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6-K 1 ea188583-6k_inspira.htm REPORT OF FOREIGN PRIVATE ISSUER

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

For the Month of: November 2023 (Report No. 3)

 

Commission File Number: 001-40303

 

Inspira Technologies Oxy B.H.N. Ltd.

(Translation of registrant’s name into English)

 

2 Ha-Tidhar St.

Ra’anana 4366504, Israel

(Address of principal executive office)

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

 

☒ Form 20-F ☐ Form 40-F On November 16, 2023, Inspira Technologies Oxy B.H.N.

 

 

 

 


 

CONTENTS

 

Ltd., or the Registrant, issued a press release titled “Inspira™ Technologies Reports Third Quarter 2023 Financial Results,” a copy of which is furnished as Exhibit 99.1 with this report of foreign private issuer on Form 6-K.

 

The first two paragraphs, the sections “Financial Results for the Nine Months Ended September 30, 2023,” “Financial highlights for the three months ended September 30, 2023,” “Balance Sheet highlights” and “Forward-Looking Statement Disclaimer” are incorporated by reference into the Registrant’s Registration Statements on Form F-3 (Registration No. 333-266748) and Form S-8 (Registration No. 333-259057), filed with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished. 

 

Exhibit No.    
99.1   Press Release issued by Inspira Technologies Oxy B.H.N. Ltd. on November 16, 2023, titled “Inspira™ Technologies Reports Third Quarter 2023 Financial Results.”

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

  Inspira Technologies Oxy B.H.N. Ltd.
     
Date: November 16, 2023 By: /s/ Dagi Ben-Noon
    Name:   Dagi Ben-Noon
    Title: Chief Executive Officer

 

 

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EX-99.1 2 ea188583ex99-1_inspira.htm PRESS RELEASE ISSUED BY INSPIRA TECHNOLOGIES OXY B.H.N. LTD. ON NOVEMBER 16, 2023, TITLED "INSPIRA TM TECHNOLOGIES REPORTS THIRD QUARTER 2023 FINANCIAL RESULTS."

Exhibit 99.1

 

 

 

Inspira™ Technologies Reports Third Quarter 2023 Financial Results

 

Ra’anana, Israel, November 16, 2023 – Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the “Company” or “Inspira”), a pioneer in acute respiratory care, today announced its financial results for the third quarter ended September 30, 2023. This quarter, Inspira continued to progress in the development of its novel technology for oxygenating blood, an alternative to traditional mechanical ventilation for respiratory patients. This patented technology, recently bolstered by a grant from the Israeli Innovation Authority and new U.S. patents, is at the heart of Inspira's strategy.

 

Key business developments include the Company’s preparation for U.S. Food and Drug Administration (FDA) approval of Inspira’s ART100 device and its securing of potentially significant distribution agreements in Europe and Central America. These steps align with Inspira's goal to disrupt the $20 billion respiratory ventilator market.

 

“We are incredibly pleased with our progress over the last quarter,” remarked Dagi Ben-Noon, Chief Executive Officer of Inspira. “This period has been marked by significant achievements in both our business strategy and our intellectual property portfolio. Our innovative approach to respiratory care, which we believe is at the forefront of medical technology, has not only received recognition in the form of patents and grants but is also steadily moving toward commercial realization.”

 

Financial Results for the nine months ended September 30, 2023

 

Research and development expenses for the nine months ended September 30, 2023, were $5.37 million, compared to $6.24 million for the corresponding period in 2022. The reason for the decrease in research and development expenses was primarily the result of the decrease in share-based compensation expenses, which was more significant than the increase in the salary and related expenses from the Company’s recruitment of employees and the expansion of its research and development department.

 

Sales and marketing expenses for the nine months ended September 30, 2023, were $0.59 million compared to $1.08 million for the corresponding period in 2022. The decrease is attributable to a decrease in share-based compensation expenses and a reduction in marketing activities. The marketing department increased its efforts in the first half of 2022 with respect to brand awareness and exploring go-to-market capabilities.

 

General and administrative expenses for the nine months ended September 30, 2023 were $3.01 million, compared to $4.29 million for the corresponding period in 2022. The decrease is primarily due to the decrease in share-based compensation expenses and a lower cost of director and officer insurance.

 

Finance income for the nine months ended September 30, 2023, was $0.86 million, compared to $4.51 million for the corresponding period in 2022. The decrease in finance income is primarily due to the calculation of the fair market value of the Company’s warrants issued to investors in its pre-initial public offering and initial public offering (IPO) as financial equity liabilities and the fluctuation in the U.S. Dollar – New Israeli Shekel exchange rate during the first half of 2023.

 

 

 


 

 

Finance expenses for the nine months ended September 30, 2023 were $0.16 million, compared to $0.04 million for the corresponding period in 2022. The increase in finance expenses is primarily due to the calculation of the fair market value of the Company’s warrants issued to investors in its pre-IPO and IPO as financial equity liabilities.

 

The net loss for the nine months ended September 30, 2023, was $8.28 million, compared to a net loss of $7.15 million for the nine months ended September 30, 2022.

 

Financial highlights for the three months ended September 30, 2023

 

Research and development expenses for the three months ended September 30, 2023, were $1.54 million, compared to $1.95 million for the corresponding period in 2022. The decrease is due to the decrease in share-based compensation expenses and a decrease in expenses related to projects initiated in the third quarter of 2022.

 

Sales and marketing expenses for the three months ended September 30, 2023, were $0.19 million compared to $0.3 million for the corresponding period in 2022. The reason for the decrease in sales and marketing expenses was due to the decrease in share-based compensation expenses.

 

General and administrative expenses for the three months ended September 30, 2023, were $0.91 million, compared to $1.36 million for the corresponding period in 2022. The decrease is due primarily to a decrease in share-based compensation expenses and a lower cost of director and officer insurance.

 

Finance income for the three months ended September 30, 2023 was $0.22 million, compared to $0.07 million for the corresponding period in 2022. The decrease in finance income is due primarily to the calculation of the fair market value of the Company’s warrants issued to investors in its pre-IPO and IPO as financial equity liabilities, in addition to the fluctuation in the U.S. Dollar – New Israeli Shekel exchange rate during the first half of 2023.

 

There were no finance expenses for the three months ended September 30,2023, compared to $0.14 million for the corresponding period in 2022.

 

Balance Sheet Highlights

 

Cash, cash equivalents and short-term bank deposits were $6.39 million as of September 30, 2023, compared to $13.9 million as of December 31, 2022.

 

Financial liabilities at fair market value totaled $0.36 million as of September 30, 2023, compared to $0.37 million as of December 31, 2022. The financial liabilities represent the fair market value of the Company’s warrants being accounted for as equity liabilities issued to pre-IPO and IPO investors.

 

As of September 30, 2023, the Company’s shareholders’ equity totaled $5.17 million, compared to shareholders’ equity totaling $12.82 million as of December 31, 2022.

 

 

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Inspira Technologies OXY B.H.N. Ltd.

 

Inspira Technologies is at the forefront of revolutionizing acute respiratory care by introducing groundbreaking medical technologies. Central to its mission is the development of innovative solutions that enable direct blood oxygenation, bypassing the lungs. This pioneering approach sets Inspira apart by potentially eliminating the reliance on traditional mechanical ventilation, which is often associated with higher risks and complexities. Beyond this, the Company is committed to advancing blood circulation technology and incorporating AI-driven monitoring systems. These advancements are part of its strategy to offer more patient-focused, data-informed care. The integration of these technologies signifies the potential to enhancing patient outcomes and streamlining hospital operations, marking a new era in respiratory care.

 

For more information, please visit our corporate website: 

https://inspira-technologies.com/

 

Forward-Looking Statement Disclaimer

 

This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. For example, the Company is using forward-looking statements when it discusses the Company’s goal to disrupt the respiratory ventilator market and the Company’s move toward commercial realization of its medical technology. Except as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2022 filed with the SEC, which is available on the SEC’s website, www.sec.gov.

 

MRK-ARS-057 Copyright © 2018-2023 Inspira Technologies OXY B.H.N. LTD., All rights reserved.

 

 

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UNAUDITED CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION

(U.S. dollars in thousands)

 

    September 30,     December 31,  
    2023     2022  
ASSETS            
Current Assets:            
Cash and cash equivalents     3,327       6,783  
Cash deposits     3,061       7,120  
Other current assets     431       591  
Total current assets     6,819       14,494  
                 
Non-Current Assets:                
Right of use assets, net     862       1,107  
Property, plant and equipment, net     482       411  
Total non-current assets     1,344       1,518  
Total Assets     8,163       16,012  

 

    September 30,     December 31,  
    2023     2022  
LIABILITIES AND SHAREHOLDERS’ EQUITY            
Current Liabilities:            
Trade accounts payables     307       150  
Other accounts payable     1,083       1,217  
Lease liabilities     287       329  
Financial liabilities at fair value     363       368  
Total current liabilities     2,040       2,064  
                 
Non-Current Liabilities:                
Lease liabilities     502       728  
Loan from the Israeli Innovation Authority     452       398  
Total non- current liabilities     954       1,126  
                 
Shareholders’ Equity:                
Share capital and additional paid-in capital     55,131       53,814  
Foreign exchange reserve     (2,620 )     (1,928 )
Accumulated deficit     (47,342 )     (39,064 )
Total equity     5,169       12,822  
Total liabilities and shareholders’ equity     8,163       16,012  

 

 

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UNAUDITED CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

(U.S. dollars in thousands)

 

    For the Three Months Ended
September 30,
    For the Nine Months Ended
September 30,
 
    2023     2022     2023     2022  
                         
Research and development expenses     1,542       1,948       5,372       6,242  
Marketing expenses     193       301       594       1,078  
General and administrative expenses     907       1,357       3,011       4,293  
Operating loss     2,642       3,606       8,977       11,613  
Finance income     (219 )     (69 )     (856 )     (4,508 )
Finance expenses     -       135       157       40  
Loss (profit) before tax     2,423       3,672       8,278       7,145  
Taxes on income                                
Loss (profit) for the period                                
Other comprehensive loss (profit), net of tax:                                
Items that will not be reclassified to profit or loss:                                
Exchange profits (losses) arising on translation to presentation currency     260       (58 )     692       (2,293 )
Total comprehensive loss for the period     2,683       3,730       8,970       9,438  

 

 

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UNAUDITED CONDENSED INTERIM STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

(U.S. dollars in thousands)

 

For the Three-Month Period Ended September 30, 2023 (Unaudited):

 

    Share
capital and
additional
paid-in
capital
    Adjustments
arising from
translating
financial
operation
    Accumulated
deficit
    Total  
Balance on June 30, 2023                        
Changes during the period:     54,831       (2,360 )     (44,919 )     7,552  
Loss for the period     -       -       (2,423 )     (2,423 )
Other comprehensive loss     -       (260 )     -       (260 )
Total comprehensive loss     -       (260 )     (2,423 )     (2,683 )
Share-based compensation     300       -       -       300  
Balance on September 30, 2023     55,131       (2,620 )     (47,342 )     5,169  

 

For the nine-month Period Ended September 30, 2023 (Unaudited):

 

    Share
capital and
additional
paid-in
capital
    Adjustments
arising from
translating
financial
operation
    Accumulated
deficit
    Total  
Balance on January 1, 2023                        
Changes during the period:     53,814       (1,928 )     (39,064 )     12,822  
Loss for the period     -       -       (8,278 )     (8,278 )
Other comprehensive loss     -       (692 )     -       (692 )
Total comprehensive loss     -       (692 )     (8,278 )     (8,970 )
Share-based compensation     1,317       -       -       1,317  
Balance on September 30, 2023     55,131       (2,620 )     (47,342 )     5,169  

 

 

 

 

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