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6-K 1 ea178873-6k_inspiratech.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 May 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 May 18, 2023, Inspira Technologies Oxy B.H.N.

 

 

 

 


 

CONTENTS

 

Ltd., or the Registrant, issued a press release titled “Inspira™ Technologies Reports First 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 paragraph and the sections titled “Highlights,” “Financial Results for the Three Months Ended March 31, 2023,” “Balance Sheet Highlights,” and “Forward-Looking Statements” in the press release 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and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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 May 18, 2023, titled “Inspira™ Technologies Reports First 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: May 18, 2023 By: /s/ Dagi Ben-Noon
    Name:  Dagi Ben-Noon
    Title: Chief Executive Officer

 

 

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EX-99.1 2 ea178873ex99-1_inspiratech.htm PRESS RELEASE ISSUED BY INSPIRA TECHNOLOGIES OXY B.H.N. LTD. ON MAY 18, 2023, TITLED "INSPIRA TECHNOLOGIES REPORTS FIRST QUARTER 2023 FINANCIAL RESULTS.''

Exhibit 99.1

 

 

Inspira™ Technologies Reports First Quarter 2023 Financial Results

 

As of March 31, 2023, the Company had $11.5 million in cash, cash equivalents, and short-term bank deposits.

 

May 18, 2023

 

Ra’anana, Israel– Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the “Company” or “Inspira Technologies”), a company aiming to revolutionize acute respiratory care, announced today its financial results for the first quarter ended March 31, 2023.

 

Dagi Ben-Noon, Chief Executive Officer of Inspira Technologies, stated:

 

“We believe that this is a very important period for the Company, as we continue to progress towards the regulatory submission of the New ALICETM Device with the U.S. Food and Drug Administration (FDA) in the coming months. This is in addition to the ongoing clinical studies of the HYLATM non-invasive blood sensor currently underway at Sheba Medical Centre in Israel. The progress of these devices represents important building blocks of our flagship INSPIRATM ART system, which is advancing in the development process.”

 

Highlights:

 

Ø May 11, 2023 – We announced that we are developing the VORTX™ Blood Oxygenator, a disposable oxygenator unit (kit) that uses a unique technology for saturating blood with oxygen and removing carbon dioxide. The VORTX is being designed to be sold separately to an addressable market currently estimated at $1.16 billion as well as being made compatible with our INSPIRA ART system and ALICE device.

 

Ø March 22, 2023 - We announced a First in Human of HYLA™ Blood Sensor in a clinical study. We also announced the first use of the HYLATM in a patient undergoing open-heart surgery at Sheba Medical Centre in Israel.

 

Ø February 13, 2023 - We announced that we received approval from Sheba Medical Centre to conduct a clinical study of the HYLA™ Blood Sensor.

 

Ø January 23, 2023 - We announced that we were granted a patent by the U.S. Patent Office for the INSPIRA™ ART System’s Convertible Dual Lumen Cannula Device and Method of Use. All 20 claims were found to be novel, with inventive step and industrial applicability.

 

 

 


 

 

Financial Results for the Three Months Ended March 31, 2023

 

Research and development expenses for the three months ended March 31, 2023, were $2.0 million, compared to $1.5 million for the corresponding period in 2022. The increase is a result of the Company’s recruitment of employees and the expanded research and development of its new technologies and operations.

 

Marketing expenses for the three months ended March 31, 2023, were $168 thousand compared to $472 thousand for the corresponding period in 2022. The decrease is attributable to decreases in share-based compensation expenses and a reduction in marketing activities. The marketing department increase its efforts in the first quarter of 2022 with respect to brand awareness and exploring go-to-market capabilities.

 

General and administrative expenses for the three months ended March 31, 2023, were $1.0 million, compared to $1.5 million for the corresponding period in 2022. The decrease resulted primarily from a decrease in share-based compensation expenses.

 

Finance income for the three months ended March 31, 2023, was $368 thousand, compared to $2.2 million for the corresponding period in 2022. The change in finance income resulted primarily from the calculation of the fair value of the Company’s financial equity liabilities to pre-initial public offering (IPO) and IPO investors, in addition to the fluctuation in the U.S. dollar – New Israeli Shekel exchange rate during the first quarter of 2023.

 

Finance expenses for the three months ended March 31, 2023, were $112 thousand, compared to $25 thousand for the corresponding period in 2022.

 

Net loss for the three months ended March 31, 2023, was $3.0 million, compared to a net loss of $1.3 million for the three months ended March 31, 2022.

 

Balance Sheet Highlights

 

Cash, cash equivalents and short-term bank deposits were $11.5 million as of March 31, 2023, compared to $13.9 million as of December 31, 2022.

 

Financial liabilities at fair value totalled $431 thousand as of March 31, 2023, compared to $368 thousand as of December 31, 2022. The financial liabilities represent the fair value of the Company’s equity liabilities to pre-IPO and IPO investors.

 

As of March 31, 2023, the Company’s shareholders’ equity totalled $10 million, compared to shareholders’ equity totalling $12.8 million as of December 31, 2022.

 

Inspira Technologies OXY B.H.N. Ltd.

 

Inspira Technologies is an innovative medical technology company in the respiratory treatment arena. The Company has developed a breakthrough Augmented Respiration Technology (INSPIRA ART), designed to rebalance patient oxygen saturation levels. This technology potentially allows patients to remain awake during treatment while preventing the need for highly invasive, risky, and costly mechanical ventilation systems that require intubation and medically induced coma. The Company’s products have not yet been tested or used in humans and has not been approved by any regulatory entity.

 

For more information, please visit our corporate website: 

https://inspira-technologies.com/

 

 

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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 its regulatory strategy, the continuation of its progress towards the regulatory submission of the ALICE Device with the FDA, the progress of its clinical studies, and its believe that the progress of its devices represents important building blocks of its INSPIRA ART system. These forward-looking statements and their implications are based solely on the current expectations of the Company’s management 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. 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.

 

US Public Relations

Dave Gentry

RedChip Companies Inc.

1-800-RED-CHIP (733-2447)

Or 407-491-4498

IINN@redchip.com

 

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

(US dollars in thousands)

 

    March 31,     December 31,  
    2023     2022  
             
ASSETS            
Current Assets:            
Cash and cash equivalents     6,362       6,783  
Cash deposits     5,136       7,120  
Other accounts receivable     371       591  
Total current assets     11,869       14,494  
                 
Non-Current Assets:                
Right of use assets, net     1,004       1,107  
Property, plant and equipment, net     535       411  
Total non-current assets     1,539       1,518  
Total Assets     13,408       16,012  

 

    March 31,     December 31,  
    2023     2022  
             
LIABILITIES AND SHAREHOLDERS’ EQUITY            
Current Liabilities:            
Trade accounts payables     191       150  
Other accounts payable     1,350       1,217  
Lease liabilities     307       329  
Financial Liabilities at Fair Value     431       368  
Total current liabilities     2,279       2,064  
                 
Non-Current Liabilities:                
Lease liabilities     637       728  
Loan from the Israeli Innovation Authority     412       398  
Total non- current liabilities     1,049       1,126  
                 
Shareholders’ Equity:                
Share capital and premium     54,397       53,814  
Foreign exchange reserve     (2,222 )     (1,928 )
Accumulated deficit     (42,095 )     (39,064 )
Total equity     10,080       12,822  
Total Liabilities and Shareholders’ Equity     13,408       16,012  

 

 

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UNAUDITED CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE INCOME

(US dollars in thousands)

 

    For the Three Months Ended     For the Year Ended  
    March 31,     December 31,  
    2023     2022     2022  
                   
Research and development expenses     2,054       1,560       8,054  
Marketing expenses     168       472       1,325  
General and administrative expenses     1,065       1,544       5,391  
Operating loss     3,287       3,576       14,770  
Finance (income)     (368 )     (2,196 )     (4,678 )
Finance expenses     112               181  
Loss (profit) before tax     3,031       1,380       10,273  
Taxes on income                        
Loss (profit) for the period     3,031       1,380       10,273  
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     (294 )     (425 )     (2,138 )
Total comprehensive loss for the period     3,325       1,805       12,411  

 

 

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CONDENSED INTERIM STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

(US dollars in thousands)

 

For the Three-Month Period Ended March 31, 2023 (Unaudited):

 

    Share
capital and premium
    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     -       -       (3,031 )     (3,031 )
Other comprehensive loss     -       (294 )     -       (294 )
Total comprehensive loss     -       (294 )     (3,031 )     (3,325 )
Share-based compensation     583       -       -       583  
Balance on March 31, 2023     54,397       (2,222 )     (42,095 )     10,080  

 

 

 

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