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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 October 2025

 

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 This Report of Foreign Private Issuer on Form 6-K consists of Inspira Technologies Oxy B.H.N.

 

 

 


 

CONTENTS

 

Ltd.’s (the “Registrant”): (i) press release issued on October 1, 2025, titled “Inspira Technologies Reports First Half 2025 Financial Results and Issues Business Update,” which is attached hereto as Exhibit 99.1; (ii) Unaudited Interim Condensed Consolidated Financial Statements as of June 30, 2025, which is attached hereto as Exhibit 99.2; and (ii) Management’s Discussion and Analysis of Financial Condition and Results of Operations for the six months ended June 30, 2025, which is attached hereto as Exhibit 99.3.

 

The Report on Form 6-K is incorporated by reference into the Registrant’s Registration Statements on Form F-3 (Registration Nos. 333-266748, 333-284308 and 333-289324) and Form S-8 (Registration Nos. 333-259057, 333-277980 and 333-285565), 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and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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 October 1, 2025, titled “Inspira Technologies Reports First Half 2025 Financial Results and Issues Business Update.”
99.2   Inspira Technologies Oxy B.H.N. Ltd.’s Unaudited Interim Condensed Consolidated Financial Statements as of June 30, 2025.
99.3   Inspira Technologies Oxy B.H.N. Ltd.’s Management’s Discussion and Analysis of Financial Condition and Results of Operation for the Six Months Ended June 30, 2025.
101   The following financial information from the Registrant’s Interim Condensed Financial Statements as of June 30, 2025, formatted in XBRL (eXtensible Business Reporting Language): (i) Interim Condensed Statements of Financial Position, (ii) Interim Condensed Statements of Comprehensive Loss, (iii) Interim Condensed Statements of Changes in Shareholders’ Equity; (iv) Interim Condensed Statements of Cash Flows, and (v) Notes to the Unaudited Interim Condensed Financial Statements.
104   Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

 

1


 

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: October 1, 2025 By: /s/ Dagi Ben-Noon
    Name:  Dagi Ben-Noon
    Title: Chief Executive Officer

 

 

2

 

 

EX-99.1 2 ea025460401ex99-1_inspira.htm PRESS RELEASE ISSUED BY INSPIRA TECHNOLOGIES OXY B.H.N. LTD. ON OCTOBER 1, 2025, TITLED "INSPIRA TECHNOLOGIES REPORTS FIRST HALF 2025 FINANCIAL RESULTS AND ISSUES BUSINESS UPDATE."

Exhibit 99.1

 

 

Inspira Technologies Reports First Half 2025 Financial Results and Issues Business Update

 

Inspira delivered major milestones throughout and following the six months ended June 30, 2025, including the receipt of $49.5 million in binding purchase orders, clinical validation in leading hospitals, 97.35% accuracy for its HYLA blood sensor, and strategic patent protection, underscoring accelerating commercial momentum.

 

RA’ANANA, Israel, October 1, 2025 -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (“Inspira” or the “Company”), a pioneer in innovative life-support and diagnostic technologies, today announced its financial results for the six-month period ended June 30, 2025, and issued a business update.

 

“The first half of 2025 represents a pivotal transformation for Inspira as we have successfully transitioned from being a development-stage company to commencing commercial execution. Our technology is now saving lives in premier U.S. hospitals while generating growing commercial interest globally,” said Dagi Ben-Noon, Chief Executive Officer of Inspira. “With $49.5 million in binding purchase orders secured and clinical validation at leading medical institutions, including for complex lung transplant procedures, we are witnessing the accelerated adoption of our breakthrough platform. Our HYLA blood sensor’s 97.35% accuracy results position us well for our planned U.S. Food & Drug Administration (“FDA”) submission and further strengthens our outlook. As we are in position to scale manufacturing to meet this confirmed global demand, driven by the fulfillment of these orders and our expanding pipeline, we are targeting an annual revenue run rate of at least $70 million in 2026. To ensure we fully capitalize on this momentum, we have also engaged a leading strategic advisory firm to help guide our execution and unlock further avenues for growth, reinforcing our position as a transformative force in advanced respiratory care.”

  

Recent Business and Operational Updates:

 

Generated first commercial revenue commitments in April 2025 and subsequently secured binding purchase orders totaling $49.5 million for the INSPIRA™ ART100 (“ART100”) system in July and August 2025, including a $22.5 million order and a $27 million order from a national ministry of health in Africa. The Company expects to recognize these revenues during 2026.

 

Successfully completed the first human treatment using the ART100 system at the Westchester Medical Center in April 2025, validating the technology’s performance in a real-world clinical environment.

 

Expanded the use of the ART100 system to lung transplantation procedures at a top U.S. News & World Report Honor Roll hospital in September 2025.

 


 

Achieved 97.35% accuracy for the HYLA™ blood sensor in September 2025, advancing towards FDA submission.

 

Received U.S. patent approval in August 2025 for the INSPIRA™ ART500 core technology, with protection until at least 2043.

 

Engaged a U.S.-based strategic consulting firm in July 2025 to accelerate transformational initiatives, including strategic partnerships and corporate development pathways, aimed at maximizing enterprise value.

 

Achieved above 99% gas exchange efficiency in VORTX™ technology during in-vivo animal testing in April 2025.

 

Regained compliance with Nasdaq’s minimum bid price requirement in July 2025.

 

Financial Results for the Six Months Ended June 30, 2025

 

Gross profit: As of June 30, 2025, the Company recognized revenues of $289,000 from sales of the FDA-cleared Inspira ART100 and carts, with a corresponding cost of revenues of $287,000, which includes discounts in connection with first deployment. The Company anticipates substantial revenue recognition from the $49.5 million in binding purchase orders to begin in the first half of 2026 and continue through the second half of 2026, with expected gross margins significantly higher than those recognized during initial deployments.

 

Operating Expenses: Total operating expenses increased to $7,235,000 for the six months ended June 30, 2025, compared to $5,806,000 during the same period in 2024. The reason for the increase in operating expenses is attributable mainly to General and Administrative expenses as we describe below.

 

R&D Investments: Research and development (“R&D”) expenses increased to $3,638,000 for the six months ended June 30, 2025, from $3,270,000 in the same period in 2024. The increase is attributable mainly to the increase in personnel and salaries, exchange rate differences between NIS and USD, and an increase in share-based compensation.

 

G&A Expenses: General and administrative (“G&A”) expenses increased to $3,150,000 for the six months ended June 30, 2025, from $2,182,000 in the same period in 2024. The increase is primarily attributable to share based compensation expenses related to (i) the accelerated vesting of our former president’s restricted share units and (ii) salary expenses as part of our former president’s termination package, pursuant to his employment agreement. The increase is also attributable to a general increase in salaries, in part due to the other officer’s and employee’s share-based compensation expenses.

 

Sales and Marketing: Sales and marketing (“S&M”) expenses increased to $442,000 for the six months ended June 30, 2025, from $349,000 in the same period in 2024. The increase is attributable to the increase in share-based compensation expenses and commercialization expenses.

 

2


 

Cash Position: As of June 30, 2025, the Company had cash, cash equivalents and deposits of $2,126,000 compared to $5,779,000 as of December 31, 2024. On September 16, 2025, the Company increased the aggregate offering price under the at-the-market offering facility to $14,686,641, of which an aggregate of $4,701,062 of shares were sold as of October 01, 2025.

 

Financial Liabilities: As of June 30, 2025, financial liabilities at fair value totaled $886,000 compared to $1,575,000 as of December 31, 2024. The financial liabilities represent the fair value of the Company’s equity liabilities.

 

Net Loss: Net loss was $6,398,000 for the six months ended June 30, 2025, compared to a net loss of $6,240,000 for the six months ended June 30, 2024.

 

About Inspira Technologies

 

Inspira Technologies is a commercial-stage medical device company specializing in advanced respiratory support and real-time blood monitoring solutions. The Company’s U.S. Food and Drug Administration -cleared INSPIRA™ ART100 system is approved for cardiopulmonary bypass in the U.S. and ECMO (Extracorporeal Membrane Oxygenation) procedures outside the U.S and serves as a foundation for the development of the INSPIRA ART500, a next-generation system designed to deliver oxygenation while patients remain awake and spontaneously breathing. Inspira Technologies is also advancing HYLA™, a proprietary blood sensor platform offering continuous, non-invasive monitoring. With multiple cleared products, a growing IP portfolio, and strategic streamlining of its operations, Inspira Technologies is increasingly positioned as an attractive platform within the life-support and MedTech landscape. The Company’s recent internal shifts may reflect broader alignment with long-term industry trends, including consolidation, cross-sector collaboration, and potential strategic partnerships. For more information, visit: https://inspira-technologies.com

 

For more information, visit: 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 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 benefits and advantages of its technology and devices, its belief that its HYLA blood sensor’s accuracy results position it well for its FDA submission and strengthens its outlook, its targeted annual revenue run rate and timing thereof, its expectation to recognize revenues and timing thereof, and the belief that its engagement with a strategic advisory firm will unlock further avenues for growth and reinforce its position as a transformative force in advanced respiratory care. 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, 2024, filed with the U.S. Securities and Exchange Commission (the “SEC”), which is available on the SEC’s website at www.sec.gov.

 

Company Contact
Inspira Technologies – Media Relations
Email: info@inspirao2.com
Phone: +972-9-9664485

 

IR Contact

Arx Investor Relations

North American Equities Desk

inspira@arxhq.com

 

3


 

STATEMENTS OF BALANCE SHEETS

(US dollars in thousands)

 

    June 30,     December 31,  
    2025     2024  
ASSETS            
Current Assets:            
Cash and cash equivalents     2,126       5,111  
Cash deposits     -       668  
Other accounts receivable     418       587  
Inventory     711       444  
Total current assets     3,255       6,810  
                 
Non-Current Assets:                
Right of use assets, net     670       761  
Property, plant and equipment, net     527       499  
Total non-current assets     1,197       1,260  
Total Assets     4,452       8,070  

 

    June 30,     December 31,  
    2025     2024  
LIABILITIES AND SHAREHOLDERS’ EQUITY            
Current Liabilities:            
Trade accounts payables     170       154  
Other accounts payable     1,478       1,364  
Lease liabilities     292       277  
Financial Liabilities at Fair Value     886       1,575  
Total current liabilities     2,826       3,370  
                 
Non-Current Liabilities:                
Lease liabilities     348       378  
Total non-current liabilities     348       378  
                 
Shareholders’ Equity:                
Share capital and additional paid in capital     74,250       70,896  
Accumulated deficit     (72,972 )     (66,574 )
Total equity     1,278       4,322  
Total Liabilities and Shareholders’ Equity     4,452       8,070  

 

4


 

STATEMENTS OF COMPREHENSIVE LOSS

(US dollars in thousands)

 

    Six months
June 30,
2025
    Six months
June 30,
2024
 
             
Revenues     289       -  
Cost of revenues     287       -  
Gross Profit     2       -  
                 
Research and development expenses     3,638       3,270  
General and administrative expenses     3,150       2,182  
Sales and marketing expenses     442       349  
Other expenses (income)     7       5  
Operating loss     7,235       5,806  
Interest Income from deposits     (37 )     (83 )
Finance expenses (income), net     (800 )     517  
Loss before tax     6,398       6,240  
Taxes on income     -       -  
Total comprehensive loss for the period     6,398       6,240  

 

5


 

STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

(US dollars in thousands)

 

For the six months ended June 30, 2025:

 

    Number of
shares
    Share
capital
and
additional
paid in
capital
    Accumulated
deficit
    Total  
Balance on January 1, 2025     24,252,096       70,896       (66,574 )     4,322  
Changes during the period:                                
Issuance of ordinary shares and Pre-funded warrants, net     2,575,753       1,508       -       1,508  
Exercise of options     81,633       8       -       8  
Exercise of Pre-funded warrants     658,372       *       -       -  
Restricted share unit vesting     1,083,443       -       -       -  
Share-based compensation     -       1,838       -       1,838  
Comprehensive and net loss     -       -       (6,398 )     (6,398 )
Balance on June 30, 2025     28,651,297       74,250       (72,972 )     1,278  

 

* Less than one thousand

 

For More Financial Information:

 

For a comprehensive understanding of the Company’s financial reports and related management’s discussion and analysis for applicable periods, please review the Company’s annual report on Form 20-F for the fiscal year ended December 31, 2024, and the Company’s Form 6-K containing the unaudited condensed consolidated financial statements for the six months ended June 30, 2025, both available on the Company’s EDGAR profile at https://www.sec.gov/edgar

 

6

Exhibit 99.2

 

 

 

 

 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD.

 

 

INTERIM CONDENSED FINANCIAL STATEMENTS

 

AS OF JUNE 30, 2025

UNAUDITED

 

 

_______________________

________________

____________

 

 

 


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD.

(UNAUDITED)

 

TABLE OF CONTENTS

 

    Page
     
Interim condensed balance sheets   3 – 4
Interim condensed statements of comprehensive loss   5
Interim condensed statements of changes in shareholders’ equity   6
Interim condensed statements of cash flows   7 – 8
Notes to the interim condensed financial statements   9 – 20

 

2


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD.

UNAUDITED INTERIM CONDENSED BALANCE SHEETS

(U.S. dollars in thousands)

 

 

        June 30,     December 31,  
    Note   2025     2024  
ASSETS                    
Current Assets:                    
Cash and cash equivalents         2,126       5,111  
Deposits        
-
      668  
Other current assets         418       587  
Inventory   3     711       444  
Total current assets         3,255       6,810  
                     
Non-Current Assets:                    
Right of use assets, net         670       761  
Property, plant and equipment, net         527       499  
Total non-current assets         1,197       1,260  
Total Assets         4,452       8,070  

 

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

 

3


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD.

UNAUDITED INTERIM CONDENSED BALANCE SHEETS

(U.S. dollars in thousands)

 

        June 30,     December 31,  
    Note   2025     2024  
LIABILITIES AND SHAREHOLDERS’ EQUITY                
Current Liabilities:                
Trade accounts payable         170       154  
Other accounts payable         1,478       1,364  
Lease liabilities         292       277  
Financial liabilities at fair market value   4     886       1,575  
Total current liabilities         2,826       3,370  
                     
Non-Current Liabilities:                    
Lease liabilities         348       378  
Total non- current liabilities         348       378  
                     
Shareholders' Equity:                    
    Ordinary shares, no par value:
Authorized 100,000,000 as of June 30, 2025 and December 31, 2024; issued and outstanding 28,651,297 shares as of June 30, 2025 and 24,252,096 shares as of December 31, 2024
       
-
     
-
 
Share capital and additional paid-in capital   8     74,250       70,896  
Accumulated losses         (72,972 )     (66,574 )
Total Shareholders' Equity         1,278       4,322  
Total Liabilities and Shareholders' Equity         4,452       8,070  

 

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

 

4


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD.

UNAUDITED INTERIM CONDENSED STATEMENTS OF COMPREHENSIVE LOSS

(U.S. dollars in thousands)

 

          Six months ended
June 30,
    Six months ended
June 30,
 
    Note     2025     2024  
Revenues     5       289      
-
 
Cost of revenues     6       287      
-
 
Gross Profit             2      
-
 
                         
Research and development expenses             3,638       3,270  
General and administrative expenses             3,150       2,182  
Sales and marketing expenses             442       349  
Other expenses             7       5  
Operating loss             7,235       5,806  
Interest income from deposits             (37 )     (83 )
Finance expenses (income), net             (800 )     517  
Loss before tax             6,398       6,240  
Taxes on income            
-
     
-
 
Total comprehensive and net loss             6,398       6,240  
                         
Net loss per ordinary share, basic and diluted             (0.24 )     (0.38 )
Weighted average number of ordinary shares             26,782,603       16,628,582  

 

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

 

5


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD.

UNAUDITED INTERIM CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

(U.S. dollars in thousands)

 

For the six months ended June 30, 2025:

 

    Ordinary Share Capital              
    Number of shares     Share capital and
Additional Paid in Capital
    Accumulated deficit     Total  
Balance as of January 1, 2025:     24,252,096       70,896       (66,574 )     4,322  
Changes during the six months ended June 30, 2025:                                
Issuance of ordinary shares, pursuant to an at-the-market -facility, net     2,575,753       1,508      
-
      1,508  
Exercise of options     81,633       8      
-
      8  
Restricted share unit vesting     1,083,443      
-
     
-
     
-
 
Share-based compensation             1,838      
-
      1,838  
Exercise of Pre funded warrants     658,372       *      
-
     
-
 
Comprehensive and net loss            
-
      (6,398 )     (6,398 )
Balance as of June 30, 2025     28,651,297       74,250       (72,972 )     1,278  

 

* Less than one thousand

 

For the six months ended June 30, 2024:

 

    Ordinary Share Capital              
    Number of shares     Share capital and
Additional Paid in Capital
    Accumulated deficit     Total  
Balance as of January 1, 2024:     15,652,176       61,259       (55,521 )     5,738  
Changes during the six months ended June 30, 2024:                                
Issuance of ordinary shares and pre-funded warrants, net     2,280,826       4,753      
-
      4,753  
Exercise of options     19,048       2      
-
      2  
Restricted share unit vesting     441,867      
-
     
-
     
-
 
Issuance of ordinary shares- Advisor fees     45,000       62      
-
      62  
Share-based compensation     -       1,028      
-
      1,028  
Comprehensive and net loss     -      
-
      (6,240 )     (6,240 )
Balance as of June 30, 2024     18,438,917       67,104       (61,761 )     5,343  

 

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

 

6


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD.

UNAUDITED INTERIM CONDENSED STATEMENTS OF CASH FLOWS

(U.S. dollars in thousands)

 

    Six months ended
June 30,
2025
    Six months ended
June 30,
2024
 
CASH FLOWS FROM OPERATING ACTIVITIES:                
Net loss     (6,398 )     (6,240 )
Adjustments to reconcile net loss to net cash provided by operating activities:                
Depreciation     73       67  
Capital loss     7       5  
Share based compensation     1,838       1,028  
Evaluation of financial liability at fair value     (689 )     539  
Issuance of ordinary shares - advisor fees    
-
      62  
Prepayments of lease liabilities     (17 )     (6 )
Decrease (increase) in right of use assets     86       (10 )
Decrease (Increase) in other current assets     174       (19 )
(Decrease) increase in trade accounts payable     16       (19 )
(Decrease) increase in other accounts payable     111       112  
(Increase) decrease in inventory     (267 )     (376 )
Unrealized foreign exchange (gain) loss     (21 )     (10 )
Net cash used in operating activities     (5,087 )     (4,867 )
                 
CASH FLOWS FROM INVESTING ACTIVITIES:                
Purchase of property, plant and equipment     (101 )     (2 )
Change in deposits, net     668       (1,388 )
Change in restricted deposits    
-
      1  
Net cash provided by (used in) investing activities     567       (1,389 )
                 
CASH FLOWS FROM FINANCING ACTIVITIES:                
Issuance of ordinary shares and pre-funded warrants, net     *       4,753  
Issuance of ordinary shares pursuant to an at-the-market facility, net     1,511      
-
 
Exercise of options     8       2  
Net cash provided by financing activities     1,519       4,755  
                 
Effect of exchange rate changes on cash and cash equivalents     21       10  
Net decrease in cash and cash equivalents and restricted cash     (3,001 )     (1,501 )
Cash, cash equivalents and restricted cash at the beginning of the period     5,201       5,130  
Cash, cash equivalents and restricted cash at the end of the period     2,221       3,639  

 

* Less than one thousand

 

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

 

7


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD.

UNAUDITED INTERIM CONDENSED STATEMENTS OF CASH FLOWS

(U.S. dollars in thousands)

 

APPENDIX A – RECONCILIATION OF CASH, CASH EQUIVALENTS AND RESTRICTED CASH:

 

    Six months ended
June 30,
2025
    Six months ended
June 30,
2024
 
Cash and cash equivalents     2,126       3,550  
Restricted Cash     95       89  
Total cash, cash equivalents and restricted cash shown in the statement of cash flows     2,221       3,639  

 

APPENDIX B – NON-CASH TRANSACTIONS:

 

    Six months ended
June 30,
2025
    Six months ended
June 30,
2024
 
Share based compensation- placement agent warrants against additional paid in capital (Note 5)    
    -
      254  
                 

 

APPENDIX C - AMOUNT PAID DURING THE PERIOD:

 

    Six months ended
June 30,
2025
    Six months ended
June 30,
2024
 
Interest paid           32            38  

 

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

 

8


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

(U.S. dollars in thousands)

 

NOTE 1 – GENERAL:

 

1. Inspira Technologies Oxy B.H.N. Ltd (the “Company”) was incorporated in Israel and commenced its operations on February 27, 2018. The Company operates in the medical technology industry in the field of respiratory support technology. The Company is engaged in the research, development, and manufacturing-related and go-to-market activities of proprietary products and technologies. The Company is developing the following products:

 

The INSPIRA ART (Augmented Respiratory Technology), a respiratory support technology targeted toward utilizing blood monitoring and direct blood oxygenation to boost patient saturation levels within minutes while the patient is awake. The aim is to provide an alternative to invasive mechanical ventilation, which is associated with high risks, complications, high costs and high mortality rates.

 

The HYLA blood sensor, a non-invasive optical blood sensor designed to perform real-time and continuous blood parameter measurements, potentially reducing the need for intermittent blood samples from patients.

 

The INSPIRA ART100 System, an advanced form of life support system, better known by the medical industry as a cardiopulmonary bypass system, which has been designed for use in procedures requiring cardiopulmonary bypass for six hours or less.

 

The Company’s INSPIRA™ ART100 system received U.S. Food and Drug Administration (“FDA”) 510(k) regulatory clearance for cardiopulmonary bypass procedures and Israeli Medical Equipment Division certification for extra-corporeal membrane oxygenation and cardiopulmonary bypass procedures. The Company’s other products, including the INSPIRA™ ART and HYLA™ blood sensor, have not yet been tested or used in humans and have not been approved by any regulatory entity.

 

2. On March 14, 2025, the Company entered into a sales agreement (the “Sales Agreement”) with A.G.P./Alliance Global Partners, as sales agent, pursuant to which the Company could offer and sell, from time to time, through the sales agent, ordinary shares, no par value, of the Company (“Ordinary Shares”) pursuant to an at-the-market facility (“ATM”), having an aggregate offering price of up to $1,019. On April 10, 2025, the maximum aggregate offering price was increased to $1,917. As of June 30, 2025, the Company has sold 2,575,753 Ordinary Shares under the ATM. The gross proceeds received by the Company from sales through ATM were approximately $1,621, before deducting offering costs of approximately $113. Subsequent to June 30, 2025, the shelf capacity was further increased to $14,686 and the Company issued additional 2,728,889 Ordinary Shares under the ATM facility for gross proceeds of approximately $3,079- see Note 11 (2) and (3).

 

3. The accompanying unaudited interim condensed financial statements (the “Financial Statements”) have been prepared assuming that the Company will continue as a going concern. To date, the Company is at the deployment stage with respect to the INSPIRA ART100, and is in development stage with its other technologies. The Company has suffered recurring losses from operations and negative cash flows from operations since inception. As of June 30, 2025, the Company has incurred accumulated losses of $73 million and expects to continue to fund its operations, in part, through financing, such as the issuance of Ordinary Shares and warrants, in addition to through Israel Innovation Authority (“IIA”) grants. There is no assurance that such financing will be obtained. Our dependency on external funding for our operations raises a substantial doubt about our ability to continue as a going concern. These interim condensed Financial Statements do not include any adjustments that might result from the outcome of these uncertainties. The Company also expects to fund its operations through sales of the Company’s FDA-cleared technology.

 

9


INSPIRA TECHNOLOGIES OXY B.H.N. LTD

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

(U.S. dollars in thousands)

 

NOTE 1 – GENERAL (Cont.): 

 

Our offices are located in Ra’anana, Israel. In October 2023, Hamas terrorists infiltrated Israel’s border with the Gaza Strip and conducted a series of attacks on civilian and military targets. Following the attack, Israel’s security cabinet declared war against Hamas and a military campaign commenced in the Gaza Strip. As of September 1, 2025, the ceasefire with Hamas that had been in place since January 2025 has ended, and hostilities have resumed. Other regional hostilities, since October 7, 2023, have concurrently become more pronounced. This includes and has included a northern front war between Israel and Hezbollah and continued conflict with the Houthi Movement in Yemen. In April 2024 and October 2024, Iran launched direct attacks on Israel involving hundreds of drones and missiles and has threatened to continue to attack Israel. On June 13, 2025, in light of continued nuclear threats and intelligence assessments indicating imminent attacks, Israel launched a preemptive strike directly targeting military and nuclear infrastructure inside Iran aimed to disrupt Iran’s capacity to coordinate or launch further hostilities against Israel, as well as disrupt its nuclear program. For 12 days, both sides launched attacks against one another, with Iran targeting civilian infrastructure. As a result of the escalation with Iran, Israel temporarily closed its airspace and ceased all port activity related to commercial shipments. On June 22, 2024, the U.S. military joined Israel to launch strikes directly targeting nuclear infrastructure in Iran. On June 24, 2025, Israel entered into a ceasefire agreement with Iran, but there are no guarantees as to whether the agreement will hold or whether future hostilities will resume. The company’s operations were not materially impacted by the recent conflicts. 

 

4. 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 an 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.

 

NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES:

 

Basis of preparation

 

The accompanying unaudited interim condensed financial statements have been prepared on the same basis as the annual financial statements. In the opinion of management, the financial statements reflect all normal and recurring adjustments necessary to fairly state the financial position and results of operations of the Company. These interim condensed financial statements should be read in conjunction with the Company’s annual financial statements and accompanying notes, included in the Company’s Annual Report on Form 20-F for the year ended December 31, 2024, as filed with the Securities and Exchange Commission on March 10, 2025, and as amended on March 28, 2025. The year-end balance sheet data was derived from the audited financial statements as of December 31, 2024, but not all disclosures required by generally accepted accounting principles in the United States (“U.S. GAAP”) are included in this interim report.

 

Use of Estimates in the Preparation of Financial Statements

 

The preparation of the Company’s financial statements in conformity with U.S. GAAP requires us to make estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, expenses and related disclosure of contingent assets and liabilities. On an ongoing basis, the Company evaluates its estimates, judgments and methodologies. The Company bases its estimates on historical experience and on various other assumptions that it believes are reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity (including share-based compensation) and the amount of expenses. Actual results could differ from those estimates.

 

10


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

(U.S. dollars in thousands)

 

NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES (Cont.):

 

Impact of new accounting standards

 

In November 2023, the Financial Accounting Standards Board (the “FASB”), issued Accounting Standards Update (the “ASU”), 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. This ASU expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly provided to the CODM and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. All disclosure requirements under ASU 2023-07 are also required for public entities with a single reportable segment. The ASU’s amendments are effective for all public entities for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company has one reportable segment at this stage, and the Company believes that the current disclosures best reflect its operations.

 

Recently Issued Accounting Standards

 

In December 2023, the FASB issued ASU 2023-09, “Improvements to Income Tax Disclosures,” which modifies disclosure requirements for income taxes. This ASU requires the disclosure of the reconciliation between the tabular statutory tax rate and the effective tax rate in both percentages and dollars, additional disaggregated rate reconciliation categories and disaggregation of both income taxes paid and income tax expense by jurisdiction. This guidance is effective for annual periods beginning after December 15, 2024. We expect this ASU to impact only our disclosures, with no impact to our results of operations, cash flows and financial condition.

 

In November 2024, the FASB issued ASU 2024-03, “Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures,” which expands disclosure of significant costs and expenses. This ASU requires expanded disclosures of significant costs and expenditures within cost of goods sold and selling, general and administrative expenses, including amounts of inventory purchased, employee compensation, depreciation, amortization and selling expenses. This ASU also requires expanded qualitative disclosures, including a description of selling expenses and a description of non-disaggregated expenses. This guidance is effective for annual periods beginning after December 15, 2026 and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. We expect this ASU to impact only our disclosures, with no impact to our results of operations, cash flows and financial condition.

 

Revenue recognition

 

The Company’s revenues are measured according to the ASC 606, “Revenue from Contracts with Customers” (“ASC 606”). Under ASC 606, revenues are measured according to the amount of consideration that the Company expects to be entitled to receive in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties.

 

Revenue from product sales is recognized when control of the goods transferred to the customer, which is generally upon shipment, unless contractual terms indicate otherwise.

 

The Company applies the five-step model under ASC 606:

 

(i) identify the contract with a customer;

 

(ii) identify the performance obligations in the contract;

 

(iii) determine the transaction price;

 

(iv) allocate the transaction price to the performance obligations; and

 

(v) recognize revenue when (or as) performance obligations are satisfied.

 

Standard product warranties that provide assurance that the product complies with agreed specifications do not represent a separate performance obligation and are accounted for under ASC 460.

 

11


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

(U.S. dollars in thousands)

 

NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES (Cont.):

 

Determining whether the Company acts as a principal or as an agent in the purchase and sale of machines requires significant judgment. While none of the evaluated factors are independently determinative, after analyzing the guidance under ASC 606 for principal versus agent considerations, the Company concluded that it is acting as an agent in these transactions. As such, revenues are presented on a net basis. This conclusion is based on the contractual relationships involved and the manner in which business is conducted, indicating that the Company does not control the machines before they are transferred to the end customer. In addition, the Company does not bear significant inventory or credit risk.

 

As of June 30, 2025, the company recorded revenues in the amount of $289 from sales of the INSPIRA ART100 systems and carts.

 

Cost of revenues

 

Cost of revenues consists of products purchased from sub-contractors, raw materials, shipping and handling costs to customers, salary, employee-related expenses, depreciation, royalties to the IIA, provision for assurance and overhead expenses.

 

Cost of revenues are expensed commensurate with the recognition of the respective revenues.

 

Government Grants

 

The Company receives royalty-bearing grants from the IIA for approved research and development projects Under Israeli law. Royalties on the revenues derived from products and services developed using such grants, are payable to the Israeli Government.

 

The grants are linked to the exchange rate of the dollar to the New Israeli Shekel and bear interest of the Secured Overnight Financing Rate (“SOFR”) per year (SOFR is a benchmark interest rate which replaced the London Inter-Bank Offered Rate).

 

These grants are recognized as a deduction from research and development costs at the time the Company is entitled to such grants on the basis of the research and development costs incurred. Since the payment of royalties is not probable when the grants are received, the Company records a liability in the amount of the estimated royalties for each individual contract, when the related revenues are recognized, as part of cost of revenues.

 

NOTE 3 – INVENTORY

 

    June 30,
2025
    December 31,
2024
 
Raw materials     219       96  
Work in progress     478       55  
Finished goods (*)     14       293  
Total     711       444  

 

(*) As of June 30, 2025, finished goods inventory includes two completed Inspira ART100 carts ready for sale.

 

NOTE 4 – FINACIAL LIABILITIES AT FAIR MARKET VALUE:

 

    June 30,
2025
    December 31,
2024
 
             
Financial liability (1)     69       69  
Non-tradable warrants (2)     817       1,506  
Total     886       1,575  

 

12


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

(U.S. dollars in thousands)

 

NOTE 4 – FINACIAL LIABILITIES AT FAIR MARKET VALUE (Cont.):

 

1. Financial liability

 

The Company agreed to pay a commission of 4% on proceeds to Dawson James Securities, the exclusive placement agent, received from exercises of 2024 Private Warrants which created a financial liability on the total potential amount, which is $69 as of December 31, 2024.

 

The financial liability fair value as of December 31, 2024 and as of June 30, 2025 is $69.

 

2. Private Warrants

 

On December 26, 2023, the Company entered into a registered direct offering (the “December Purchase Agreement”), pursuant to which it issued unregistered warrants (the “2023 Private Warrants”) to purchase up to an aggregate of 3,031,250 Ordinary Shares at an exercise of $1.28 per share. The 2023 Private Warrants were exercisable immediately upon issuance and will expire three and a half years following their issuance. The 2023 Private Warrants included a cashless exercise mechanism, according to the terms specified in the agreement. The 2023 Private Warrants may create an obligation to transfer cash to the investors at fundamental transactions according to fair value of the Black-Scholes model that includes various inputs. Therefore, the Company accounted for the 2023 Private Warrants as financial liability instruments that are measured at fair value and recognized financial expenses or income through profit and loss.

 

The fair value of the 2023 Private Warrants as of December 31, 2024 and June 30, 2025 was $1,506 and $817 respectively.

 

The key inputs that were used in the 2023 Private Warrants fair value were:

 

    As of
June 30,
2025
    As of
December 31,
2024
 
Stock price     0.85       1.02  
Exercise price     1.28       1.28  
Risk-free interest rate     3.72 %     4 %
Expected volatility     76.83 %     88.61 %
Expected dividend yield     0 %     0 %
Expected term of warrants     2 years       2.5 years  

 

NOTE 5 – REVENUES:

 

As of June 30, 2025, the Company has only one stream of revenue from sales of the INSPIRA ART100 systems and carts to a distributor in the U.S, meaning that the Company has generated revenue in one segment.

 

NOTE 6 – COST OF REVENUES:

 

    As of
June 30,
2025
 
       
Materials and subcontractors     235  
Payroll and related     23  
Warranty     20  
Royalties to IIA     9  
Total     287  

  

13


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

(U.S. dollars in thousands)

 

NOTE 7 – RELATED PARTIES

 

The following transactions arose with related parties:

 

Transactions and balances with related parties:

 

  1. Shareholders and other related parties’ benefits

 

    For the  six-month ended  
    June 30,
2025
    June 30,
2024
 
Salary and related expenses – officers and directors(1)     1,043       881  
Share based payment – officers and directors(2)     1,625       652  

 

(1) The amounts include payroll and related expenses of $118 for a four-month advance notice period, as agreed in the employment agreement of the Company’s former president and director, whose employment was terminated by the board of directors on May 25, 2025.

 

  (2) The amounts include share-based compensation expenses of $672 related to the acceleration of future vesting pursuant to the termination of employment by the Company, and not for cause, as provided under the equity grant agreements of the Company’s former president, founder and director, approved by the Company’s shareholder and board of directors. On November 2025 the RSUs will be technically delivered according to the employment terms.

 

  2. Balances with related parties

 

 

Name     Nature of transaction   As of
June 30,
2025
    As of
December 31,
2024
 
Officers     Salaries and related(1)     (586 )     (381 )
Directors     Compensation for directors     (43 )     (40 )

 

(1) See note 7(1.1)

 

14


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

(U.S. dollars in thousands)

 

NOTE 8 – SHAREHOLDERS’ EQUITY:

 

A. Share capital:

 

1. On April 1, 2024, the Company entered into a purchase agreement with two investors in a registered direct offering (the “April Offering”), whereby the Company sold 1,339,285 Ordinary Shares at a purchase price of $1.232 per share. The aggregate proceeds received by the Company from the April Offering were approximately $1,651.

 

2. On May 20, 2024, the Company issued warrants, to purchase up to 220,000 Ordinary Shares, to a service provider, at an exercise price of $2.25 per share. The Company’s accounting treatment for these warrants as equity-classified instruments (as part of additional paid in capital) is based on an assessment of ASC 718. These warrants were not exercised within the designated timeframe and expired on November 21, 2024.

 

3. On June 14, 2024, the Company entered into a purchase agreement with an individual private investor in a registered direct offering (the “June Offering”), pursuant to which the Company sold (i) an aggregate of 941,541 of the Company’s Ordinary Shares at a purchase price of $1.30 per share, and (ii) pre-funded warrants to purchase up to 1,709,760 Ordinary Shares, at a purchase price of $1.30, less $0.001 per pre-funded warrant (the “June Pre-Funded Warrant”). The aggregate proceeds received by the Company from the June Offering were approximately $3,102, after deducting placement agent commissions and additional offering costs in cash which totaled approximately $343. In addition, the Company issued the placement agent in the June Offering warrants equal to a total of 7.0% of the aggregate number of Ordinary Shares sold in the transaction to purchase up to 185,591Ordinary Shares (the “June Placement Agent Warrants”) at an exercise price of $1.56 per Ordinary Share, which were exercisable immediately upon issuance and which expire four years following their issuance. The Company accounting treatment for the June Placement Agent Warrants as equity-classified instruments (as part of additional paid in capital) is based on an assessment of ASC 718. The fair value of the June Placement Agent Warrants at the issuance date was $254. The cash and non-cash issuance costs were recorded against additional paid in capital, due to the classification of the Ordinary Shares and the June Pre-Funded Warrants as equity in the June Offering.

 

4. On June 30, 2024, the Company issued 45,000 Ordinary Shares to an advisor in connection with consulting service agreement.

 

5. On December 27, 2024, the Company completed its December Private Placement, whereby the Company sold (i) 3,950,343 Ordinary Shares and 2024 Private Warrants to purchase up to 3,950,343 Ordinary Shares at a purchase price of $0.70 per unit, and (ii) pre-funded warrants to purchase up to 658,372 Ordinary Shares (the “2024 Pre-Funded Warrants”) and 2024 Private Warrants to purchase up to 658,372 Ordinary Shares, at a purchase price of $0.70, less $0.001 per unit with a 2024 Pre-Funded Warrant. Each 2024 Pre-Funded Warrant is exercisable for one Ordinary Share at an exercise price of $0.001 per Ordinary Share. Each 2024 Private Warrant is exercisable for one Ordinary Share at an exercise price of $1.10 per Ordinary Share. The 2024 Private Warrants are immediately exercisable and may be exercised at any time until the end of June 2026. The 2024 Pre-Funded Warrants are immediately exercisable and may be exercised at any time until all of the 2024 Pre-Funded Warrants are exercised in full. As of June 30, 2025, all of the 2024 Pre-Funded Warrants were exercised and none of the 2024 Private Warrants were exercised. Subsequent to June 30, 2025, 855,714 2024 Warrants were exercised into Ordinary Shares - see note 11 (1).

 

The Company concluded that the 2024 Private Warrants and 2024 Pre-Funded Warrants are not within the scope of ASC 480. Further, applying ASC 815-40, the Company concluded that the 2024 Private Warrants and 2024 Pre-Funded Warrants are indexed to the Company’s own share capital and meet the conditions for equity classification, and thus should be presented within equity.

 

The gross proceeds received by the Company from the December Private Placement were approximately $3,228, before deducting underwriting discounts and commissions and additional cash offering costs totaled approximately $233. In addition, the Company agreed to pay fees of 4% from the proceeds that may be received in the event of exercise of the 2024 Private Warrants issued in December 2024 Private Placement, issued to certain investors, which created a financial liability. The fair value of the financial liability as of December 31, 2024 and June 30, 2025 is $69 which is the total potential amount to be paid. The cash and non-cash issuance costs were recorded against additional paid in capital.

 

6.

On March 14, 2025, the Company entered into the Sales Agreement, pursuant to which the Company could offer and sell, from time to time, through the sales agent, Ordinary Shares pursuant to an ATM facility, having an aggregate offering price of up to $1,019. On April 10, 2025, the maximum aggregate offering price was increased to $1,917. As of June 30, 2025, the Company has sold 2,575,753 Ordinary Shares under the ATM facility. The gross proceeds received by the Company from sales through the ATM facility were approximately $1,621, before deducting offering costs of approximately $113. Subsequent to June 30, 2025, the shelf capacity was further increased to $14,686 and the Company issued additional 2,728,889 Ordinary Shares under the ATM facility for gross proceeds of approximately $3,079- see Note 11 (2) and (3).

 

15


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

(U.S. dollars in thousands)

 

NOTE 8 – SHAREHOLDERS’ EQUITY (Cont.):

 

7. During the six-month period ending June 30, 2025, the Company issued an aggregate amount of 1,083,443 Ordinary Shares in connection with vested restricted share units, or RSUs, and an additional 81,633 Ordinary Shares in connection with option exercises.

 

B. Warrants reserves - Composition and movements:

 

1. The following table reconciles the movement in warrants outstanding at the beginning and end of the period:

 

    Number of
Warrants
    Weighted-average
exercise price
    Weighted average remaining
contractual term
(in years)
 
Balance as of December 31, 2024     7,728,611       4.14       1.63  
Issued    
-
     
-
     
-
 
Exercised     658,372       0.001      
-
 
Expired    
-
     
-
     
-
 
Balance as of June 30, 2025     7,070,239       4.14       1.14  

 

2. The following table summarizes information about the Company’s outstanding warrants as of June 30, 2025.

 

Exercise Price   Warrants outstanding
as of
June 30,
2025
    Expiration date
5.5     1,640,455     15/07/2026
5.5     277,835     15/07/2025
6.875     145,455     15/01/2027
1.6     212,188     28/06/2027
1.56     185,591     18/06/2028
1.1     4,608,715     30/06/2026
Balance as of June 30, 2025     7,070,239      

 

16


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

(U.S. dollars in thousands)

 

NOTE 8 – SHAREHOLDERS’ EQUITY (Cont.):

 

C. 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
June 30,
2025
    Year ended
June 30,
2024
 
Loss for the period     6,398       6,240  
Total number of Ordinary Shares     28,651,297       18,438,917  
Weighted average number of Ordinary Shares     26,782,603       16,628,582  
Basic and diluted loss per share     (0.24 )     (0.38 )

 

NOTE 9 – SHARE BASED COMPENSATION:

 

In December 2019, the Company established a share option plan (the “Plan”), which was subsequently amended on September 14, 2021 and March 4, 2025. As of June 30, 2025, a total of 767,989 options to purchase Ordinary Shares have been granted to employees, consultants and directors under the Plan, of which 610,134 options are fully vested as of June 30, 2025, and a total of 9,398,542 RSUs have been granted to employees, consultants and directors under the Plan, of which 4,800,640 RSUs are fully vested as of June 30, 2025, some of which were exercised during the period since the Company’s inception.

 

On January 22, 2024, the Company’s board of directors approved a grant of 320,000 RSUs to employees and a grant of options to purchase 80,000 shares to consultants. The RSUs represents the right to receive Ordinary Shares at a future time, 245,000 of which vest over a period of three years, with a one-year cliff period and 70,000 vesting immediately on the grant date. 10,000 options were vested immediately on

the grant date, 25,000 options vest over a period of three years and 45,000 options vest over a period of one

year and nine months. The RSUs designated to employees were granted under Section 102 of the Israeli Tax Ordinance, which enables the employee to pay a 25% capital gain tax upon exercise.

 

On February 5, 2024, the Company’s board of directors approved a grant of 2,277,000 RSUs to officers, a grant of options to purchase 30,000 Ordinary Shares and 90,000 RSUs to directors. The RSUs and options represent the right to receive Ordinary Shares at a future time and vest over a period of three years, with a one-year cliff. The RSUs designated to employees and directors were granted under Section 102 of the Israeli Tax Ordinance, which enables the employee to pay a 25% capital gain tax upon exercise.

 

On February 22, 2025, the Company’s board of directors approved a grant of 644,000 RSUs to employees and a grant of options to purchase 55,000 Ordinary Shares to consultants. The RSUs represent the right to receive Ordinary Shares at a future time. All the RSUs in this grant, vest over a period of three years, with a one-year cliff period. The RSUs designated to employees were granted under Section 102 of the Israeli Tax Ordinance, which enables the employee to pay a 25% capital gain tax upon exercise. An amount of 30,000 of the options vest over a period of one year and 25,000 options vest over a period of three years with a one-year cliff period.

 

On February 22, 2025, the Company’s board of directors approved a grant of 2,150,000 RSUs to officers, and 210,000 RSUs to directors. The RSUs represent the right to receive Ordinary Shares at a future time and vest over a period of three years, with a one-year cliff. The RSUs designated to employees and directors were granted under Section 102 of the Israeli Tax Ordinance, which enables the employee to pay a 25% capital gain tax upon exercise.

 

17


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

(U.S. dollars in thousands)

 

NOTE 9 – SHARE BASED COMPENSATION (Cont.):

 

The fair market value of all granted options was estimated by using the Black-Scholes model, aimed at modelling 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:

 

The valuation was completed by the company based on the following assumptions:

 

(i) Risk-free interest rate 4.19%

 

(ii) The expected volatility is 128.78%;

 

(iii) The dividend rate 0%; and

 

(iv) Expected term – 0-3 years.

 

During the six months ended June 30, 2025, the Company recorded share-based payment expenses in the amount of $1,838.

 

The options to service providers and advisers outstanding as of June 30, 2025, as follows:

 

    Six months ended
June 30, 2025
 
    Number of options     Weighted Average Exercise
Price (in NIS)
 
             
Outstanding at beginning of year     185,111       3.36  
Granted    
-
     
 
 
Exercised     55,000       3.40  
Forfeited    
 
     
 
 
Outstanding as of June 30, 2025     240,111       3.37  
Exercisable options     182,812       3.34  
Share-based payment expenses     26          

 

The number of the outstanding vested RSUs to services providers and advisors as of June 30, 2025, were 32,500.

 

The options to employees and directors outstanding as of June 30, 2025, as follows:

 

    Six months ended
June 30, 2025
 
    Number of options     Weighted average Exercise
price NIS
 
             
Outstanding at beginning of year     368,641       0.37  
Granted     -          
Exercised     81,633       0.37  
Forfeited     30,000       3.56  
Outstanding as of June 30, 2025     257,008       0.48  
Exercisable options as of June 30, 2025     257,008       0.48  
Share-based payment expenses     (15 )        

 

18


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

(U.S. dollars in thousands)

 

NOTE 9 – SHARE BASED COMPENSATION (Cont.):

 

The RSUs to employees and directors outstanding as of June 30, 2025, as follows:

 

    Number of RSUs  
       
Outstanding at beginning of year     2,518,796  
Granted     3,004,000  
Forfeited     37,835  
Vested(1)     1,083,443  
Outstanding as of June 30, 2025     4,401,518  
Vested as of June 30, 2025     4,768,140  
Share-based payment expenses(1)     1,827  

 

(1)

The share amount does not include the vesting event due to take place at the end of November 2025 of 1,313,333 shares, related to the acceleration of future vesting pursuant to the termination of employment by the Company, and not for cause.

 

(2) The expenses amount includes share-based compensation expenses related to acceleration of future vesting per termination of employment by the company and not for cause, as provided under the equity grant agreements and approved by the Company’s shareholder and board of directors. The acceleration is due to take place at the end of November 2025.

 

NOTE 10 – COMMITMENTS AND CONTINGENCIES:

 

A. Royalties to the IIA

 

In September 2019, the IIA approved an application that supports upgrading the Company’s manufacturing capabilities for an aggregate budget of NIS 4,880,603 (approximately $1,500,000). The IIA committed to fund 60% of the approved budget. Eventually the project budget concluded in the aggregate amount of NIS 4,623,142 (approximately $1,333). The program is for the period beginning October 2019 through November 2020 and the Company received total funds in the amount of NIS 2,773,885 (approximately $809) from the IIA, which were recorded as part of the IIA participation and were deducted from research and development (“R&D”) expenses.

 

In October 2023, the IIA approved a support of another development project of the Company at an aggregate budget of NIS 3,850,869 (approximately $1,062). The IIA committed to fund 40% of the approved budget. The program is for the period beginning January 2024 through March 2025, and as of June 30, 2025, the Company received total funds in the amount of NIS 1,300,171 (approximately $351) from the IIA, which were recorded as part of the IIA participation and were deducted from the R&D expenses.

 

According to the agreements with the IIA, the Company will pay royalties of 3% of sales up to an amount equal to the accumulated grant received linked to the U.S. dollar and bearing interest at an annual rate of SOFR. Repayment of the grants are contingent upon the successful completion of the Company’s R&D programs and generating sales. The Company has no obligation to repay these grants if the R&D programs fail, are unsuccessful or aborted, or if no sales are generated.

 

19


 

INSPIRA TECHNOLOGIES OXY B.H.N. LTD

NOTES TO THE UNAUDITED INTERIM CONDENSED FINANCIAL STATEMENTS

(U.S. dollars in thousands)

 

NOTE 10 – COMMITMENTS AND CONTINGENCIES (Cont.):

 

The Company has generated sales as of June 30, 2025; therefore, a liability in the amount of $9 was recorded against cost of sales expenses. As of June 30, 2025, the maximum obligation with respect to the grants received from the IIA, contingent upon entitled future sales, is $1,161 plus SOFR interest.

 

The Company has obligations regarding know-how, technology, or products, not to transfer the information, rights thereon and production rights which derive from the research and development without the IIA Research Committee approval.

 

B. Legal Claims

 

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 six month period ended June 30, 2025.

 

On December 12, 2021, the Company terminated its employment agreement with Dr. Udi Nussinovitch, one of its founders who served as the Company’s Chief Scientific Officer since March 2018. On February 24, 2022, the Company sued Mr. Nussinovitch for breach of good faith and breach of his fiduciary duties as a shareholder and former officer of the Company. On November 9, 2022, the Company received notice of a complaint filed by Mr. Nussinovitch, as well as a complaint filed with the regional labor court in Tel Aviv, Israel on November 8, 2022. Mr. 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. A partial hearing was held in the regional labor court on July 19, 2023, and the parties were required by the court to file their positions on a stay of the proceeding pending the decision on the case initiated by the plaintiff in the District Court.

 

A pre-trial hearing was held in the district court on January 21, 2024. During the hearing, the court suggested that the parties consider resolving the case through an out-of-court arrangement or mediation. The parties agreed to a mediation process which did not succeed. On January 7, 2025, Mr. Nussinovitch filed a motion to amend his Statement of Claim, requesting to modify the requested relief. Instead of the original remedies sought, Mr. Nussinovitch requested that the Company, or Mr. Ben Noon and Mr. Hayon, purchase all of his rights and shares in the Company at their average value from the date of the Company’s initial public offering until the date of the general meeting held on December 17, 2021. On January 13, 2025, a pretrial hearing was held. The court denied Mr. Nussinovitch’s motion to amend and instructed him to notify whether he wishes to withdraw his original claim or maintain it. Mr. Nussinovitch’s notified the court that he intended to proceed with the original claim in its current form. On May 7, 2025, the court issued its decision on the motion to dismiss. The judge ruled that the claim would be partially dismissed and that the continuation of the proceedings would be contingent upon payment of court fees. The court ordered the dismissal of remedies that Mr. Nussinovitch’s himself had clarified were no longer relevant and further determined that the declaratory remedies would remain in the claim and ruled that Mr. Nussinuvich must pay court fees in connection with the operative remedy regarding Mr. Nussinovich’s entitlement to receive the benefits granted to the controlling shareholders and the allocation of restricted shares. On June 26, 2025, Mr. Nussinovich submitted a notice to the court detailing the calculation of the claim value in relation to the operative remedies.

 

According to Mr. Nussinovich’s calculations, the value of the restricted shares he was entitled to receive amounts to NIS 5,751,714. Based on this valuation, Mr. Nussinovich paid court fees in the amount of NIS 143,493.A preliminary hearing in the case was held on September 8, 2025, during which the court set deadlines for the filing of witness statements. On September 18, 2025, Mr. Nussinovich notified the court of his consent to dismiss the claim against the directors of the Company. On September 21, 2025, the court rendered a judgment dismissing the claim against the Company’s directors.

 

As of the date of these Financial Statements, the Company believes that the claims will result in no disbursement of monetary payments by the Company.

 

NOTE 11 – SUBSEQUENT EVENTS:

 

1. In July 2025, a total of 855,714 2024 Private Warrants were exercised by several investors, resulting in aggregate exercise proceeds of $941. Pursuant to its agreement, the Company paid Dawson James Securities a total of $23, commission in connection with warrant exercise.

 

2. On July 1, 2025, the shelf capacity was increased, resulting in the Company increasing the maximum ATM facility capacity to $7,118.

 

3.

On September 16, 2025, the shelf capacity was increased, resulting in the Company increasing the maximum ATM facility capacity to $14,686, of which total of $4,701 has been sold as of the date of these Financial Statements.

 

4. On July 2, 2025, the Company received a binding purchase order in the amount of $22.5 million for its FDA-cleared INSPIRA ART100 system and carts. On August 19, 2025, the Company received another binding purchase order for its INSPIRA ART100 systems, in the amount of $27 million.
   
5. On August 6, 2025, the Company’s board of directors approved a grant of 1,200,000 RSUs to officers. The RSUs and options represent the right to receive Ordinary Shares at a future time and vest over a period of three years, with a half-year cliff. The Company’s board of directors approved a future grant of 300,000 RSUs to officers depending on achieving a revenue-based milestone.
   
6. On August 6, 2025, the Company’s board of directors approved the issuance of 100,000 Ordinary Shares to a service provider as equity compensation for his investor relations and press release services, in lieu of a cash payment.

 

20

 

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EX-99.3 4 ea025460401ex99-3_inspira.htm INSPIRA TECHNOLOGIES OXY B.H.N. LTD.'S MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION FOR THE SIX MONTHS ENDED JUNE 30, 2025

Exhibit 99.3

 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION

AND RESULTS OF OPERATIONS

 

Cautionary Statement Regarding Forward-Looking Statements

 

Certain information included herein may be deemed to be “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Forward-looking statements are often characterized by the use of forward-looking terminology such as “may,” “will,” “expect,” “anticipate,” “estimate,” “continue,” “believe,” “should,” “intend,” “project” or other similar words, but are not the only way these statements are identified.

 

These forward-looking statements may include, but are not limited to, statements relating to our objectives, plans and strategies, statements that contain projections of results of operations or of financial condition, expected capital needs and expenses, statements relating to the research, development, completion and use of our products, and all statements (other than statements of historical facts) that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future.

 

Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. We have based these forward-looking statements on assumptions and assessments made by our management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.

 

Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among other things:

 

  our expectation regarding the sufficiency of our existing cash and cash equivalents to fund our current operations;
     
  our financial statements for the period ended June 30, 2025, contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern, which could prevent us from obtaining new financing on reasonable terms, if at all;
     
  our ability to advance the development of our products and future potential products;
     
  our ability to commercialize and sell our products and future potential products and future sales of our product or any other future potential products;
     
 

our assessment of the potential of our products and future potential product candidates to treat certain indications;

     
 

our available cash and our ability to obtain additional funding;

     
  our planned level of revenues, capital expenditures and liquidity;
     
  our plans to continue to invest in research and development to develop technology for new products;
     
  anticipated actions of the U.S. Food and Drug Administration, or FDA, state regulators, if any, or other similar foreign regulatory agencies, including approval to conduct clinical trials, the timing and scope of those trials and the prospects for regulatory approval or clearance of, or other regulatory action with respect to our products or services;
     
  the regulatory environment and changes in the health policies and regimes in the countries in which we intend to operate, including the impact of any changes in regulation and legislation that could affect the medical device industry;

 


 

  our ability to meet our expectations regarding the commercial supply of our products and future product candidates;
     
  our ability to retain key executive members;
     
  our ability to internally develop new inventions and intellectual property;
     
  the overall global economic environment;
     
  the impact of competition and new technologies;
     
  general market, political and economic conditions in the countries in which we operate;
     
  ● 

the possible impacts of cybersecurity incidents on our business and operations;

     
  our ability to internally develop new inventions and intellectual property;
     
  changes in our strategy; and
     
  litigation.

 

These statements are only current predictions and are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. For a more detailed description of the risks and uncertainties affecting us, reference is made to our annual report on Form 20-F for the fiscal year ended December 31, 2024, which we filed with the Securities and Exchange Commission, or the SEC, on March 10, 2025, and amended on March 28, 2025, or the Annual Report, and the other risk factors discussed from time to time by us in reports filed or furnished to the SEC.

 

Except as required by law, we are under no duty to update or revise any of the forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this prospectus.

 

Unless otherwise indicated, all references to “we,” “us,” “our,” the “Company” and “Inspira” refer to Inspira Technologies Oxy B.H.N. Ltd. References to “NIS” are to New Israeli Shekels and references to “dollars” or “$” are to U.S. dollars. We prepare and report our financial statements in accordance with generally accepted accounting principles in the United States. 

 

A. Operating Results

 

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited condensed financial statements and the related notes thereto for the six months ended June 30, 2025, included elsewhere in this Report of Foreign Private Issuer on Form 6-K. The discussion below contains forward-looking statements that are based upon our current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from these expectations due to inaccurate assumptions and known or unknown risks and uncertainties.

 

Overview

 

Since our inception in 2018, we have incurred operating losses. Our operating losses for the six-months ended June 30, 2025 and 2024 were $7.2 million and $5.8 million, respectively, and our net losses for the same period were $6.4 million and $6.2 million, respectively. As of June 30, 2025, we had an accumulated deficit of $73 million. We expect to continue to incur expenses and operating losses for the foreseeable future, and our losses may fluctuate significantly from year to year. We anticipate that our expenses will increase significantly in connection with our ongoing activities, as we:

 

  continue clinical development of our products;
     
  file applications seeking regulatory approval for our products pursuant to the various regulatory pathways in the United States;

 

2


 

  continue to invest in the preclinical research and development of any future product candidates;
     
 

 

continue to establish the commercial infrastructure to support the marketing, sale and distribution of our FDA- cleared product and additional products, should they receive regulatory approval in the future;

     
  expand our sales and marketing efforts of our FDA-cleared product and in preparation for potential commercialization of future products upon regulatory approval;
     
  hire additional research and development and general and administrative personnel to support our operations;
     
  maintain, expand and protect our intellectual property portfolio; and
     
  continue to incur costs associated with operating as a public company.

 

Current Outlook

 

We have incurred losses and generated negative cash flows from operations since inception in 2018.

 

As of June 30, 2025, our cash and cash equivalents and deposits were $2.1 million.

 

On March 14, 2025, we entered into a sales agreement with A.G.P./Alliance Global Partners, or AGP, as sales agent, pursuant to which we may offer and sell, from time to time, through the sales agent, ordinary shares, no par value, or the Ordinary Shares, of the Company, or the ATM Facility, having an aggregate offering price of up to $1,019,000. On April 10, 2025, the maximum aggregate offering price was increased to $1,917,052, on July 1, 2025, the maximum aggregate offering price increased to $7,117,720 and on September 16, 2025, the maximum aggregate offering price increased to $14,686,641. As of June 30, 2025, we sold an aggregate of 2,575,753 Ordinary Shares for an aggregate offering amount of $1,621,892, before deducting offering costs of approximately $113.

 

Since January 1, 2025, and as of June 30, 2025, the Company has issued an aggregate amount of 1,083,443 Ordinary Shares in connection with vested restricted share units, or RSUs, and an additional 81,633 Ordinary Shares in connection with option exercises.

 

We expect that our existing cash and cash equivalents as of June 30, 2025, in addition to proceeds expected to be raised through sales of Ordinary Shares through the At-the-Market Facility, and additional proceeds we may raise by sale of Ordinary Shares and warrants, in addition to income from sale of our product, will enable us to fund our operating expenses and capital expenditure requirements for the next twelve months. Since there is no assurance that such financing will be obtained, our dependence on external funding for our operations raises a substantial doubt about our ability to continue as a going concern.

 

Our operating plans may change as a result of many factors that may currently be unknown to us, and we may need to seek additional funds sooner than planned. Our future capital requirements will depend on many factors, including:

 

  the progress and costs of our research and development activities;
     
  the costs of manufacturing and selling our products;
     
 

the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;

     
  the ability to commercialize our products;

 

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  the potential costs of contracting with third parties to provide marketing and distribution services for us or for building such capacities internally; and
     
  the magnitude of our general and administrative expenses.

 

We expect to satisfy our future cash needs through generating revenue with product sales and through equity financings. We cannot be certain that we will be successful in commercializing our products in development, the marketing and sales of our FDA-approved product, or that additional funding will be available to us on acceptable terms, if at all. This raises substantial doubts about our ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. If funds are not available, we may be required to delay, reduce the scope of, or eliminate research or development plans for, or commercialization efforts with respect to our product candidates.

 

Quantitative and Qualitative Disclosures about Market Risk

 

Foreign Currency Exchange Risk

 

We operate primarily in Israel and approximately 70% of our expenses are denominated in NIS. We are therefore exposed to market risk, which represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates. We are subject to fluctuations in foreign currency rates in connection with these arrangements.

  

Interest Rate Risk

 

We do not anticipate undertaking any significant long-term borrowing. At present, our investments consist primarily of cash and cash equivalents and short-term deposits. The primary objective of our investment activities is to preserve the principal while maximizing the income that we receive from our investments without significantly increasing risk and loss. Our investments may be exposed to market risk due to fluctuation in interest rates, which may affect our interest income and the fair market value of our investments, if any.

 

Impact of Inflation and Currency Fluctuations

 

Inflation generally affects us by increasing our NIS-denominated expenses, including salaries and benefits, as well as facility rental costs and payment to local suppliers. We do not believe that inflation had a material effect on our business, financial condition or results of operations during the six months ended June 30, 2025. 

 

Components of Operating Expenses

 

Our current operating expenses consist of four components —cost of revenue, research and development expenses, general and administrative expenses and marketing expenses.

 

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited interim condensed consolidated financial statements and the related notes thereto for the six months ended June 30, 2025, included elsewhere in this Report of Foreign Private Issuer on Form 6-K. The discussion below contains forward-looking statements that are based upon our current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from these expectations due to inaccurate assumptions and known or unknown risks and uncertainties.

 

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Revenues

 

We recognized revenue for the first time since our inception, in the amount of $289 for the six months ended June 30, 2025.

 

Our revenues solely consist of sales of our INSPIRA ART100 systems and carts.

 

Cost of Revenues

 

Our cost of revenues consists primarily of the cost of the production of our products, including sub-contractors, raw materials, testing, quality assurance, shipping and handling costs to customers, royalties to the Israel Innovation Authority, or IIA, provisions for assurance, and direct overheads, such as salary and employee related expenses.

 

The total cost of revenue for the period of six months ended June 30, 2025 was $287.

 

Operating Expenses

 

Our current operating expenses consist of four components —cost of revenue, research and development expenses, sales and marketing expenses and general and administrative expenses.

 

Research and Development Expenses, net

 

Our research and development expenses consist primarily of salaries and related personnel expenses, share-based compensation expenses, materials costs consultants and other third parties who support the development of our product service fees, and other related research and development expenses.

 

In September 2019, we received the approval of the IIA to fund 60% of certain project development expenses, the total budget of which is 1,500, within the framework of a fixed budget and time period. In October 2023, the IIA approved funding for another development project with a budget of NIS 3,850,869 (approximately $1,062 thousand) and committed to funding 40% of such approved budget. Approximately $351 thousand has been received as of June 30, 2025.

 

The following table discloses the breakdown of research and development expenses:

 

Unaudited   Six Months Ended
June 30,
U.S. dollars in thousands   2025   2024
         
Salary and related expenses     2,358       2,019  
Materials and related expenses     377       113  
Subcontractors     90       172  
Professional services     53       233  
IIA participation     (66 )     -  
Share-based compensation     512       495  
Depreciation     171       166  
Other     143       72  
Total   $ 3,638     $ 3,270  

 

We expect that our research and development expenses will increase as we continue to develop our products and as we continue to make all necessary product-related regulatory filings and clinical processes.

 

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General and Administrative Expenses

 

General and administrative expenses consist primarily of salaries and related expenses, share-based compensation, professional service fees for accounting and booking, legal fees, facilities, travel expenses and other general and administrative expenses.

 

The following table shows the breakdown of general and administrative expenses:

 

Unaudited   Six Months Ended
June 30,
U.S. dollars in thousands   2025   2024
         
Professional fees     1,042       970  
Share-based compensation     1,144       363  
Director’s fees and share-based compensation     92       119  
Salary and related expenses     578       404  
Insurance expenses     89       107  
Depreciation     64       56  
Rent and office maintenance     66       63  
Travel abroad     34       45  
Others     41       55  
Total   $ 3,150     $ 2,182  

 

Comparison of the Six Months Ended June 30, 2025 and 2024

 

Results of Operations

 

    Six Months Ended
June 30,
U.S. dollars in thousands   2025   2024
     
Revenues     289       -  
Cost of Revenues     287       -  
Research and development expenses     3,638       3,270  
Sales and marketing expenses     442       349  
General and administrative expenses     3,150       2,182  
Other expenses (income)     7       5  
Operating loss     7,235       5,806  
Interest income from deposits     (37 )     (83 )
Financial expenses (income)     (800 )     517  
Total comprehensive net loss   $ 6,398     $ 6,240  

 

Revenues

 

Our revenues for the six months ended June 30, 2025 were $289 thousand, compared to zero for the six months ended June 30, 2024.

 

Cost of Revenues

 

Our cost of revenues for the six months ended June 30, 2025 were $287 thousand, compared to zero for the six months ended June 30, 2024

 

Research and Development Expenses

 

Research and development expenses for the six months ended June 30, 2025, were $3,638 thousand compared to $3,270 thousand for the six months ended June 30, 2024. The increase is attributable mainly to the increase in personnel and salaries, exchange rate differences between NIS and USD, and an increase in share-based compensation.

 

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Sales and marketing expenses

 

Sales and marketing expenses for the six months ended June 30, 2025, were $442 thousand compared to $349 thousand for the six months ended June 30, 2024. The increase is attributable to the increase in share-based compensation expenses and commercialization expenses.

 

General and administrative expenses

 

General and administrative expenses for the six months ended June 30, 2025, were $3,150 thousand compared to $2,182 thousand for the six months ended June 30, 2024. The increase is primarily attributable to share based compensation expenses related to (i) the accelerated vesting of our former president’s options and RSUs, and (ii) salary expenses as part of our former president’s termination package, pursuant to his employment agreement. The increase is also attributable to a general increase in salaries, in part due to exchange rate fluctuations and in part due to other officer and employee share-based compensation expenses.

 

Operating loss

 

As a result of the foregoing, our operating loss for the six months ended June 30, 2025 was $7,235 thousand compared to an operating loss of $5,806 thousand for the six months ended June 30, 2024, an increase of $1,429 thousand, or 25%.

 

Financial expenses

 

We recognized financial income for the six months ended June 30, 2025 of $800 thousand compared to financial expenses of $517 thousand for the six months ended June 30, 2024. The difference is mainly due to a change in the fair value of financial liability.

 

Total comprehensive loss

 

As a result of the foregoing, our total comprehensive loss for the six months ended June 30, 2025 was $6,398 thousand compared to $6,240 thousand for the six months ended June 30, 2024, an increase of $158 thousand, or 3%.

 

Critical Accounting Estimates

 

The preparation of financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting periods. A comprehensive discussion of our critical accounting policies is included in “Critical Accounting Estimates” under “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section in our Annual Report, as well as our unaudited condensed financial statements and the related notes thereto for the six months ended June 30, 2025, included elsewhere in this Report of Foreign Private Issuer on Form 6-K.

 

B. Liquidity and Capital Resources

 

Overview

 

Since our inception through June 30, 2025, we have funded our operations principally from the proceeds of our IPO, the sale of convertible securities, the proceeds from the exercise of warrants, government grants and sale of Ordinary Shares. To date, the Company is at the deployment stage with respect to the INSPIRA ART100, and is in development stage with its other technologies. The Company has suffered recurring losses from operations and negative cash flows from operations since inception. As of June 30, 2025, the Company has incurred accumulated losses of $73 million and expects to continue to fund its operations, in part, through financing, such as the issuance of Ordinary Shares and warrants, in addition to through IIA grants. There is no assurance that such financing will be obtained. Our dependency on external funding for our operations raises a substantial doubt about our ability to continue as a going concern. The Financial Statements do not include any adjustments that might result from the outcome of these uncertainties. The Company also expects to fund its operations through sales of the Company’s FDA-cleared technology.

 

Our management intends to raise additional funds through offerings of our securities that will be utilized to fund product development and continue operations and marketing. We do not have any material financial obligations as of June 30, 2025. We believe that the proceeds from any future financings, combined with our cash on hand, are sufficient to meet our obligations for the next six months. There are no assurances, however, that the Company will be able to obtain an adequate level of financial resources that are required for the long-term development and commercialization of its product offering.

 

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As of June 30, 2025, we had $2.1 million in cash, cash equivalents and cash deposits.

 

The table below presents our cash flows for the periods indicated:

 

    Six Months Ended
June 30,
U.S. dollars in thousands   2025   2024
         
Net cash used in operating activities     (5,087 )     (4,867 )
                 
Net cash provided (used) in investing activities     567       (1,389 )
                 
Net cash provided by financing activities     1,519       4,755  
                 
Effect of exchange rate changes on cash and cash equivalents     21       10  
                 
Net decrease in cash and cash equivalents     (3,001 )     (1,501 )

 

Operating Activities

 

Net cash used in operating activities of $5,087 thousand during the six months ended June 30, 2025 and net cash used in operating activities of $4,867 thousand during the six months ended June 30, 2024 were primarily used for the payment of salaries and related personnel expenses, materials expenses, subcontractors, travel and office maintenance.

 

Income due to changes in the fair market value of financial liabilities for the six months ended June 30, 2025 was $689 thousand, compared to expenses of $539 thousand for the six months ended June 30, 2024.

 

Investing Activities

 

Net cash provided in investing activities of $567 thousand during the six months ended June 30, 2025 consisted mainly of the change in cash deposits and the effect of the exchange rate on it in the amount of $668 thousand. Net cash used in investing activities of $1,389 thousand during the six months ended June 30, 2024, consisted mainly of the change in deposits and the effect of the exchange rate on it in the amount of $1,388 thousand.

 

Financing Activities

 

Net cash provided by financing activities of $1,519 thousand during the six months ended June 30, 2025 consisted primarily of proceeds from the sale of Ordinary Shares through the At-the-Market Facility.

 

Net cash provided by financing activities of $4,755 thousand during the six months ended June 30, 2024 consisted primarily of fundraising.

 

On April 1, 2024, the Company entered into a purchase agreement with two investors in a registered direct offering, or the April Offering, pursuant to which the Company issued an aggregate of 1,339,285 Ordinary Shares at a purchase price of $1.232 per share. The aggregate proceeds received by the Company from the April Offering were approximately $1.65 million.

 

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On June 14, 2024, we entered into a purchase agreement with a single, individual investor, providing for the issuance in a registered direct offering, or the June Offering, of (i) an aggregate of 941,541 Ordinary Shares, at a purchase price of $1.30 per share, and (ii) pre-funded warrants to purchase up to 1,709,760 Ordinary Shares, at a purchase price of $1.30, less $0.001 per pre-funded warrant. Each pre-funded warrant is exercisable for one Ordinary Share at an exercise price of $0.001 per share. The pre-funded warrants are immediately exercisable and may be exercised at any time until all of the pre-funded warrants are exercised in full. The June Offering resulted in gross proceeds of $3.4 million. We issued placement agent in the agreement warrants equal to a total of 7.0% of the aggregate number of Ordinary Shares sold in the transaction and 185,591 warrants to purchase up to 185,591 Ordinary Shares with an exercise price of $1.56 per share. The placement agent warrants were exercisable immediately upon issuance and expire four years following issuance.

 

On December 27, 2024, we entered into securities purchase agreements for private placement financing with certain accredited investors, or the December Private Placement, pursuant to which the investors agreed to purchase (i) 3,950,343 of our Ordinary Shares at a purchase price of $0.70 per share, (ii) pre-funded warrants to purchase up to 658,372 Ordinary Shares at a purchase price of $0.70, less $0.001 per pre-funded warrant. In addition, the purchasers of such Ordinary Shares or pre-funded warrants received warrants to purchase up to 4,608,715 Ordinary Shares at an exercise price of $1.10 per share. We received approximately $3.2 million in gross proceeds. In addition, we entered into a placement agency agreement with Dawson James Securities, Inc., who served as placement agent in the offering, dated December 27, 2024, pursuant to which we agreed to pay the placement agent a cash placement fee equal to: (a) 8.0% of the gross proceeds received in the offering from certain investors introduced by the placement agent and 4.0% of the gross proceeds received by us from the exercise of warrants by such investors, (b) 4.0% of the gross proceeds received in the offering from certain investors introduced by us and 4.0% of the gross proceeds received by us from the exercise of warrants by such investors, and (c) 0% of the gross proceeds received in the offering from certain other investors and 0% of the gross proceeds received by us from the exercise of warrants by such investors.

 

On March 14, 2025, we entered into a sales agreement with AGP as sales agent, pursuant to which we may offer and sell, from time to time, under the ATM Facility, Ordinary Shares having an aggregate offering price of up to $1,019,000. On April 10, 2025, the maximum aggregate offering price was increased to $1,917,052, on July 1, 2025, the maximum aggregate offering price increased to $7,117,720 and on September 16, 2025, the maximum aggregate offering price increased to $14,686,641. As of June 30, 2025, we sold an aggregate of 2,575,753 Ordinary Shares for an aggregate offering amount of approximately $1.6 million.

 

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