QTREX Quantum Ltd 20-F/A for FY2022
QTREX Quantum Ltd. (QTEX)
About this 20-F/A
QTREX Quantum Ltd filed this 20-F/A on April 20, 2023, covering the fiscal year ended December 31, 2022 (FY2022).
Headline figures
Fiscal year ended December 31, 2022, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Net income
- $10.3M
- down 39.1% from net income of $16.9M a year earlier
- Diluted EPS
- -$0.95
- compared with -$3.20 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
(Amendment No. 1)
OR
For the fiscal year ended
OR
OR
Commission File No.:
(Exact name of registrant as specified in its charter)
Translation of registrant’s name into English: Not applicable
State of
(Jurisdiction of incorporation or organization)
Tel: +
(Address of principal executive offices)
Tel: +972.4.6230333
(Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person)
Securities registered or to be registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| Warrant to purchase one Ordinary Share | IINNW |
Securities registered or to be registered pursuant to Section 12(g) of the Act: None
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by the annual report:
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes ☐
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act of 1934.
Yes ☐
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Yes ☐
Indicate by check mark whether the registrant has submitted every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months.
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” and emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer ☐ | Accelerated filer ☐ | |
| Emerging Growth Company |
If an emerging growth company that prepares its
financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition
period for complying with any new or revised financial accounting standards† provided pursuant to Section 13(a) of the Exchange
Act.
†The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.
Yes ☐ No
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing.
U.S. GAAP ☐
International Financial Reporting Standards as issued by the ☒
Other ☐
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.
☐ Item 17 ☐ Item 18
If this is an annual report, indicate by check mark whether the registrant is a shell company.
Yes ☐ No
EXPLANATORY NOTE
We are filing this Amendment No. 1 (this “Amendment”) to our Annual Report on Form 20-F (the “Original Filing”) for the sole purpose of amending Item 18 of the Original Filing to amend the date of the auditor’s opinion located on page F-2 of this Amendment. For clarity, the audited consolidated financial statements as of and for the fiscal years ended December 31, 2022, 2021, and 2020 included in this Amendment No. 1 are unchanged from the audited consolidated financial statements included in the Original Filing.
In addition, pursuant to Rule 12b-15 under the Securities Exchange Act of 1934, as amended, the certifications pursuant to Section 302 and Section 906 of the Sarbanes-Oxley Act of 2002 have been re-executed as of the date of, and are re-filed as part of, this Amendment No. 1 as Exhibits 12.1, 12.2, 13.1 and 13.2.
Other than expressly set forth herein, this Amendment No. 1 does not, and does not purport to, amend or restate any other information contained in the Original Filing nor does this Amendment No. 1 reflect any events that have occurred after the Original Filing was filed.
i
TABLE OF CONTENTS
| Page | ||
| EXPLANATORY NOTE | i | |
| PART III | ||
| ITEM 17. | FINANCIAL STATEMENTS | 1 |
| ITEM 18. | FINANCIAL STATEMENTS | 1 |
| ITEM 19. | EXHIBITS. | 1 |
| SIGNATURES | 2 | |
ii
PART III
ITEM 17. FINANCIAL STATEMENTS
We have elected to provide financial statements and related information pursuant to Item 18.
ITEM 18. FINANCIAL STATEMENTS
The consolidated financial statements and the related notes required by this Item are included in this Amendment No. 1 to our annual report on Form 20-F beginning on page F-1.
ITEM 19. EXHIBITS.
| * | Filed herewith. |
| % | Furnished herewith |
1
SIGNATURES
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized the undersigned to sign this annual report on Form 20-F filed on its behalf.
| INSPIRA TECHNOLOGIES OXY B.H.N. LTD. | ||
| Date: April 19, 2023 | By: | /s/ Dagi Ben-Noon |
| Dagi Ben-Noon | ||
| Chief Executive Officer | ||
2
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
TABLE OF CONTENTS
______________________
________________
____________
The amounts are stated in thousands of U.S. dollars
F-1
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To The Board of Directors and Shareholders of Inspira Technologies Oxy B.H.N. Ltd.
Ha-Tidhar Street 2, Rananna, Israel
Opinion on the Financial Statements
We have audited the accompanying statements of financial position of Inspira Technologies Oxy B.H.N. Ltd. (formerly: Insense Medical Ltd.) (the “Company”) as of December 31, 2022 and 2021, the related statements of comprehensive loss, changes in shareholders’ equity, and cash flows for each of the three years in the period ended December 31, 2022, and the related notes (collectively, the “Financial Statements”). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2022, in conformity with International Financial Reporting Standards as issued by the International Accounting Standards Board.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
| Tel-Aviv, Israel | /s/ Ziv Haft |
| March 28, 2023 | Certified Public Accountants (Isr.) |
| We have served as the Company’s auditor since 2018. | BDO Member Firm /s/ |
F-2
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
STATEMENTS OF FINANCIAL POSITION
(US dollars in thousands)
| December 31, | December 31, | |||||||||||
| Note | 2022 | 2021 | ||||||||||
| ASSETS | ||||||||||||
| Current Assets | ||||||||||||
| Cash and cash equivalents | ||||||||||||
| Deposits | 4 | |||||||||||
| Other current assets | 5 | |||||||||||
| Total current assets | ||||||||||||
| Non-Current Assets: | ||||||||||||
| Right of use assets, net | 16 | |||||||||||
| Property, plant and equipment, net | 6 | |||||||||||
| Total non-current assets | ||||||||||||
| Total Assets | ||||||||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||||||
| Current Liabilities: | ||||||||||||
| Trade accounts payables | ||||||||||||
| Other accounts payables | 7 | |||||||||||
| Lease liabilities | 16 | |||||||||||
| Financial liabilities at fair value | 9 | |||||||||||
| Total current liabilities | ||||||||||||
| Non-Current Liabilities: | ||||||||||||
| Lease liabilities | 16 | |||||||||||
| Loan from the Israeli Innovation Authority | 8 | |||||||||||
| Total non- current liabilities | ||||||||||||
| Shareholders’ Equity: | ||||||||||||
| Share capital and additional paid in capital | 10 | |||||||||||
| Foreign exchange reserve | ( | ) | ||||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||||||
| Total Shareholders’ Equity | ||||||||||||
| Total liabilities and Shareholders’ Equity | ||||||||||||
| /s/ Yafit Tehila | /s/ Dagi Ben-Noon | March 28, 2023 | ||
Yafit Tehila |
Dagi Ben-Noon |
Date of approval of financial statements |
The accompanying notes are an integral part of the financial statements.
F-3
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
STATEMENTS OF COMPREHENSIVE LOSS
(US dollars in thousands except for loss per share)
| Year ended December 31, | ||||||||||||||||
| Note | 2022 | 2021 | 2020 | |||||||||||||
| Research and development expenses | 11 | |||||||||||||||
| Sales and marketing expenses | 12 | |||||||||||||||
| General and administrative expenses | 13 | |||||||||||||||
| Other income | ||||||||||||||||
| Operating loss | ||||||||||||||||
| Finance expense | 14 | |||||||||||||||
| Finance income | 14 | ( | ) | ( | ) | |||||||||||
| Loss before tax | ||||||||||||||||
| Taxes on income | ||||||||||||||||
| Total net loss | ||||||||||||||||
| Other comprehensive loss, net of tax: | ||||||||||||||||
| Items that will not be reclassified to profit or loss: | ||||||||||||||||
| Exchange (losses)profits arising on translation to presentation currency | ( | ) | ( | ) | ||||||||||||
| Total comprehensive loss | ||||||||||||||||
| Weighted average number of ordinary shares | ||||||||||||||||
| ( | ) | ( | ) | ( | ) | |||||||||||
The accompanying notes are an integral part of the financial statements.
F-4
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
(US dollars in thousands)
For the year ended December 31, 2022:
| Ordinary Share Capital | ||||||||||||||||||||
| Number of shares | Share capital and Additional Paid in Capital | Adjustments arising from translating financial operation | Accumulated deficit | Total | ||||||||||||||||
| Balance as of January 1, 2022: | ( | ) | ||||||||||||||||||
| Changes during the period: | ||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||
| Other comprehensive loss | - | ( | ) | ( | ) | |||||||||||||||
| Total comprehensive loss | ( | ) | ( | ) | ( | ) | ||||||||||||||
| Share based compensation to exercise | ||||||||||||||||||||
| RSUs vesting | ||||||||||||||||||||
| Share based compensation | - | - | - | |||||||||||||||||
| Balance as of December 31, 2022 | ( | ) | ( | ) | ||||||||||||||||
| (*) |
The accompanying notes are an integral part of the financial statements.
F-5
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
(US dollars in thousands)
For the year ended December 31, 2021:
| Ordinary Share Capital | Additional | Adjustments arising from translating | ||||||||||||||||||||||
| Number of shares | Share capital | Paid in Capital | financial operation | Accumulated deficit | Total | |||||||||||||||||||
| Balance as of January 1, 2021: | ( | ) | ( | ) | ( | ) | ||||||||||||||||||
| Changes during the period: | ||||||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||||||
| Other comprehensive loss | - | |||||||||||||||||||||||
| Total comprehensive loss | ( | ) | ( | ) | ||||||||||||||||||||
| Par value cancellation | - | ( | ) | |||||||||||||||||||||
| Initial Public Offering (“IPO”) | ||||||||||||||||||||||||
| Conversion of financial liability | ||||||||||||||||||||||||
| Tradable warrants exercise | ||||||||||||||||||||||||
| RSUs vesting | ||||||||||||||||||||||||
| Share based compensation to exercise | ||||||||||||||||||||||||
| Share based compensation | - | |||||||||||||||||||||||
| Balance as of December 31, 2021 | - | ( | ) | |||||||||||||||||||||
| (*) | Less than thousand dollars |
The accompanying notes are an integral part of the financial statements.
F-6
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY
(US dollars in thousands)
For the year ended December 31, 2020:
| Ordinary Share Capital | Additional | Adjustments arising from translating | ||||||||||||||||||||||
| Number of shares | Share capital | Paid in Capital | financial operation | Accumulated deficit | Total | |||||||||||||||||||
| Balance as of January 1, 2020: | ( | ) | ( | ) | ( | ) | ||||||||||||||||||
| Changes during the period: | ||||||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||||||
| Other comprehensive loss | - | ( | ) | ( | ) | |||||||||||||||||||
| Total comprehensive loss | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||
| Share split | - | ( | ) | |||||||||||||||||||||
| Share based compensation | - | |||||||||||||||||||||||
| Share based compensation to exercise | - | ( | ) | |||||||||||||||||||||
| Conversion of convertible loan to shares | ||||||||||||||||||||||||
| Balance as of December 31, 2020 | ( | ) | ( | ) | ( | ) | ||||||||||||||||||
The accompanying notes are an integral part of the financial statements.
F-7
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
STATEMENTS OF CASH FLOW
(US dollars in thousands)
| Year ended December 31 | ||||||||||||
| 2022 | 2021 | 2020 | ||||||||||
| CASH FLOW FROM OPERATING ACTIVITIES: | ||||||||||||
| Net loss | ( | ) | ( | ) | ( | ) | ||||||
| Adjustments to reconcile net loss to net cash provided by operating activities: | ||||||||||||
| Depreciation | ||||||||||||
| Exercise of warrants | ||||||||||||
| Share based compensation | ||||||||||||
| Revaluation of financial liabilities accounted at fair value | ( | ) | ||||||||||
| Changes of financial liabilities - IPO non-cash expenses | ||||||||||||
| Change in connection to loan from the Israeli Innovation Authority | ( | ) | ||||||||||
| Financial expenses | ( | ) | ||||||||||
| Changes in operating assets and liability | ||||||||||||
| Decrease (increase) in other current assets | ( | ) | ||||||||||
| Increase (decrease) in trade accounts payables | ( | ) | ||||||||||
| Increase in other accounts payable | ||||||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ( | ) | ||||||
| CASH FLOW FROM INVESTING ACTIVITIES: | ||||||||||||
| Purchase of property, plant, and equipment | ( | ) | ( | ) | ( | ) | ||||||
| Payment of deposit | ( | ) | ( | ) | ||||||||
| Change of deposit | ( | ) | ||||||||||
| Net cash used in investing activities | ( | ) | ( | ) | ( | ) | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||||||
| Principal paid on lease liabilities | ( | ) | ( | ) | ( | ) | ||||||
| Receipt of simple agreements for future equity (SAFE) and convertible loan | ||||||||||||
| Receipt of IPO funds | ||||||||||||
| Receipt of warrants exercise funds, net from fees | ||||||||||||
| Loan from the Israeli Innovation Authority | ||||||||||||
| Net cash provided by (used in) financing activities | ( | ) | ||||||||||
| Net increase (decrease) in cash and cash equivalents | ( | ) | ||||||||||
| Cash and cash equivalents at the beginning of the period | ||||||||||||
| Effects of exchange rate changes on cash and cash equivalents | ( | ) | ||||||||||
| Cash and cash equivalents at the end of the period | ||||||||||||
The accompanying notes are an integral part of the financial statements
F-8
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
STATEMENTS OF CASH FLOW
(US dollars in thousands)
APPENDIX A – NON-CASH TRANSACTIONS:
| Year ended December 31, | ||||||||||||
| 2022 | 2021 | 2020 | ||||||||||
| Conversion of convertible loans to equity | ||||||||||||
| Tradable warrants at the IPO date | ( | ) | ||||||||||
| Tradable warrants financial liability at the IPO date | ( | ) | ||||||||||
| Share based compensation – underwriters fees at the IPO date | ||||||||||||
| Warrants exercise to equity – financial liability | ||||||||||||
| Warrants exercise – allocation from liability to equity | ||||||||||||
APPENDIX B - AMOUNT PAID DURING THE PERIOD:
| Year ended December 31, | ||||||||||||
| 2022 | 2021 | 2020 | ||||||||||
| Interest paid | ||||||||||||
The accompanying notes are an integral part of the financial statements
F-9
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 1 - GENERAL:
| 1. | Inspira Technologies Oxy B.H.N. Ltd (formerly: Insense Medical Ltd.) (the “Company”) was incorporated in Israel and commenced its operations on February 27, 2018. The Company’s functional currency is the New Israeli Shekel (“NIS”). |
The Company operates in the medical technology industry in the field of respiratory support technology engaged in the research, development, manufacturing related activities, and go to market activities of proprietary products and technologies. The Company is developing the following products:
(*)The INSPIRA ART (Augmented Respiratory Technology), which is a respiratory support technology targeted toward utilizing direct blood oxygenation to boost patient saturation levels within minutes while the patient is awake and spontaneously breathing. The aim is to reduce the need for invasive mechanical ventilation, with the potential to reduce risks, complications and high costs.
(*) The HYLA blood sensor, which is a non-invasive optical blood sensor designed to perform real-time and continuous blood measurements, potentially minimizing the need to take actual blood samples from patients.
(*)The ALICE Device, an advanced form of life support system better known by the medical industry as a cardiopulmonary bypass system is being designed for use in surgical procedures requiring cardiopulmonary bypass for six hours or less.
| 2. | The Company’s products are in the development stage. The ALICE device and the INSPIRA ART has not yet been tested or used in humans and the Company’s products have not been approved by the U.S. Food and Drug Administration (the “FDA”). |
| 3. | On July 16, 2021, the Company completed its IPO on the Nasdaq Capital Market, whereby the Company sold |
In October 2021, investors exercised
| 4. | The Company has not generated any revenue since its inception and the Company’s products are in the development stage. The Company’s operating loss for the years ended December 31, 2021 and 2022 were $ |
The Company’s management intends to seek additional funding through public offerings, which will be utilized to fund product development and continue operations. The Company does not have any material financial obligations as of the balance date. The Company believes that it has sufficient resources to operate in the foreseeable future.
| 5. | The Ukraine Conflict |
Although we do not currently conduct business in Russia and Ukraine, the escalation of geopolitical instability in Russia and Ukraine as well as currency fluctuations in the Russian Ruble has had a negative impact on worldwide markets. Such impact may negatively impact our supply chain, our operations and future growth prospects in that region. As a result of the crisis in Ukraine, both the U.S. and other countries have implemented sanctions against certain Russian individuals and entities. Our global operations expose us to risks that could adversely affect our business, financial condition, results of operations, cash flows or the market price of our securities, including the potential for increased tensions between Russia and other countries resulting from the current situation involving Russia and Ukraine, tariffs, economic sanctions and import-export restrictions imposed, and retaliatory actions, as well as the potential negative impact on our potential business and sales in the region. Current geopolitical instability in Russia and Ukraine and related sanctions by the U.S. and other governments against certain companies and individuals may hinder our ability to conduct business with potential customers and vendors in these countries.
| 6. | These financial statements were authorized by the board of directors on March 28, 2023. |
F-10
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES:
New standards, interpretations and amendments not yet effective.
There are a number of standards, amendments to standards, and interpretations which have been issued by the IASB that are effective in future accounting periods that the Company has decided not to adopt early.
In January 2020, the IASB issued amendments to IAS 1, which clarify the criteria used to determine whether liabilities are classified as current or non-current. These amendments clarify that current or non-current classification is based on whether an entity has a right at the end of the reporting period to defer settlement of the liability for at least twelve months after the reporting period. The amendments also clarify that ’settlement’ includes the transfer of cash, goods, services, or equity instruments unless the obligation to transfer equity instruments arises from a conversion feature classified as an equity instrument separately from the liability component of a compound financial instrument. The amendments were originally effective for annual reporting periods beginning on or after 1 January 2022. However, in May 2020, the effective date was deferred to annual reporting periods beginning on or after 1 January 2023.
In its June 2021 meeting, the IASB tentatively decided to amend the requirements of IAS 1 with respect to the classification of liabilities subject to conditions and disclosure of information about such conditions and to defer the effective date of the 2020 amendment by at least one year.
The Company is currently assessing the impact of these new accounting standards and amendments. The Company will assess the impact of the final amendments to IAS 1 on classification of its liabilities once the those are issued by the IASB.
The Company does not believe that the amendments to IAS 1, in its present form, will have a significant impact on the classification of its liabilities.
The Company does not expect any other standards issued by the IASB, but not yet effective, to have a material impact on the Company.
Basis of preparation
Use of estimates and assumptions in the preparation of the financial statements
The preparation of financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the dates of the financial statements and the reported amounts of expenses during the reporting periods. Actual results could differ from those estimates. See also Note 3.
Cash and cash equivalents
Cash equivalents are considered by the Company to be highly-liquid investments, including, short-term deposits with banks, the maturity of which does not exceed three months at the time of deposit and which are not restricted.
F-11
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (CONT.):
Loss per share
Basic and diluted loss per share is calculated as net loss attributed to the Company, divided by the weighted average number of ordinary shares, adjusted for any bonus element.
Diluted (loss) earnings per share is determined by adjusting the earnings or loss attributable to common shareholders and the weighted average number of common shares outstanding for the effects of dilutive instruments, which includes stock options, as if their dilutive effect was at the beginning of the period. The calculation of the diluted number of common shares assumes that proceeds received from the exercise of “in-the- money” stock options and common share purchase warrants are used to purchase common shares of the Company at their average market price for the period.
In periods that the Company reports a net loss, any stock options or warrants outstanding are excluded from the calculation of diluted loss per share as their inclusion would be anti-dilutive.
Functional and foreign currency
The Company’s functional currency is NIS. However, the presentation currency is the U.S. dollar (“USD”). Transactions and balances are converted into USD in accordance with the principles set forth by International Accounting Standard (IAS) 21 “The Effects of Changes in Foreign Exchange Rates.” Accordingly, transactions and balances have been converted as follows:
| ● | Assets and liability items were reported at closing rate of exchange at the statements of financial position date. |
| ● | Other comprehensive income items were reported at annual average rate of exchange at the statements of financial position date. |
| ● | Share capital, capital reserve and other capital movement items were at rate of exchange as of the date of recognition of those items. |
| ● | Accumulated deficit was based on the opening balance for the beginning of the reporting period in addition to the movements mentioned above. |
| ● | Rate of exchange rate differentials created was recognized in other comprehensive income and accumulated in equity. |
Fair value measurement
Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. The fair value measurement is based on the presumption that the transaction to sell the asset or transfer the liability takes place either:
| A. | In the principal market for the asset or liability, or |
| B. | In the absence of a principal market, in the most advantageous market for the asset or liability. |
The principal or the most advantageous market must be accessible by the Company in order to measure an asset or liability by its fair value.
F-12
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (CONT.):
The fair value of an asset or a liability is measured using the assumptions that market participants would use when pricing the asset or liability, assuming that market participants act in their economic best interest. A fair value measurement of a non-financial asset takes into account a market participant’s ability to generate economic benefits by using the asset in its highest and best use or by selling it to another market participant that would use the asset in its highest and best use.
When there are no quoted prices in active markets for identical assets or liabilities, the Company uses valuation techniques that are appropriate in the circumstances and for which sufficient data is available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs.
Classification by fair value hierarchy Assets and liabilities measured in the statement of financial position at fair value are grouped into classes with similar characteristics using the following fair value hierarchy which is determined based on the source of input used in measuring fair value:
Level 1 - Quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level 2 - Inputs other than quoted prices included within Level 1 that are observable either directly or indirectly.
Level 3 - Inputs that are not based on observable market data (valuation techniques that use inputs that are not based on observable market data).
Financial instruments
| 1. | Financial assets |
The Company classifies its financial assets into the following category, based on the business model for managing the financial asset and its contractual cash flow characteristics. The Company’s accounting policy for the relevant category is as follows:
Amortized cost: other types of financial assets where the objective is to hold these assets in order to collect contractual cash flows and the contractual cash flows are solely payments of principal and interest. They are initially recognized at fair value including direct transaction costs and are subsequently carried at amortized cost using the effective interest rate method, less provision for impairment.
| 2. | Financial Liabilities |
The Company classifies its financial liabilities, including trade accounts payable and other accounts payable, which are initially recognized at fair value and subsequently carried at amortized cost using the effective interest method. The financial liabilities at fair value (see also Notes 8 and 19) are measured at fair value through profit or loss.
| 3. | De-recognition |
| ● | Financial assets - The Company derecognizes a financial asset when the contractual rights to the cash flows from the financial asset expire or it transfers the rights to receive the contractual cash flows. |
| ● | Financial Liabilities - The Company derecognizes a financial liability when its contractual obligations are discharged or cancelled or expire. |
F-13
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (CONT.):
| 4. | Impairment of financial assets |
The Company does not have any assets which require a recognition of expected credit losses (“ECL”).
Cash and cash equivalents are subject to the impairment requirements of IFRS 9, the Company did not identify impairment for the cash and cash equivalent.
Property, plant, and equipment
Items of property, plant and equipment are initially recognized at cost including directly attributable costs. Depreciation is calculated on a straight-line basis, over the useful lives of the assets at annual rates as follows:
| Annual depreciation rate (%) | ||||
| Computers | ||||
| Development equipment | ||||
| Furniture and office equipment | ||||
| Leasehold Improvements | ||||
Subsequent costs are included in the asset’s carrying amount or recognized as a separate asset, as appropriate, only when it is probable that future economic benefits associated with the item will flow to the group and the cost of the item can be measured reliably. The carrying amount of any component accounted for as a separate asset is derecognized when replaced. All other repairs and maintenance are charged to statement of the comprehensive loss during the reporting period in which they are incurred. The assets’ residual values and useful lives are reviewed, and adjusted if appropriate, at the end of each reporting period. An asset’s carrying amount is written down immediately to its recoverable amount if the asset’s carrying amount is higher than its estimated recoverable amount.
Gains and losses on disposals are determined by comparing proceeds with carrying amount. These are included in statement of the comprehensive loss.
Impairment of non-financial assets
Non-financial assets are subject to impairment test whenever events or changes in circumstances indicate that their carrying amount may not be recoverable. Where the carrying value of the non-financial asset exceeds its recoverable amount (i.e., the higher of value in use and fair value less costs to dispose), the asset is written down and impairment charge is recognized accordingly.
Where it is not possible to estimate the recoverable amount of an individual asset, the impairment test is carried out on the asset’s cash-generating unit (i.e., the smallest group of assets to which the asset belongs that generates cash inflow that is largely independent of cash inflows from other assets).
F-14
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (CONT.):
Impairment of non-financial assets (cont.)
An impairment loss allocated to an asset, is reversed only if there have been changes in the estimates used to determine the asset’s recoverable amount since the last impairment loss was recognized.
Reversal of an impairment loss, as above, is limited to the lower of the carrying amount of the asset that would have been determined (net of depreciation or amortization) had no impairment loss been recognized for the asset in prior years and the asset’s recoverable amount. After an impairment of non-financial asset is recognized, the Company examines at each reporting date whether there are indications that the impairment which was recognized in the past no longer exists or should be reduced. The reversal of impairment loss of an asset is recognized in statement of the comprehensive loss. Impairment charges are included in general and administrative expenses in the statement of the comprehensive loss. During the years ended December 31, 2022 and 2021, no impairment charges of non-financial assets were recognized.
Research and development costs
Expenditure on research activities is recognized in statement of the comprehensive loss as incurred. Development expenditures is recognized as an intangible asset when the Company can demonstrate:
| ● | The product is technically and commercially feasible. |
| ● | The Company intends to complete the product so that it will be available for use or sale. |
| ● | The Company has the ability to use the product or sell it. |
| ● | The Company has the technical, financial and other resources to complete the development and to use or sell the product. |
| ● | The Company can demonstrate that the product will generate future economic benefits. |
| ● | The Company is able to measure reliably the expenditure attributable to the product during the development. |
During the years ended December 31, 2021 and 2022, the Company’s research and development costs were not capitalized as they did not meet the criteria set forth in IAS 38.
Segment reporting
An operating segment is a component of the Company which fulfills the following criteria:
| 1. | It is engaged in business operations from which it may derive income, and with respect to which it may bear expenses. |
| 2. | Its operating results are reviewed on a regular basis by the Company’s chief operational decision maker, in order to reach decisions regarding the resources allocated to it, and in order to assess its performance. |
| 3. | Separate financial information is available for the above. |
The Company concluded that it has one operating segment.
Share based payment
The Company measures the share based expense and the cost of equity-settled transactions with employees and service providers by reference to the fair value of the equity instruments at the date at which they are granted.
F-15
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (CONT.):
Options
The fair value is determined using an accepted options pricing model. The model is based on share price, grant date and on assumptions regarding expected volatility, expected life of the options, expected dividend, and a no risk interest rate. The options were granted before the Company became public and had no quoted price per share from a trading market.
The Company selected the Black-Scholes model as the Company’s option pricing model to estimate the fair value of the Company’s options awards. The option-pricing model requires a number of assumptions:
Expected dividend yield - The expected dividend yield assumption is based on the Company’s historical experience and expectation of no future dividend payouts. The Company has not historically paid cash dividends and has no foreseeable plans to pay cash dividends in the future.
Volatility - The expected volatility is based on similar companies’ stock volatility.
Risk free interest rate - The risk-free interest rate is based on the yield of governmental bonds with equivalent terms.
Contractual term - An option’s contractual term is the amount of time the holder has to exercise the option, per the contract.
Restricted Share Units (“RSUs”) - The fair value is measured by multiplying the number of the restricted shares units granted to employees, directors, and subcontractors by the quoted share price as of the grant date.
The granted options are settled in equity instruments and not in cash. The fair value of the options at the date of grant is charged to the statement of comprehensive loss over the vesting period. Non-market vesting conditions are considered by adjusting the number of equity instruments expected to vest at each reporting date so that, ultimately, the cumulative amount recognized over the vesting period is based on the number of options that eventually vest. Non-vesting conditions and market vesting conditions are factored into the fair value of the options granted. As long as all other vesting conditions are satisfied, a charge is made irrespective of whether the market vesting conditions are satisfied. The cumulative expense is not adjusted for failure to achieve a market vesting condition or where a non-vesting condition is not satisfied. Where the terms and conditions of options are modified before they vest, the increase in the fair value of the options, measured immediately before and after the modification, is also charged to the statement of comprehensive loss over the remaining vesting period.
F-16
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (CONT.):
Government grants
The Israel Innovation Authority (“IIA”) provided government grants to the Company for certain research and development activities. The Company may be required to pay royalties to the IIA in the future if it generates sales from the related research and development activity. The grant was recognized as a liability in the financial statements. When the loan bears a below-market rate of interest, the liability is recognized at its fair value in accordance with the market interest rate prevailing at the time of receiving the grant. The difference between the consideration received and the liability recognized at inception was treated as a government grant and recognized as a reimbursement of research expenses. The repayment of the liability to the state is reviewed every reporting period, with changes in the liability resulting from a change in the expected royalties recognized in profit or loss.
Current taxes
The current tax liability is measured using the tax rates and tax laws that have been enacted or substantively enacted by the reporting date as well as adjustments required in connection with the tax liability in respect of previous years. The Company has no tax liability due to its carry forward losses.
Deferred tax
Significant management judgment is required to determine the amount of deferred tax assets that can be recognized, based upon the estimated timing and level of future taxable profits together with future tax planning strategies. Deferred taxes are recognized in respect of temporary differences between the carrying amounts of assets and liabilities in the financial statements and the amounts attributable for tax purposes.
Deferred taxes are measured at the tax rates that are expected to apply in the period when the temporary differences are reversed based on tax laws that have been enacted or substantively enacted at the end of the reporting period. Deferred taxes are recognized in profit or loss, except when they relate to items recognized in other comprehensive income or directly in equity. Deferred tax assets are reviewed at the end of each reporting period and reduced to the extent that it is not probable that they will be utilized. In addition, temporary differences (such as carry forward losses) for which deferred tax assets have not been recognized are reassessed and deferred tax assets are recognized to the extent that their recoverability is probable.
Any resulting reduction or reversal is recognized on “income tax” within the statement of comprehensive income. All deferred tax assets and liabilities are presented in the statement of financial position as non-current items, respectively. Deferred taxes are offset in the statement of financial position if there is a legally enforceable right to offset a current tax asset against a current tax liability and the deferred taxes relate to the same taxpayer and the same taxation authority.
F-17
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (CONT.):
Employee benefits
The Company has several employee benefit plans for Israeli employees:
| 1. | Short-term employee benefits: Short-term employee benefits include salaries, paid annual leave, paid sick leave, recreation and social security contributions, which are recognized as expenses as the services are rendered. A liability in respect of a cash bonus or a profit-sharing plan is recognized when the Company has a legal or constructive obligation to make such payment as a result of past service rendered by an employee and a reliable estimate of the amount can be made. |
| 2. | Post-employment benefits: The plans are normally financed by contributions to insurance companies and classified as defined contribution plans. The Company has contributed for all of its employees’ contribution plans pursuant to Section 14 to the Severance Pay Law since 2018 under which the Company pays fixed contributions and will not have any legal or constructive obligation to pay further contributions if the fund does not hold sufficient amounts to pay all employee benefits relating to employee service in the current and prior periods. |
NOTE 3 - CRITICAL ACCOUNTING ESTIMATES AND JUDGEMENTS:
Share based payments
The fair value of share options was estimated by using a Black Scholes model approach, which was aimed to model the value of the Company’s equity over time. A change of the estimation can cause to recognition or reversal of share based compensation expenses.
Financial liabilities at fair value
The fair value of financial liabilities at fair value was estimated by using a Black Scholes model and Monte-Carlo simulation approach, which was aimed to model the value of the Company’s assets over time. The simulation approach was designed to take into account the terms and conditions financial liability, which are described in Note 8 and Note 20, as well as the capital structure of the Company and the volatility of its assets. The valuation was performed based on management’s assumptions and projections.
Determination of lease incremental borrowing rate
The Company measures the incremental borrowing rate by analyzing similar borrowing that could be obtained from an independent valuation under comparable terms and conditions. A change of the estimation can cause to an increase or decrease in the measurement of a right-of-use asset and lease liability.
NOTE 4 – DEPOSITS
The deposits are three short-term bank deposits with maturities of more than three months but less than one year. The deposits are in dollars and bear annual interest.
On May 10, 2022, the Company deposited
On August 11, 2022, the Company deposited
On August 24, 2022, the Company deposited
As of December 31, 2022 total deposits amounted
to
NOTE 5 - OTHER CURRENT ASSETS:
| December 31, 2022 | December 31, 2021 | |||||||
| Prepaid expenses | ||||||||
| Institutions | ||||||||
| Restricted Cash | ||||||||
| Others | ||||||||
| Total | ||||||||
F-18
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 6 - PROPERTY AND EQUIPMENT, NET:
For the year ended December 31, 2022:
| Computers | Leasehold improvements | Development equipment | Furniture and office equipment | Total | ||||||||||||||||
| Cost | ||||||||||||||||||||
| At January 1, 2022 | ||||||||||||||||||||
| Additions | ||||||||||||||||||||
| Exchange rate deference | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||
| At December 31, 2022 | ||||||||||||||||||||
| Accumulated depreciation | ||||||||||||||||||||
| At January 1, 2022 | ||||||||||||||||||||
| Depreciation | ||||||||||||||||||||
| Exchange rate deference | ( | ) | - | ( | ) | ( | ) | ( | ) | |||||||||||
| At December 31, 2022 | ||||||||||||||||||||
| Net book value: | ||||||||||||||||||||
| As of December 31, 2022 | ||||||||||||||||||||
| * | Less than thousand dollars |
For the year ended December 31, 2021:
| Computers | Leasehold improvements | Development equipment | Furniture and office equipment | Total | ||||||||||||||||
| Cost | ||||||||||||||||||||
| At January 1, 2021 | | | ||||||||||||||||||
| Additions | ||||||||||||||||||||
| At December 31, 2021 | ||||||||||||||||||||
| Accumulated depreciation | ||||||||||||||||||||
| At January 1, 2021 | ||||||||||||||||||||
| Depreciation | ||||||||||||||||||||
| At December 31, 2021 | ||||||||||||||||||||
| Net book value: | ||||||||||||||||||||
| As of December 31, 2021 | ||||||||||||||||||||
| * | Less than one thousand dollars |
F-19
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 7 - OTHER ACCOUNTS PAYABLE:
| December 31, 2022 | December 31, 2021 | |||||||
| Employees salaries and related liabilities | ||||||||
| Related parties | ||||||||
| Accrued expenses | ||||||||
| Other | ||||||||
| Total | ||||||||
NOTE 8 - LIABILITY IN RESPECT OF GOVERNMENT GRANTS:
The Company received the approval of the IIA
for its participation in certain development expenses carried out by the Company, within the framework of determined budgets and time
periods. The total amount the Company received during 2020 and 2021 was
In accordance with its commitment, the Company
is obliged to pay the IIA royalties of
The difference between the consideration received and the liability recognized at inception (present value) was treated as a government grant according to IAS 20 and recognized as a reimbursement of research expenses.
| December 31, 2022 | December 31, 2021 | |||||||
| At January 1, 2022 | ||||||||
| Amounts received during the year, non- capitalized | ||||||||
| Exchange rate differences | ( | ) | ||||||
| Amounts recognized as an offset from research and development expenses | ( | ) | ||||||
| Revaluation of the liability | ||||||||
| As of December 31, 2022 | ||||||||
F-20
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 9 - FINACIAL LIABILITIES AT FAIR VALUE:
December 31, 2022 | December 31, 2021 | |||||||
| Non-tradable warrants (1) | ||||||||
| Non-tradable warrants, SAFE and CLA (2) | ||||||||
| Tradable warrants (3) | ||||||||
| Financial liability (4) | ||||||||
| Total | ||||||||
| 1. | Non Tradable Warrants |
As part of an agreement signed in
2019, the convertible loan investors received, upon conversion in 2020
The warrants were designated to be measured at fair value through profit or loss.
On July 2021, as part of the IPO,
the investors received the specified warrants. As of December 31, 2022 the fair value of the warrants was
| 2. | Non-tradable warrants, SAFE and Convertible Loan Investors |
On July 16, 2021, following the IPO, the Company
issued
The non-tradable warrants fair value as of December
31, 2022 is
| 3. | Tradable warrants |
The Company sold
As of December 31, 2022,
the Company has
The tradable warrants were designated to be measured at fair value through profit or loss.
The tradable warrants fair value as
of December 31, 2022 is
| 4. | Financial Liability |
Financial liability to pay
Financial liability was designated to be measured at fair value through profit or loss.
The Financial liability fair value
as of December 31, 2022 is
F-21
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 10 - EQUITY (DEFICT):
A. Share capital:
| Number of shares as of | Number of shares as of | |||||||||||||||
| December 31, 2022 | December 31, 2021 | |||||||||||||||
| Authorized | Issued and outstanding | Authorized | Issued and outstanding | |||||||||||||
| Ordinary shares | ||||||||||||||||
Since the Company’s incorporation in February
2018 and before the IPO, the Company issued the following Ordinary Shares: (i) an aggregate of
On March 18, 2021, the Company’s shareholders
approved a
On June 1, 2021, the Company’s shareholders
approved an amendment to the structure of the Company’s share capital (both authorized and issued) by cancelling the par value
in addition to implementing an additional reverse split at a ratio of
On June 1, 2021, the Company’s shareholders
approved an amendment to the structure of the Company’s share capital (both authorized and issued) by cancelling the par value
of the Company’s shares such that each Ordinary Share with par value of NIS
On June 1, 2021, the Company’s shareholders
approved an increase in the authorized share capital of the Company to
On July 16, 2021, the Company completed its IPO
on Nasdaq Capital Market whereby the Company sold
Following the IPO, the Company issued
The aggregate proceeds received by the Company
from the IPO were approximately
Total non-cash direct expenses in IPO were as following: (i) fair value of 436,364 tradable warrants that were granted to underwriters totaled 589; (ii) The Company issued 145,455 non-tradable warrants as underwriters fees; the warrants will be converted into Ordinary Shares of the Company at an exercise price equal to 125% of the initial public offering price and be exercisable for three years after the initial public offering. As of the date of the IPO, the tradable warrants fair value was 264; and (iii) the Company agreed to pay to a promoter 7% of the proceeds from the exercise of tradable warrants. The payment was measured according to IFRS 2 at the grant date. As of the IPO date, the fair value of the financial liability was 310.
Total non-cash expenses were
F-22
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 10 - EQUITY (DEFICT) (CONT.):
In addition, the Company had non-direct expenses
as following: (i) cash expenses amounted to
Total IPO expanse direct and non direct, cash
and non-cash were:
Total IPO expenses allocated to the profit and
loss were
During the year 2021 the Company issued an aggregate
amount of
On December 17, 2021, the Company’s shareholders
approved an increase in the authorized share capital of the Company to
During the year ended December 31 2022, the Company
issued an aggregate amount of
B. Loss per share:
Loss per share has been calculated using the weighted average number of shares in issue during the relevant financial periods, the weighted average number of equity shares in issue and profit for the period as follows:
| Year ended December 31, 2022 | Year ended December 31, 2021 | Year ended December 31, 2020 | ||||||||||
| Loss for the period | ||||||||||||
| Total number of Ordinary Shares | ||||||||||||
| Weighted average number of Ordinary Shares | ||||||||||||
| ( | ) | ( | ) | ( | ) | |||||||
NOTE 11 - RESEARCH AND DEVELOPMENT EXPENSES:
| Year ended December 31, 2022 | Year ended December 31, 2021 | Year ended December 31, 2020 | ||||||||||
| Share based payment | ||||||||||||
| Salary and related expenses | ||||||||||||
| Subcontractors | ||||||||||||
| Materials and related expenses | ||||||||||||
| Depreciation | ||||||||||||
| IIA participation | - | ( | ) | ( | ) | |||||||
| Other | ||||||||||||
| Total | ||||||||||||
F-23
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 12 - SALES AND MARKETING EXPENSES:
| Year ended December 31, 2022 | Year ended December 31, 2021 | Year ended December 31, 2020 | ||||||||||
| Share based payment | ||||||||||||
| Salary and related expenses | ||||||||||||
| Professionals’ fees | ||||||||||||
| Other | ||||||||||||
NOTE 13 - GENERAL AND ADMINISTRATIVE EXPENSES:
| Year ended December 31, 2022 | Year ended December 31, 2021 | Year ended December 31, 2020 | ||||||||||
| Share based payment | ||||||||||||
| Professional fees | ||||||||||||
| Related NASDAQ IPO expenses | ||||||||||||
| Director’s fees and share based compensation | ||||||||||||
| Salary and related expenses | ||||||||||||
| Insurance expenses | ||||||||||||
| Office maintenance | ||||||||||||
| Depreciation | ||||||||||||
| Travel abroad | ||||||||||||
| Others | ||||||||||||
| Total | ||||||||||||
F-24
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 14 – FINANCIAL (INCOME) AND EXPENSES:
| Income | Year ended December 31, 2022 | Year ended December 31, 2021 | Year ended December 31, 2020 | |||||||||
| Revaluation of financial liabilities at fair value through profit or loss | ( | ) | ||||||||||
| Foreign currency transaction income | ( | ) | ||||||||||
| Interest on deposits | ( | ) | ( | ) | ||||||||
| Others | ( | ) | ||||||||||
| Total | ( | ) | ( | ) | ||||||||
| Expenses | Year ended December 31, 2022 | Year ended December 31, 2021 | Year ended December 31, 2020 | |||||||||
| Revaluation of financial liabilities at fair value through profit or loss | ||||||||||||
| Foreign currency transaction loss, net | - | |||||||||||
| Revaluation of liability in respect of government grants | ||||||||||||
| Finance expense in respect of lease liability | ||||||||||||
| Others | ||||||||||||
| Total | ||||||||||||
NOTE 15 - TAXES ON INCOME:
Taxes on income:
Israeli corporate
tax rate was
Net operating losses carry forwards:
As of December 31, 2022, the Company has carried
forward tax losses of approximately
Theoretical tax:
| Year ended December 31, 2022 | Year ended December 31, 2021 | Year ended December 31, 2020 | ||||||||||
| Loss before taxation | ( | ) | ( | ) | ( | ) | ||||||
| Theoretical tax credit at applicable statutory rate: | ( | ) | ( | ) | ( | ) | ||||||
| Non-allowable expenses | ( | ) | ( | ) | ||||||||
| Temporary differences and tax losses for which no Deferred Tax Asset is recognized | ( | ) | ( | ) | ( | ) | ||||||
| Income tax benefit | ||||||||||||
F-25
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 16 - LEASES:
The Company has lease contracts for office facilities
and vehicles used in its operations. Leases of vehicles generally have lease terms up to
The Company leases vehicles for three-year periods from several different leasing companies and from time to time changes the number of leased vehicles according to its current needs. The leased vehicles are used by the Company’s management, and other employees whose employment agreements include an obligation of the Company to put a vehicle at their disposal. The Company accounted for the arrangement between it and the leasing companies as a lease arrangement in the scope of IFRS 16 and for the arrangement between it and its employees as an arrangement in the scope of IAS 19, Employee Benefits. The agreements with the leasing companies do not contain extension and/or termination options that the Company is reasonably certain to exercise.
A lease liability in the amount of
The Company leases offices in Ra’anana are for a period of 69 months. The contractual period of the aforesaid lease agreement ends in August 2027. The Company has an option to terminate the contract after 45 months with a penalty in amount of NIS 500,000 that will be diminish in NIS 30,000 in each month from the 45th month of the contract. The Company does not currently expect to exercise the termination option in the lease agreement.
A lease liability in the amount of
Set out below are the carrying amounts of right-of-use assets recognized and the movements during the period:
| Office facility | Vehicles | Total | ||||||||||
| At January 1, 2022 | ||||||||||||
| Additions | ||||||||||||
| Exchange rate differences | ( | ) | ( | ) | ( | ) | ||||||
| Disposals | ( | ) | ( | ) | ||||||||
| Depreciation expense | ( | ) | ( | ) | ( | ) | ||||||
| As of December 31, 2022 | ||||||||||||
Set out below are the carrying amounts of lease liabilities and the movements during the period:
| 2022 | 2021 | 2020 | ||||||||||
| At January 1, 2022 | ||||||||||||
| Additions | ||||||||||||
| Accretion of interest | ||||||||||||
| Financial expenses | ( | ) | ||||||||||
| Exchange rate differences | ( | ) | ||||||||||
| Disposals | ( | ) | ( | ) | ||||||||
| Payment | ( | ) | ( | ) | ( | ) | ||||||
| As of December 31, 2022 | ||||||||||||
F-26
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 16 - LEASES (CONT.):
The following are the amounts recognized in profit or loss:
| Year ended December 31, 2022 | Year ended December 31, 2021 | Year ended December 31, 2020 | ||||||||||
| Depreciation expense of right-of-use assets | ||||||||||||
| Interest expense on lease liabilities | ||||||||||||
| Total amount recognized in profit or loss | ||||||||||||
The Company had total cash outflows for leases
of
NOTE 17 - SHARE BASED PAYMENT:
In December 2019, the Company established a share
option plan (the “Plan”). Under the Plan, total of
A total of
On April 20, 2020 a total of
On December 17, 2020, the Israeli Taxes Authority
(ITA) approved a ruling request from the Company for a tax-free amendment of the commercial terms of the outstanding options, including
(i) a reduction of the exercise price to NIS
The Company implemented IFRS 2-Share based payment on options terms change.
On December 20, 2020, the board of directors
granted a total of
Contractual life of the options under the Plan
is
On February 21, 2021,
F-27
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 17 - SHARE BASED PAYMENT (CONT.):
On March 16, 2021, the Company’s board
of directors approved a grant of
On August 12, 2021, the Company’s board
of directors resolved to increase the pool of options available under the Plan to
On November 2, 2021, the Company’s board of directors approved
a grant of
On November 2, 2021, the Company’s
board of directors approved a grant of
On March 24, 2022,
On March 24, 2022,
On April 6, 2022,
On May 19, 2022,
On November 22, 2022,
F-28
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 17 - SHARE BASED PAYMENT (CONT.):
The fair value of all granted options was estimated by using the Black Scholes model, which was aimed to model the value of the Company’s assets over time. The simulation approach was designed to take into account the terms and conditions of the share options, as well as the capital structure of the Company and the volatility of its assets, on the date of grant based on certain assumptions. Those conditions are, among others:
| (i) | The expected volatility is between 50%-52.4% |
| (ii) | The dividend rate 0%; and |
| (iii) | Expected term – three years. |
The valuation was completed with the assistance of an independent valuator based on management’s assumptions.
During the year ended December 31, 2022, the Company recorded share
based payment expenses to employees, directors and subcontractors in the amount of
The options to services providers and advisers outstanding as of December 31, 2022, as follows:
| Year ended December 31, 2022 | ||||||||
| Number of options | Weighted average Exercise price NIS | |||||||
| Outstanding at beginning of year | ||||||||
| Granted | ||||||||
| Exercised | ( | ) | ||||||
| Forfeited | ||||||||
| Outstanding as of December 31, 2022 | ||||||||
| Exercisable options | ||||||||
During the year ended December 31, 2022, the Company recorded share
based payment expenses of option to services providers and advisers in the amount of
The RSUs to services providers and advisers outstanding as of December 31, 2022 as follows:
| Number of RSUs | ||||
| Outstanding at beginning of year | ||||
| Granted | ||||
| Vested | ( | ) | ||
| Outstanding as of December 31, 2022 | ||||
| Vested as of December 31, 2022 | ||||
F-29
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 17 - SHARE BASED PAYMENT (CONT.):
During the year ended December 31, 2022, the
Company recorded share based payment expenses of RSUs to services providers and advisers in the amount of
The options to employees and directors outstanding as of December 31, 2022, as follows:
| Year ended December 31, 2022 |
||||||||
| Number of options | Weighted average Exercise price NIS | |||||||
| Outstanding at beginning of year | ||||||||
| Exercised | ||||||||
| Forfeited | ( |
) | ||||||
| Outstanding as of December 31, 2022 | ||||||||
| Exercisable options | ||||||||
During the year ended December 31, 2022, the Company recorded share
based payment expenses of options to employees and directors in the amount of
The RSUs to employees and directors outstanding as of December 31, 2022, as follows:
| Number of RSUs | ||||
| Outstanding at beginning of year | ||||
| Granted | ||||
| Forfeited | ( | ) | ||
| Vested | ( | ) | ||
| Outstanding as of December 31, 2022 | ||||
| Vested as of December 31, 2022 | ||||
During the year ended December 31, 2022, the
Company recorded share based payment expenses of RSUs to employees and directors in the amount of
F-30
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 17 - SHARE BASED PAYMENT (CONT.):
The options to services providers and advisers outstanding as of December 31, 2021, as follows:
| Year ended December 31, 2021 | ||||||||
| Number of options | Weighted average Exercise price NIS | |||||||
| Outstanding at beginning of year | ||||||||
| Reclassified to employees and directors | ( | ) | ||||||
| Granted | ||||||||
| Exercised | ( | ) | ||||||
| Forfeited | ( | ) | ||||||
| Outstanding as of December 31, 2021 | ||||||||
| Exercisable options | ||||||||
The RSUs to services providers and advisers outstanding as of December 31, 2021, as follows:
| Number of RSUs | ||||
| Outstanding at beginning of year | ||||
| Granted | ||||
| Outstanding as of December 31, 2021 | ||||
| Exercisable RSUs | ||||
The options to employees and directors outstanding as of December 31, 2021, as follows:
| Year ended December 31, 2021 | ||||||||
| Number of options | Weighted average Exercise price NIS | |||||||
| Outstanding at beginning of year | ||||||||
| Reclassified to employees and directors | ||||||||
| Granted | ||||||||
| Exercised | ( | ) | ||||||
| Forfeited | ( | ) | ||||||
| Outstanding as of December 31, 2021 | ||||||||
| Exercisable options | ||||||||
The restricted shares units to employees and directors outstanding as of December 31, 2021, as follows:
| Number of RSUs | ||||
| Outstanding at beginning of year | ||||
| Granted | ||||
| Vested | ( | ) | ||
| Outstanding as of December 31, 2021 | ||||
F-31
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 18 - RELATED PARTIES:
The following transactions arose with related parties:
Transactions and balances with related parties:
| 1. | Shareholders and other related parties’ benefits |
| December 31, 2022 | December 31, 2021 | December 31, 2020 | ||||||||||
| Salary and related expenses – officers and directors | ||||||||||||
| Share based payment – officers and directors | ||||||||||||
| 2. | Balances with related parties |
| Name | Nature of transaction | December 31, 2022 | December 31, 2021 | |||||||
| Officers | ||||||||||
| Directors | ||||||||||
NOTE 19 - FINANCIAL INSTRUMENTS AND RISK MANAGEMENT:
The Company is exposed to a variety of financial risks, which result from its financing, operating and investing activities. The objective of financial risk management is to contain, where appropriate, exposures in these financial risks to limit any negative impact on the Company’s financial performance and position. The Company’s financial instruments are its cash and other current assets, convertible loan, payables and other payables. The main purpose of these financial instruments is to raise finance for the Company’s operation. The Company actively measures, monitors, and manages its financial risk exposures by various functions pursuant to the segregation of duties and principals. The risks arising from the Company’s financial instruments are mainly credit risk and currency risk. The risk management policies employed by the Company to manage these risks are discussed below.
Credit risk
Credit risk arises when a failure by counterparties to discharge their obligations could reduce the amount of future cash inflows from financial assets on hand at the balance sheet date. The Company closely monitors the activities of its counterparties and controls the access to its intellectual property which enables it to ensure the prompt collection. The Company’s main financial assets are cash and cash equivalents and deposits represent the Company’s maximum exposure to credit risk in connection with its financial assets. Wherever possible and commercially practical, the Company holds cash with major financial institutions in Israel.
F-32
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 19 - FINANCIAL INSTRUMENTS AND RISK MANAGEMENT (CONT.):
The carrying amount of financial assets represents the maximum credit exposure. The maximum exposure to credit risk at the reporting date was:
| December 31, 2022 | December 31, 2021 | |||||||
| Cash and cash equivalents | ||||||||
| Deposits | ||||||||
| Other current assets (Restricted deposits) | ||||||||
| Total | ||||||||
Currency risk
Currency risk is the risk that the value of financial instruments will fluctuate due to changes in foreign exchange rates. Currency risk arises when future commercial transactions and recognized assets and liabilities are denominated in a currency that is not the Company’s functional currency. The Company exposed to foreign exchange risk arising from currency exposure primarily with respect to the USD. The Company’s policy is not to enter into any currency hedging transactions.
The carrying amounts of the Company’s foreign currency denominated monetary liability at the reporting date are as follows:
| December 31, 2022 | December 31, 2021 | |||||||
| Assets | ||||||||
| Cash and cash equivalents | ||||||||
| Deposits | ||||||||
| Liabilities | ||||||||
| Financial liabilities | ||||||||
| Total | ||||||||
| Net | ||||||||
Sensitivity analysis
A
| Year ended December 31, | Year ended December 31, | |||||||
| 2022 | 2021 | |||||||
| USD | ||||||||
| AUD | ||||||||
| GB Pound | ||||||||
F-33
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 19 - FINANCIAL INSTRUMENTS AND RISK MANAGEMENT (CONT.):
Liquidity risks:
Liquidity risk is the risk that arises when the maturity of assets and the maturity of liabilities do not match. An unmatched position potentially enhances profitability but can also increase the risk of loss. The Company has procedures to minimize such loss by maintaining sufficient cash and other highly liquid current assets and by having available an adequate amount of committed credit facilities. As of the balance sheet date, the Company has a negative working capital.
The following tables detail the Company’s remaining contractual maturity for its financial liabilities. The tables have been drawn up based on the undiscounted cash flows of financial liabilities based on the earliest date on which the Company can be required to pay.
As of December 31, 2022:
| Up to 1 year | Between 1 and 3 years | More than 3 years | ||||||||||
| Other payables | ||||||||||||
| Lease liabilities | ||||||||||||
| Trade payables | ||||||||||||
| Loan from the IIA | ||||||||||||
| Total | ||||||||||||
As of December 31, 2021:
| Up to 1 year | Between 1 and 3 years | More than 3 years | ||||||||||
| Other payables | ||||||||||||
| Lease liabilities | ||||||||||||
| Trade payables | ||||||||||||
| Loan from the IIA | ||||||||||||
| Total | ||||||||||||
F-34
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 20 - COMMITMENTS AND CONTINGENCIES
Commitments
| 1. | The Company has a bank guarantee in the amount of 63 for the offices it rents. In accordance with the guarantee, the Company has a pledged deposit in the same amount as of December 31, 2022. |
| 2. | In July 2022, the Company entered into an agreement with a contractor for the development of the HYLA™ blood sensor. Total payment agreed in the contract is 710. According to the agreement with the developer, the development cost will be paid in a few tranches considering the development lifecycle, which was defined as five phases for each of the blood parameters to be measured by the sensor. |
The Company is entitled to terminate the contract upon reaching the third phase.
| 3. | As of December 31, 2022, part of the development outputs
reached the second phase and part are on the third phase. Approximately half of the contract total amount was recorded as development
expenses as of December 31, 2022. An amount of |
Contingencies
| 1. | In the normal course of business, various legal claims and other contingent matters may arise. Management believes that any liability that may arise from such matters would not have a material adverse effect on the Company’s results of operations or financial condition as of and for the years ended December 31, 2022, and 2021. |
| 2. | On March 4, 2022, Exchange Listing, LLC, or Exchange, filed
a complaint in the Federal Court for the Southern District of New York against us in connection with a contract between the parties.
The contract related to certain consulting services provided to us by Exchange in preparation for our initial public offering.The complaint
is against us and, and the Company president and former Chief Financial Officer, Joe Hayon, in connection with a contract between the
parties pursuant to which Exchange provided certain consultancy services to us in preparation for our initial public offering. The precise
damages sought are unclear, however Exchange is seeking approximately |
| 3. | On November 9, 2022, the Company received notice of a complaint filed by Udi Nussinovitch, the Registrant’s former Chief Scientific Officer, in Tel-Aviv District Court, as well as a complaint filed with the regional labor court in Tel Aviv on November 8, 2022. Mr. Nussinovitch has alleged certain deficiencies in the Company’s Extraordinary General Meeting of Shareholders held on Friday, December 17, 2021, resulting from his status as a minority shareholder. In addition, with respect to the labor dispute, Mr. Nussinovitch is seeking renumeration and the issuance of Ordinary Shares. Previously, on February 24, 2022, the Company filed a claim against Mr. Nussinovitch for breach good faith and his fiduciary duties as a shareholder and former officer of the Company. |
As of the balance date, the Company believes that the claims will result in no payments by the Company.
F-35
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 21 - FAIR VALUE MEASUREMENT:
Fair value hierarchy
The following tables detail the Company’s assets and liabilities, measured or disclosed at fair value, using a three-level hierarchy, based on the lowest level of input that is significant to the entire fair value measurement, being:
Level 1: Quoted prices (unadjusted) in active markets for identical assets or liabilities that the entity can access at the measurement date.
Level 2: Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly.
Level 3: Unobservable inputs for the asset or liability.
As of December 31, 2022:
| Level 1 | Level 2 | Level 3 | ||||||||||
| Non-tradable Warrants | ||||||||||||
| Non-tradable warrants of SAFE and Convertible Loan investors | ||||||||||||
| Financial liability | ||||||||||||
| Tradable warrants | ||||||||||||
| Total | ||||||||||||
As of December 31, 2021:
| Level 1 | Level 2 | Level 3 | ||||||||||
| Non-tradable Warrants | ||||||||||||
| Non-tradable warrants of SAFE and Convertible Loan investors | ||||||||||||
| Financial liability | ||||||||||||
| Tradable warrants | ||||||||||||
| Total | ||||||||||||
As of December 31, 2022, the fair value measurement of the warrant’s securities in the table above, was estimated using the Black Scholes model, based on assumptions for the variables that are required as of the warrants’ valuation date.
The key inputs that were used in the both items
of non-tradable warrants valuation were: risk-free interest rate between
F-36
INSPIRA TECHNOLOGIES OXY B.H.N. LTD.
NOTES TO FINANCIAL STATEMENTS
(U.S. dollars in thousands)
NOTE 21 - FAIR VALUE MEASUREMENT (Cont.):
As of December 31, 2021, the fair value measurement of the SAFE and the warrant’s securities in the table above, was estimated using the Black Scholes model, based on a variety of significant unobservable inputs a thus represent a level 2 measurement within the fair value hierarchy.
The key inputs that were used in both items of
non-tradable warrants valuation were: risk-free interest rate between
The carrying amounts of trade and other receivables and trade and other payables are assumed to approximate their fair values due to their short-term nature.
Movements in level 2 liability during 2021 is set out below:
| Warrants | SAFE | Convertible loan | Financial Liability | Total | ||||||||||||||||
| Balance as of December 31, 2020 | ||||||||||||||||||||
| Gains (losses) recognized in profit or loss | ( | ) | ||||||||||||||||||
| Additions | ||||||||||||||||||||
| Interest | ||||||||||||||||||||
| Conversion | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| Adjustments arising from translating financial operation | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| Balance as of December,31 2021 | ||||||||||||||||||||
F-37
Exhibit 12.1
CERTIFICATION PURSUANT TO EXCHANGE ACT RULE 13a-14(a) or 15d-14(a)
I, Dagi Ben-Noon, certify that:
| 1. | I have reviewed this annual report on Form 20-F/A of Inspira Technologies Oxy B.H.N. Ltd. (the “company”); |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report; |
| 4. | The company’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have: |
| a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| c) | Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| d) | Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting. |
| 5. | The company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent function): |
| a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and |
| b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting. |
| Date: April 19, 2023 | /s/ Dagi Ben-Noon |
| Dagi Ben-Noon | |
| Chief Executive Officer |
Exhibit 12.2
CERTIFICATION PURSUANT TO EXCHANGE ACT RULE 13a-14(a) or 15d-14(a)
I, Yafit Tehila, certify that:
| 1. | I have reviewed this annual report on Form 20-F/A of Inspira Technologies Oxy B.H.N. Ltd. (the “company”); |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report; |
| 4. | The company’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have: |
| a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
| c) | Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| d) | Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting. |
| 5. | The company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent function): |
| a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and |
| b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting. |
| Date: April 19, 2023 | /s/ Yafit Tehila |
| Yafit Tehila | |
| Chief Financial Officer |
Exhibit 13.1
CERTIFICATION PURSUANT TO
18 U.S.C. Section 1350
In connection with the filing of the Annual Report on Form 20-F/A for the period ended December 31, 2022 (the “Report”) by Inspira Technologies Oxy B.H.N. Ltd. (the “company”), the undersigned, as the Chief Executive Officer of the company, hereby certifies pursuant to 18 U.S.C. Section 1350, that, to my knowledge:
(1) the Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the company.
| Date: April 19, 2023 | /s/ Dagi Ben-Noon |
| Dagi Ben-Noon | |
| Chief Executive Officer |
Exhibit 13.2
CERTIFICATION PURSUANT TO
18 U.S.C. Section 1350
In connection with the filing of the Annual Report on Form 20-F/A for the period ended December 31, 2022 (the “Report”) by Inspira Technologies Oxy B.H.N. Ltd. (the “company”), the undersigned, as the Chief Financial Officer of the company, hereby certifies pursuant to 18 U.S.C. Section 1350, that, to my knowledge:
(1) the Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the company.
| Date: April 19, 2023 | /s/ Yafit Tehila |
| Yafit Tehila | |
| Chief Financial Officer |
Exhibit 15.1
 |
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
Inspira Technologies Oxy B.H.N. Ltd.
2 Ha-Tidhar St.
Rananna 4366504, Israel
We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (No. 333-259057) and Form F-3 (No. 333-266748) of Inspira Technologies Oxy B.H.N Ltd (“the Company”) of our report dated March 28, 2023, relating to the financial statements of the Company which appears in this Annual Report on Form 20-F.
| /s/ Ziv Haft | |
|
Certified Public Accountants (Isr.) BDO Member Firm |
Tel Aviv, Israel
April 19, 2023