What changed in this filing

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Item 1. Financial Statements

2023-11-06 compared with 2023-08-07 · 239 added, 187 removed, 331 unchanged (56% of the section changed)

1 unchanged sentence

CONSOLIDATED FINANCIAL STATEMENTS

OF AND FOR THE QUARTER ENDED JUNE 30, 2023

CONDENSED CONSOLIDATED

FINANCIAL STATEMENTS:

OF AND FOR THE QUARTER ENDED SEPTEMBER 30, 2023

CONSOLIDATED FINANCIAL STATEMENTS:

Condensed Consolidated Balance Sheets

5 unchanged sentences

dollars in thousands)

September 30,

CURRENT ASSETS:

12 unchanged sentences

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, 2023 and December 31, 2022;

21,192,204 and 8,330,918 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively

Preferred C shares, par value $ 0.0001 per

1,172,000 shares

authorized at June 30, 2023 and December 31, 2022;

issued and outstanding at June 30, 2023 and December 31 2022, respectively

150,000,000 shares authorized at September 30, 2023 and December 31, 2022;

21,400,163 and 8,330,918 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively

Preferred C shares, par value $ 0.0001 per share;

1,172,000 shares authorized at September

30, 2023 and December 31, 2022;

1,718 shares issued and outstanding at September 30, 2023 and December 31 2022, respectively

Additional paid-in capital

7 unchanged sentences

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

NET LOSS PER SHARE - basic

WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING NET LOSS PER SHARE - basic and diluted

WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING NET LOSS PER SHARE - basic

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

5 unchanged sentences

Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 6,144 shares

BALANCE AT June 30, 2022

BALANCE AT September 30, 2022

* Represents an amount

5 unchanged sentences

Additional paid-in

BALANCE AT April 1, 2022

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

BALANCE AT June 30, 2022

BALANCE AT July 1, 2022

Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 1,581 shares

BALANCE AT September 30, 2022

* Represents an amount

3 unchanged sentences

dollars in thousands, except share data)

Series C Convertible Preferred Stock

Preferred Stock

Additional paid-in

2 unchanged sentences

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

BALANCE AT June 30, 2023

BALANCE AT September 30, 2023

* Represents an amount

3 unchanged sentences

dollars in thousands, except share data)

Series C Convertible Preferred Stock

Preferred Stock

Additional paid-in

BALANCE AT April 1, 2023

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

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

Share-based compensation related to stock, restricted stock,

restricted stock units and stock options award, net of forfeitures

BALANCE AT September 30, 2023

* Represents an amount

3 unchanged sentences

dollars in thousands)

Six months ended

Nine months ended

CASH FLOWS FROM OPERATING ACTIVITIES:

9 unchanged sentences

Changes in operating asset and liability items:

Decrease in prepaid expenses

Decrease (increase) in prepaid expenses

Decrease (increase) in trade receivables

1 unchanged sentence

Increase in inventory

Increase in trade payables

Decrease in trade payables

Increase (decrease) in other payables

11 unchanged sentences

Proceeds from issuance of shares and warrants net of $ 4,635 issuance costs,

Net cash provided by financing activities

Net cash provided by (used in) financing activities

EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS

4 unchanged sentences

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 consolidated financial statements.

1 unchanged sentence

1 - DESCRIPTION OF BUSINESS

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

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’s MGuard™

Prime™ embolic protection system (“MGuard Prime EPS”) was marketed for use in patients with acute coronary syndromes,

notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions, or bypass surgery.

EPS combines MicroNet with a bare-metal cobalt-chromium based stent.

MGuard Prime EPS received CE mark approval in the European Union

in October 2010 for improving luminal diameter and providing embolic protection.

Over the past years, there has been a shift in industry

preferences away from bare-metal stents, such as MGuard Prime EPS in ST-Elevation Myocardial Infarction (“STEMI”) patients.

As a result of declining sales of the MGuard Prime EPS, which the Company believes is largely driven by the predominant industry

preferences favoring drug-eluting, or drug-coated, stents, during the second quarter of 2022, the Company ceased sales of the Company’s

MGuard Prime EPS following a phase out period.

The Company markets its

products through distributors in international markets, mainly in Europe.

As of the date of issuance

of the 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.

Company’s carotid product (CGuard™ EPS) combines MicroNet and a self-expandable nitinol stent in a single device to treat

carotid artery disease.

Company’s MGuard™ Prime™ embolic protection system (“MGuard Prime EPS”) was marketed for use in patients

with acute coronary syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions,

or bypass surgery.

MGuard Prime EPS combines MicroNet with a bare-metal cobalt-chromium based stent.

MGuard Prime EPS received CE

mark approval in the European Union in October 2010 for improving luminal diameter and providing embolic protection.

Over the past

years, there has been a shift in industry preferences away from bare-metal stents, such as MGuard Prime EPS in ST-Elevation Myocardial

Infarction (“STEMI”) patients.

As a result of declining sales of the MGuard Prime EPS, which the Company believes is

largely driven by the predominant industry preferences favoring drug-eluting, or drug-coated, stents, during the second quarter of

2022, the Company ceased sales of the Company’s MGuard Prime EPS following a phase out period.

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

of the date of issuance of these 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.

to satisfy regulatory requirements of the new European Medical Device Regulation could prevent the Company from marketing CGuard

EPS in countries requiring the CE Mark.

the European Union nations, medical devices must obtain a CE mark before they may be placed on the market.

In order to obtain and

maintain the CE mark, the Company must Company with EU law on medical devices, which, until May 26, 2021 was governed by the MDD,

by presenting comprehensive technical files for the Company’s products demonstrating safety and efficacy of the product to

be placed on the market and passing initial and annual quality management system audit as per ISO 13485 standard by a European Notified

The company has obtained ISO 13485 quality system certification and CGuard EPS that the Company currently distribute into the

European Union, displays the required CE mark.

In order to maintain certification, the Company is required to pass an annual surveillance

audit conducted by Notified Body auditors.

The European Union replaced the MDD with the new MDR regulations.

The MDR entered into

force after a transitional period of three years and a one year extension of that transition period due to the COVID-19 pandemic

on May 26, 2021 and which changes several aspects of the regulatory framework in the European Union.

Manufacturers had the duration

of the transition period to update their technical documentation and processes to meet the new requirements in order to obtain a

In the Company’s specific case, the Company’s CE mark for CGuard EPS under the MDD expired on November 12, 2022,

and the Company is in the final stages of technical documentation review by the Notified Body auditor to meet the MDR requirements

for recertification.

In the meantime, on February 14, 2023, the Company received a derogation per Article 97 paragraph 1 of Regulation

2017/745 from the Agency for Medicines and Health Products (FAMHP) allowing the Company to continue marketing CGuard EPS in the EU

until August 15, 2023, subject to certain procedural requirements.

Subsequently, on March 20, 2023 Regulation (EU) 2023/607 was published

allowing the Company to continue marketing CGuard EPS in EU countries under the MDD directive until December 31, 2027.

of the foregoing, the Company may market and sell CGuard EPS in the EU and certain other jurisdictions subject to certain procedural

requirements while the Company’s MDR CE recertification is pending.

the European Union (“EU”) nations, medical devices must obtain a CE mark before they may be placed on the market.

order to obtain and maintain the CE mark, the Company must comply with EU law on medical devices, which, until May 26, 2021 was governed

by the Medical Device Directive 93/42/EEC (“MDD”), by presenting comprehensive technical files for the Company’s

products demonstrating safety and efficacy of the product to be placed on the market and passing initial and annual quality management

system audit as per ISO 13485 standard by a European Notified Body.

The Company has obtained ISO 13485 quality system certification

and CGuard EPS that the Company currently distribute into the European Union, displays the required CE mark.

In order to maintain

certification, the Company is required to pass an annual surveillance audit conducted by Notified Body auditors.

The European Union

replaced the MDD with the new European Medical Device Regulation (MDR 2017/745) (“MDR”) regulations.

The MDR entered

into force after a transitional period of three years and a one year extension of that transition period due to the COVID-19 pandemic

on May 26, 2021 and which changes several aspects of the regulatory framework in the EU.

Manufacturers had the duration of the transition

period to update their technical documentation and processes to meet the new requirements in order to obtain a CE Mark.

In the Company’s

specific case, the Company’s CE mark for CGuard EPS under the MDD expired on November 12, 2022, and the Company is in the final

stages of technical documentation review by the Notified Body auditor to meet the MDR requirements for recertification.

In the meantime,

on February 14, 2023, the Company received a derogation per Article 97 paragraph 1 of Regulation 2017/745 from the Agency for Medicines

and Health Products (FAMHP) allowing the Company to continue marketing CGuard EPS in the EU until August 15, 2023, subject to certain

procedural requirements.

Subsequently, on March 20, 2023 Regulation (EU) 2023/607 was published allowing the Company to continue

marketing CGuard EPS in EU countries under the MDD directive until December 31, 2027.

As a result of the foregoing, the Company may

market and sell CGuard EPS in the EU and certain other jurisdictions subject to certain procedural requirements while the Company’s

MDR CE recertification is pending.

Risks Related to Our Operations in Israel including the recent attack by Hamas and other terrorist organizations from the Gaza Strip

and Israel’s war against them.

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 the 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 thousands

of deaths and injuries, and Hamas additionally kidnapped many Israeli civilians and soldiers.

Following the attack, Israel’s

security cabinet declared war against Hamas and commenced a military campaign against Hamas and other terrorist organizations in

parallel to their continued rocket and terror attacks.

The Company cannot currently predict the intensity or duration of Israel’s

war against Hamas, nor can predict how this war will ultimately affect the Company’s business and operations or Israel’s

economy in general.

Risks Related to the Geopolitical and Military Tensions Between Russia and Ukraine in Europe

February 2022, Russia launched a military invasion into Ukraine.

The Company derived approximately 12.1% of total sales in Russia

and Belarus in 2022 while during the six and three months ended June 30, 2023, the Company’s sales to Russia and Belarus were

10.0% and 11.6%, compared to 6.8% and 10.9% in the six and three months ended June 30, 2022, respectively.

The escalation of geopolitical

instability in Russia and Ukraine as well as currency fluctuations in the Russian Ruble could negatively impact the Company’s

The Company derived approximately

12.1 % of total sales in Russia and Belarus in 2022 while during the nine and three months

ended September 30, 2023, the Company’s sales to Russia and Belarus were 13.1 % and

19.6 % ,respectively, compared to 11.9 % and 21.5 % in the nine and three months ended September

30, 2022, respectively.

The escalation of geopolitical instability in Russia and Ukraine

as well as currency fluctuations in the Russian Ruble could negatively impact the Company’s

operations, sales, and future growth prospects in that region.

1 unchanged sentence

entities and have made it more difficult for the Company to collect on outstanding accounts receivable from customers in this region.

The Company’s global operations expose the Company to risks that could adversely affect the Company’s business, financial

condition, results of operations, cash flows or the market price of the Company’s securities, including the potential for increased

tensions between the United States and Russia resulting from the current situation involving Russia and Ukraine, tariffs, economic

sanctions and import-export restrictions imposed by either nation, and retaliatory actions by the other nation, as well as the potential

negative impact on the Company’s business and sales in Russia and Belarus.

Current geopolitical instability in Russia and Ukraine

and related sanctions by the U.S.

government against certain companies and individuals may hinder the Company’s ability to

conduct business with potential or existing customers and vendors in these countries.

government has imposed sanctions through several executive orders restricting U.S.

companies from conducting business with specified

Russian individuals and companies.

While the Company believes that the executive orders currently do not preclude the Company from

conducting business with the Company’s current customers or vendors in Russia and Belarus, the sanctions imposed by the U.S.

government may be expanded in the future to restrict the Company from engaging with them.

If the Company is unable to conduct business

with new or existing customers or vendors or pursue business opportunities in Russia or Belarus, the Company’s business, including

revenue, profitability and cash flows, and operations could be adversely affected.

The Company cannot provide assurance that current

sanctions or potential future changes in sanctions will not have a material impact on the Company’s operations in Russia and

Belarus or on the Company’s financial results.

The Company cannot provide assurance that current sanctions or potential future changes in sanctions will not have a material

impact on the Company’s operations in Russia and Belarus or on the Company’s financial results.

2 - BASIS OF PRESENTATION

7 unchanged sentences

Commission on March 30, 2023.

The results of operations for the three and six months ended June 30, 2023, are not necessarily indicative

The results of operations for the three and nine months ended September 30, 2023, are not necessarily indicative

of results that could be expected for the entire fiscal year.

2 unchanged sentences

be cash equivalents.

As of June 30, 2023, cash and cash equivalents consisted of cash, short-term deposits (up to three months from the

date of deposit) and money market funds.

As of September 30, 2023, cash and cash equivalents consisted of cash, short-term deposits (up to three months from

the date of deposit) and money market funds.

As of December 31, 2022, this balance consisted solely of cash.

52 unchanged sentences

OF FINANCIAL ASSETS SUBJECT TO FAIR VALUE MEASUREMENTS

As of June 30, 2023

($ in thousands)

Cash equivalents-

Money market funds

Cash equivalents

Marketable securities-

U.S government bonds

Marketable securities

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, 2023 is $ 28,838 thousand.

of September 30, 2023

government bonds

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.

cost of marketable securities as of September 30, 2023 is $ 28,838 thousands.

5 - MARKETABLE SECURITIES

1 unchanged sentence

OF MARKETABLE SECURITIES

September 30,

($ in thousands)

1 unchanged sentence

Marketable securities

following table summarizes the fair value of the Company’s marketable securities classified by maturity as of June 30, 2023, and

December 31, 2022:

SCHEDULE OF FAIR VALUE OF

MARKETABLE SECURITIES CLASSIFIED BY MATURITY

following table summarizes the fair value of the Company’s marketable securities classified by maturity as of September 30, 2023,

and December 31, 2022:

OF FAIR VALUE OF MARKETABLE SECURITIES CLASSIFIED BY MATURITY

September 30,

($ in thousands)

1 unchanged sentence

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 six months period

ended June 30, 2023:

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, 2023:

OF CHANGES IN FAIR VALUE OF MARKETABLE SECURITIES

Six months ended

Nine months ended

September 30,

($ in thousands)

31 unchanged sentences

be exercised on a cashless basis if there is no effective registration statement registering the shares underlying the warrants.

of June 30, 2023, there are 15,561,894 outstanding Pre-Funded Warrants.

of September 30, 2023, there are 15,561,894 outstanding Pre-Funded Warrants.

to the full ratchet anti-dilution adjustment provisions in the respective certificate of designation for the Company’s Series C

3 unchanged sentences

C Preferred Stock, based on 1,718 shares of Series C Preferred Stock outstanding as of May 16, 2023.

of June 30, 2023, 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.

of June 30, 2023, the Company has outstanding warrants to purchase an aggregate of 53,449,832

of September 30, 2023, 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.

of September 30, 2023, the Company has outstanding warrants to purchase an aggregate of 53,396,008

shares of common stock as follows:

SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK

Exercise price

Series E Warrants

6 unchanged sentences

Underwriter Warrants

Other warrants

225 and above

Total Warrants

of June 30, 2023, 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, 2023, the Company granted 2,569,540 restricted shares of the

Company’s common stock to employees and directors.

The shares are subject to a three-year

vesting period, with one-third of such awards vesting each year.

of September 30, 2023, 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 nine months ended September 30, 2023, the Company granted 2,774,600 restricted shares

of the Company’s common stock to employees and directors.

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 shares was approximately $ 5.23 million.

the six months ended June 30, 2023, the Company granted 1,045,150 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, 2023, the Company granted 1,045,150 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.

fair value of the above restricted share units was approximately $ 1,839 thousand.

31 unchanged sentences

fair value of the above options, using the Black-Scholes option-pricing model, was approximately $ 885 thousand.

to Receive Shares of Common Stock in lieu of Cash Compensation

on January 1, 2023, non-employee directors may elect to receive all or a portion of their cash retainer amount in shares of the

Company’s common stock under the 2021 Equity Incentive Plan.

If a director makes that election, a stock award under the 2021

Equity Incentive Plan will be paid quarterly on the first day of each next quarter (“Issuance Dates”) and will become

fully vested on the Issuance Dates.

The stock award will be determined by dividing (x) the product of the cash retainer amount and

percentage of the cash retainer amount elected to be taken in shares by (y) the “Fair Market Value” (as defined in the

2021 Equity Incentive Plan) of a share on the Issuance Dates.

If a director’s service on the board terminates for any reasons

prior to an Issuance Date, he/she will receive a pro rata portion of shares or cash based on the number of days served on the board

during the relevant quarter.

On April 1, 2023, the Company issued 29,746

shares of common stock to non-employee directors who elected to receive all or a portion of their cash retainer amount for the three

months ended March 31, 2023 in shares of the Company’s common stock under the 2021 Equity Incentive Plan.

As of June 30, 2023,

there was an accrual for $ 55,000

for director’s fees for the three months ended June 30, 2023.

Out of this an amount of $ 22,875

will be paid in cash and $ 32,125

will be issued in shares of the Company’s common stock under the 2021 Equity Incentive Plan and accordingly on July 1, 2023

the Company issued 12,648

share of common stock.

August 28, 2023 and September 10, 2023the Company granted to employees options to purchase a total of 38,740 shares of the Company’s

common stock.

The options have an exercise prices of $ 3.37 -$ 3.57 per share, which was the fair market value of the Company’s common

stock on the date of the grant.

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

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 of 114.25 %- 123.07 %;

and risk-free interest rate of 4.34 %- 4.39 %.

fair value of the above options, using the Black-Scholes option-pricing model, was approximately $ 120,000 thousand.

Election to Receive

Shares of Common Stock in lieu of Cash Compensation

on January 1, 2023, non-employee directors may elect to receive all or a portion of their cash retainer amount in shares of the Company’s

common stock under the 2021 Equity Incentive Plan.

If a director makes that election, a stock award under the 2021 Equity Incentive Plan

will be paid quarterly on the first day of each next quarter (“Issuance Dates”) and will become fully vested on the Issuance

The stock award will be determined by dividing (x) the product of the cash retainer amount and percentage of the cash retainer

amount elected to be taken in shares by (y) the “Fair Market Value” (as defined in the 2021 Equity Incentive Plan) of a share

on the Issuance Dates.

If a director’s service on the board terminates for any reasons prior to an Issuance Date, he/she will receive

a pro rata portion of shares or cash based on the number of days served on the board during the relevant quarter.

April 1, 2023, the Company issued 29,746 shares of common stock to non-employee directors who elected to receive all or a portion of

their cash retainer amount for the three months ended March 31, 2023 in shares of the Company’s common stock under the 2021 Equity

Incentive Plan.

July 1, 2023, the Company issued 12,648 shares of common stock to non-employee directors who elected to receive all or a portion of their

cash retainer amount for the three months ended June 30, 2023 in shares of the Company’s common stock under the 2021 Equity Incentive

of September 30, 2023, there was an accrual for $ 55,000 for director’s fees for the three months ended September 30, 2023.

of this an amount of $ 22,875 will be paid in cash and $ 32,125 will be issued in shares of the Company’s common stock under the

2021 Equity Incentive Plan and accordingly On October 1, 2023 the company issued 9,735 shares.

7 – RELATED PARTIES TRANSACTIONS

the six and three months ended June 30, 2022, a consulting company whose founder and CEO is a member of the company’s board of

directors, provided certain marketing services in the amount of $ 8,776 and $ 2,500 , respectively.

During the six and three months ended

June 30, 2023, no marketing services were provided.

the nine and three months ended September 30, 2022, a consulting company whose founder and

CEO is a member of the company’s board of directors, provided certain marketing services

in the amount of $ 9,276 and $ 500 , respectively.

During the nine and three months ended September

30, 2023, no marketing services were provided.

September 15, 2023, the board approved the company’s entry into a consultancy agreement

with a member of the immediate family of the CEO for certain administrative projects in connection

with the Company’s expansion to the U.S.

until a full-time Company employee is retained

in such capacity.

Pursuant to the Consultancy Agreement, the Company will pay a fixed hourly

fee of $ 50 for a maximum of 20 hours per week and customary expenses.

The Company may terminate

this Agreement for any reason or no reason, at any time, upon 30 days prior written notice

to consultant.

expenses for the nine and three-month periods ended September 30, 2023, were $ 4,000 .

8 - NET LOSS PER SHARE :

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, fully vested pre-funded warrants and fully vested restricted stock units outstanding during the period.

The calculation of diluted

net loss per share excludes potential share issuances of common stock upon the exercise of share options, warrants, and unvested restricted

stocks, unvested restricted stock units and Series C preferred stock as the effect is anti-dilutive.

stock, pre-funded warrants and fully vested restricted stock units outstanding during the period.

The calculation of diluted net loss

per share excludes potential share issuances of common stock upon the exercise of share options, warrants, and unvested restricted stocks,

unvested restricted stock 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

1 unchanged sentence

260-10-45-13, and have no vesting or other contingencies associated with them.

For the six and three-month periods ended June 30, 2023,

we had weighted average Pre-funded Warrants of 3,954,956

and 7,866,452 ,

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

For the nine and three-month periods ended September 30,

2023, we had weighted average Pre-funded Warrants of 7,866,452 and 15,561,894 , 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 75,186,979 for the six and three-month

periods ended June 30, 2023.

This amount includes 2,905,615 of unvested restricted stock included in the number of issued and outstanding

shares as of June 30, 2023.

total number of shares of common stock related to outstanding options, warrants, restricted stock, restricted stock units and Series

C Preferred Stock excluded from the calculations of diluted loss per share were 3,010,707 for the six and three month periods ended June

This amount includes 547,792 of unvested restricted stock included in the number of issued and outstanding shares as of June

units and Series C Preferred Stock excluded from the calculations of diluted loss per share were 75,315,352 for the nine and three-month

periods ended September 30, 2023.

This amount includes 3,073,821 of unvested restricted stock included

in the number of issued and outstanding shares as of September 30, 2023.

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 2,932,284 for the nine and three month

periods ended September 30, 2022.

This amount includes 497,767 of unvested restricted stock included

in the number of issued and outstanding shares as of September 30, 2022.

9 – LEASE AGREEMENTS

Company’s Israeli subsidiary has a lease agreement for a facility in Israel, which

expires on December 31, 2026.

On August 24, 2023, the Company amended the lease agreement

mentioned above, leasing additional space in the facility and shortened the lease term of

another space in the building.

he balances of right of use assets and lease liabilities increased

due to the newly leased space and decreased due to the lease that was shortened.

lease cost for the nine and three-month periods ended September 30, 2023 were $ 337,000 and

$ 112,000 respectively

information related to leases are as follows:

SCHEDULE OF SUPPLEMENTAL INFORMATION RELATED TO LEASES

($ in thousands)

Operating lease right-of-use assets

Current operating lease liabilities

Non-current operating lease liabilities

Weighted Average Remaining Lease Term

Weighted Average Discount Rate

Nine months ended

September 30,

Twelve months ended

Operating cash flows from operating leases (cash paid in thousands)

of lease liabilities are as follows:

SCHEDULE OF MATURITIES OF LEASE LIABILITIES

($ in thousands)

Total lease payments

Less imputed interest

10 - FINANCIAL INSTRUMENTS :

2 unchanged sentences

to the relatively short-term maturities of such instruments.

of June 30, 2023, and December 31, 2022, allowance for expected credit loss was immaterial.

of September 30, 2023, and December 31, 2022, allowance for expected credit loss was immaterial.

11- INVENTORY :

OF INVENTORIES

September 30,

($ in thousands)

4 unchanged sentences

OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER

September 30,

($ in thousands)

11 unchanged sentences

Three months ended

Six months ended

September 30,

Nine months ended

September 30,

($ in thousands)

1 unchanged sentence

Three months ended

Six months ended

September 30,

Nine months ended

September 30,

($ in thousands)

2 unchanged sentences

Three months ended

Six months ended

September 30,

Nine months ended

September 30,

tangible long lived assets are located in Israel.

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