants to purchase an aggregate of 40,268,464

shares of common stock as follows:

SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK

1 unchanged sentence

Expiration date

Series E Warrants

September 24, 2024

Series F Warrants

5 unchanged sentences

Series K Warrants

Underwriter Warrants

September 24, 2024

Total Warrants

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.

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.

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.

Warrants have a term of the earlier of (i) May 15, 2028 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.

the nine months ended September 30, 2024, a total of 213,458 warrants expired.

of September 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.

September 30, 2024, the compensation committee of the Company’s board of directors of approved the InspireMD, Inc.

2024 Inducement

Plan (the “2024 Inducement Plan”) to be

used exclusively for grants of equity-based awards to individuals who were not previously employees or directors of the Company, as an

inducement material to the individual’s entry into employment with the Company.

the nine months ended September 30, 2024, the Company granted 1,944,603 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.

fair value of the above restricted shares was approximately $ 5.83 million.

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 nine months ended September 30, 2024, the Company granted 563,499 restricted share units

of the Company’s common stock to the chief executive officer (CEO).

The shares are

subject to a three-year vesting period, with one-third of such awards vesting each year.

fair value of the above restricted share units was approximately $ 1.77 million.

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 nine months ended September 30, 2024, the Company granted to employees and directors

options to purchase a total of 761,114 shares of the Company’s common stock.

have exercise prices ranging from $ 2.44 -$ 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

The options to directors are subject to a one-year vesting period.

5 unchanged sentences

fair value of the above options, using the Black-Scholes option-pricing model, was approximately $ 1.94 million.

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.

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

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.

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;

dividend yield of 0 %;

expected volatility ranging from 96.01 %- 100.76 %;

2 unchanged sentences

7 – RELATED PARTIES TRANSACTIONS

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.

the nine and three months ended September 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 $ 55,000 and

respectively.

8 - NET LOSS PER SHARE :

4 unchanged sentences

units and Series C preferred stock as the effect is anti-dilutive.

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 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.

For the nine and three-month periods

ended September 30, 2024, we had weighted average pre-funded warrants of 19,016,286

and 26,199,497 ,

respectively, which were used in the computations of net loss per share for the nine and three-month periods.

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.

units and Series C Preferred Stock excluded from the calculations of diluted loss per share were 48,619,222 and 59,753,458 as of September 30, 2024 and 2023, respectively.

This amount includes 3,979,486

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.

and 3,073,821 of unvested restricted stock included in the number of issued and outstanding shares as of September 30, 2024 and 2023,

respectively.

9 - FINANCIAL INSTRUMENTS :

Fair value of financial instruments

value of financial instruments

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.

As of June 30, 2024, and December 31, 2023, allowance for expected

credit loss was immaterial.

of September 30, 2024, and December 31, 2023, allowance for expected credit loss was immaterial.

10- INVENTORY :

OF INVENTORIES

September 30,

($ in thousands)

4 unchanged sentences

OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER

September 30,

($ in thousands)

2 unchanged sentences

Accrued expenses

Issuance costs not yet paid

Clinical trial accrual

Clinical trials accrual

Current Operating lease liabilities

5 unchanged sentences

SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS

Three months ended

September 30,

Nine months ended

September 30,

($ in thousands)

No single country included in other generated more than 10%

of total revenue

principal customers:

OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS

substantially tangible long lived assets are located in Israel.

Three months ended

September 30,

Nine months ended

September 30,

13 – SUBSEQUENT EVENTS

As of the approval date of these financial statements, the Company has issued an aggregate of 197,167 shares

of restricted common stock pursuant to the 2024 Inducement Plan and 32,648

shares of restricted common stock under the 2021 plan.

October 9, 2024, the Company entered into a lease agreement in Miami, Florida (the “Lease”)

for the establishment of its new global headquarters.

The Lease has a term of 64 months from

the Commencement Date (as defined in the Lease) subject to a five -year extension in accordance

with the terms of the Lease.

the Lease, the Company will pay the Landlord a security deposit of $ 500 thousand.

Provided the Company does not default, the security

deposit will be refunded at specified intervals throughout the lease term.

Additionally, the Company will pay a base rent of $ 23 thousand per month for the first year, with gradual annual increases each subsequent year.

The Company is also responsible for covering standard

lease expenses, including applicable taxes, operating expenses, and utilities.

October 1, 2024 through the date of the approval of these financial statements, 134,316 shares of common stock have been sold under

the ATM program for total gross proceeds of approximately $ 341 thousands and total fees of approximately $ 10 thousands.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements