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Form 6-K Inspira Technologies For: Aug 11

August 11, 2022 10:08 AM EDT

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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: August 2022 (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

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  

 

 

 

 

 

 

CONTENTS

 

On August 11, 2022, Inspira Technologies Oxy B.H.N. Ltd., or the Registrant, issued a press release titled “Inspira™ Technologies Reports Second Quarter 2022 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, the section titled “Highlights,” the section titled “Financial Results for the Six Months Ended June 30, 2022,” and the section titled “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and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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 August 11, 2022, titled “Inspira™ Technologies Reports Second Quarter 2022 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: August 11, 2022 By: /s/ Dagi Ben-Noon
    Name:  Dagi Ben-Noon
    Title: Chief Executive Officer

.

 

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Exhibit 99.1

 

 

 

Inspira™ Technologies Reports Second Quarter 2022 Financial Results

 

As of June 30, 2022, the Company had $19.2 million in cash

 

August 11, 2022

 

Ra’anana, Israel– Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the “Company” or “Inspira Technologies”), a groundbreaking respiratory support technology company, announced today its financial results for the second quarter ended June 30, 2022.

 

Dagi Ben-Noon, Chief Executive Officer of Inspira Technologies, stated: The Company continues to meet its scheduled major objectives and improve its position within the target market of direct blood oxygenation. Our focus on contributing to medical advancement within this space is exemplified by the introduction of our new HYLATM, a non-invasive blood sensor being designed to perform real-time and continuous blood measurements. The HYLATM is being designed to assist physicians in the monitoring of a patient’s clinical condition, alerting of a sudden change in the patient’s vital signs, which may require immediate medical attention and potentially save lives.

 

Planned as a technically advanced component for the InspiraTM ART system, the HYLATM will also have its own distinct target market and business model.

 

Recently, Inspira also revealed the first public pictures of the ALICE™ Device, designed as a cardiopulmonary bypass (CPB) or heart-lung bypass device. We continue to strategically enhance our presence within the market as we prepare to enter the verification and validation (V&V) process with the U.S. Food and Drug Administration (FDA) approval of our technologies.”

 

 

 

 

 

 

Highlights:

 

ØApril 6, 2022 - Inspira Technologies announced a deployment agreement for the InspiraTM ART system in the Israeli market to potentially target $15 million. The agreement is for a 7-year period and subject to regulatory approval.

 

ØJuly 6, 2022 - Inspira Technologies announced the development of the HYLATM Non-Invasive Blood Sensor designed to assist physicians in monitoring a patient’s clinical condition, potentially targeting the $2.5 billion arterial blood gas (ABG) market.

 

ØJuly 7, 2022 - Inspira Technologies announced a strategic agreement in the U.S. with a potential value of $59 million for the deployment of 3,889 HYLA™ Blood Sensors. The agreement is for a three-year period and is subject to regulatory approval.

 

ØJuly 11, 2022 - Inspira Technologies revealed the ALICE™ Device, designed as a cardiopulmonary bypass (CPB) or heart-lung bypass device, designed to oxygenate and circulate blood for up to 6 hours during cardiac surgery.

 

 

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Financial Results for the Six Months Ended June 30, 2022

 

Research and development expenses for the six months ended June 30, 2022, were $4.3 million, compared to $1.1 million for the corresponding period in 2021. The increase is a result of the Company’s recruitment of specialized manpower and the expanded development of its new technologies and operations.

 

Marketing expenses for the six months ended June 30, 2022, were $777,000, compared to $244,000 for the corresponding period in 2021. The increase is attributed to rises in marketing, payroll, and share-based compensation expenses. Marketing activities commenced in the first quarter of 2021 and became more intensive with the Company’s need to create brand awareness and explore go-to-market capabilities.

 

General and administrative (G&A) expenses for the six months ended June 30, 2022, were $2.9 million, compared to $1.2 million for the corresponding period in 2021. The increase stemmed primarily from an uptick in payroll and related expenses, as well as costs associated with the Company’s status as a publicly traded company following its initial public offering (IPO) on Nasdaq in July 2021, the increase in existing and new expenses included professional fees, director fees, and directors’ and officers’ insurance costs.

 

Finance income for the six months ended June 30, 2022, was $4.5

million, compared to expenses in the amount of $5.7 million for the corresponding period in 2021. The increase in finance income derived from the calculation of the fair value of the Company’s financial equity liabilities to pre-IPO and IPO investors in addition to the fluctuation in the USD exchange rate during the first half of 2022.

 

Net loss for the six months ended June 30, 2022, was $3.5 million, compared to a net loss of $8.2 million for the six months ended June 30, 2021.

 

Financial highlights for the quarter ended June 30, 2022

 

Research and development expenses for the three months ended June 30, 2022, were $2.7 million, an increase of $1.2 million compared to the first quarter of 2022. The increase was attributed to share-based compensation expenses in addition to expected R&D expenditures on new technologies and new projects.

 

General and administrative expenses for the three months ended June 30, 2022, were $1.4 million, a non-material decrease of $0.2 million compared to the first quarter of 2022.

 

Sales and Marketing expenses for the three months ended June 30, 2022, were $0.3 million, a decrease of approximately $0.17 million compared to the first quarter of 2022.

 

Balance Sheet highlights

 

Cash, cash equivalents, and short-term bank deposits were $19.2 million as of June 30, 2022, compared to $23.7 million as of December 31, 2022.

 

Financial liabilities at fair value totaled $0.4 million as of June 30, 2022, compared to $3.2 million on December 31, 2021. The financial liabilities represent the fair value of the Company’s equity liabilities to pre-IPO and IPO investors.

 

As of June 30, 2022, shareholders’ equity totaled $17.8 million, compared to shareholders’ equity totaling $20.3 million as of December 31, 2021.

 

 

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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. The Company’s technology potentially allows patients to remain awake during treatment while minimizing the need for highly invasive, risky, and costly mechanical ventilation systems that require intubation and medically induced coma. The Company’s product has 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/

 

Forward-Looking Statement Disclaimer

 

ØThis 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 meeting milestones in 2022 and the timing for such milestones, its various products in development and the benefits that such products may provide, its various strategic agreements and the potential amounts that may be derived under such agreements, all subject to regulatory approval. 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, 2021 filed with the SEC, which is available on the SEC’s website, www.sec.gov.

 

For more details:

 

Investor Relations, MS-IR LLC

Miri Segal,

+917-607-8654 [email protected]

 

US Public Relations

 

Dave Gentry

RedChip Companies Inc.

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

Or 407-491-4498

[email protected]

 

MRK-ARS-033 Copyright © 2018-2022 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)

 

   June 30,   December 31, 
   2022   2021 
ASSETS        
Current Assets:        
Cash and cash equivalents   14,154    23,749 
Cash deposits   5,020    - 
Other accounts receivable   195    639 
Restricted cash   67    120 
Total current assets   19,436    24,508 
           
Non-Current Assets:          
Right of use assets, net   1,101    1,160 
Property, plant and equipment, net   208    202 
Total non-current assets   1,309    1,362 
Total Assets   20,745    25,870 

 

   June 30,   December 31, 
   2022   2021 
LIABILITIES AND SHAREHOLDERS’ EQUITY        
Current Liabilities:        
Trade accounts payables   50    93 
Other accounts payable   1,114    725 
Lease liabilities   309    281 
Financial Liabilities at Fair Value   439    3,215 
Total current liabilities   1,912    4,314 
           
Non-Current Liabilities:          
Lease liabilities   787    900 
Loan from the Israeli Innovation Authority   293    302 
Total non- current liabilities   1,080    1,202 
           
Shareholders’ Equity:          
Share capital and premium   52,042    48,935 
Foreign exchange reserve   (2,025)   210 
Accumulated deficit   (32,264)   (28,791)
Total equity   17,753    20,354 
Total Liabilities and Shareholders’ Equity   20,745    25,870 

 

  

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UNAUDITED CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE INCOME

(US dollars in thousands)

 

   For the Three Months Ended
June 30,
   For the Six Months Ended
June 30,
 
   2022   2021   2022   2021 
                 
Research and development expenses   2,734    437    4,294    1,104 
Marketing expenses   305    114    777    244 
General and administrative expenses   1,392    389    2,936    1,210 
Operating loss   4,431    940    8,007    2,558 
Finance expenses (income)   (2,338)   59    (4,534)   5,732 
Loss (profit) before tax   2,093    999    3,473    8,290 
Taxes on income                    
Loss (profit) for the period   2,093    999    3,473    8,290 
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   (1,810)   182    (2,235)   (33)
Total comprehensive loss for the period   3,903    817    5,708    8,323 

 

 

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CONDENSED INTERIM STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

(US dollars in thousands)

 

For the Three-Month Period Ended June 30, 2022 (Unaudited):

 

   Share
capital
and
premium
   Adjustments
arising from
translating
financial
operation
   Accumulated
deficit
   Total 
Balance on March 31, 2022                
Changes during the period:   50,189    (215)   (30,171)   19,803 
Loss for the period   -    -    (2,093)   (2,093)
Other comprehensive loss   -    (1,810)   -    (1,810)
Total comprehensive loss   -    (1,810)   (2,093)   (3,903)
Share-based compensation   1,853    -    -    1,853 
Balance on June 30, 2022   52,042    (2,025)   (32,264)   17,753 

 

For the Six-Month Period Ended June 30, 2022 (Unaudited):

 

   Share
capital
and
premium
   Adjustments
arising from
translating
financial
operation
   Accumulated
deficit
   Total 
Balance on January 01, 2022                
Changes during the period:   48,935    210    (28,791)   20,354 
Loss for the period   -    -    (3,473)   (3,473)
Other comprehensive loss   -    (2,235)   -    (2,235)
Total comprehensive loss   -    (2,235)   (3,473)   (5,708)
Share-based compensation   3,107    -    -    3,107 
Balance on June 30, 2022   52,042    (2,025)   (32,264)   17,753 

 

 

 

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