QTREX Quantum Ltd 6-K, filed Oct 1, 2025
QTREX Quantum Ltd. (QTEX)
About this 6-K
QTREX Quantum Ltd filed this 6-K on October 1, 2025.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
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
Commission File Number:
(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
CONTENTS
This Report of Foreign Private Issuer on Form 6-K consists of Inspira Technologies Oxy B.H.N. 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and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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). |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
| Inspira Technologies Oxy B.H.N. Ltd. | |||
| Date: October 1, 2025 | By: | /s/ Dagi Ben-Noon | |
| Name: | Dagi Ben-Noon | ||
| Title: | Chief Executive Officer | ||
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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. |
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| ● | 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
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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 | ||||||
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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 | ||||||
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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
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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
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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 | ||||||||||
| Deposits | ||||||||||
| Other current assets | ||||||||||
| Inventory | 3 | |||||||||
| Total current assets | ||||||||||
| Non-Current Assets: | ||||||||||
| Right of use assets, net | ||||||||||
| Property, plant and equipment, net | ||||||||||
| Total non-current assets | ||||||||||
| Total Assets | ||||||||||
The accompanying notes are an integral part of the financial statements.
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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 | ||||||||||
| Other accounts payable | ||||||||||
| Lease liabilities | ||||||||||
| Financial liabilities at fair market value | 4 | |||||||||
| Total current liabilities | ||||||||||
| Non-Current Liabilities: | ||||||||||
| Lease liabilities | ||||||||||
| Total non- current liabilities | ||||||||||
| Shareholders' Equity: | ||||||||||
| Ordinary shares, par value: Authorized | ||||||||||
| Share capital and additional paid-in capital | 8 | |||||||||
| Accumulated losses | ( | ) | ( | ) | ||||||
| Total Shareholders' Equity | ||||||||||
| Total Liabilities and Shareholders' Equity | ||||||||||
The accompanying notes are an integral part of the financial statements.
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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 | |||||||||||
| Cost of revenues | 6 | |||||||||||
| Gross Profit | ||||||||||||
| Research and development expenses | ||||||||||||
| General and administrative expenses | ||||||||||||
| Sales and marketing expenses | ||||||||||||
| Other expenses | ||||||||||||
| Operating loss | ||||||||||||
| Interest income from deposits | ( | ) | ( | ) | ||||||||
| Finance expenses (income), net | ( | ) | ||||||||||
| Loss before tax | ||||||||||||
| Taxes on income | ||||||||||||
| Total comprehensive and net loss | ||||||||||||
| Net loss per ordinary share, basic and diluted | ( | ) | ( | ) | ||||||||
| Weighted average number of ordinary shares | ||||||||||||
The accompanying notes are an integral part of the financial statements.
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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: | ( | ) | ||||||||||||||
| Changes during the six months ended June 30, 2025: | ||||||||||||||||
| Issuance of ordinary shares, pursuant to an at-the-market -facility, net | ||||||||||||||||
| Exercise of options | ||||||||||||||||
| Restricted share unit vesting | ||||||||||||||||
| Share-based compensation | ||||||||||||||||
| Exercise of Pre funded warrants | ||||||||||||||||
| Comprehensive and net loss | ( | ) | ( | ) | ||||||||||||
| Balance as of June 30, 2025 | ( | ) | ||||||||||||||
| * |
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: | ( | ) | ||||||||||||||
| Changes during the six months ended June 30, 2024: | ||||||||||||||||
| Issuance of ordinary shares and pre-funded warrants, net | ||||||||||||||||
| Exercise of options | ||||||||||||||||
| Restricted share unit vesting | ||||||||||||||||
| Issuance of ordinary shares- Advisor fees | ||||||||||||||||
| Share-based compensation | - | |||||||||||||||
| Comprehensive and net loss | - | ( | ) | ( | ) | |||||||||||
| Balance as of June 30, 2024 | ( | ) | ||||||||||||||
The accompanying notes are an integral part of the financial statements.
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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 | ( | ) | ( | ) | ||||
| Adjustments to reconcile net loss to net cash provided by operating activities: | ||||||||
| Depreciation | ||||||||
| Capital loss | ||||||||
| Share based compensation | ||||||||
| Evaluation of financial liability at fair value | ( | ) | ||||||
| Issuance of ordinary shares - advisor fees | ||||||||
| Prepayments of lease liabilities | ( | ) | ( | ) | ||||
| Decrease (increase) in right of use assets | ( | ) | ||||||
| Decrease (Increase) in other current assets | ( | ) | ||||||
| (Decrease) increase in trade accounts payable | ( | ) | ||||||
| (Decrease) increase in other accounts payable | ||||||||
| (Increase) decrease in inventory | ( | ) | ( | ) | ||||
| Unrealized foreign exchange (gain) loss | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
| Purchase of property, plant and equipment | ( | ) | ( | ) | ||||
| Change in deposits, net | ( | ) | ||||||
| Change in restricted deposits | ||||||||
| Net cash provided by (used in) investing activities | ( | ) | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
| Issuance of ordinary shares and pre-funded warrants, net | ||||||||
| Issuance of ordinary shares pursuant to an at-the-market facility, net | ||||||||
| Exercise of options | ||||||||
| Net cash provided by financing activities | ||||||||
| Effect of exchange rate changes on cash and cash equivalents | ||||||||
| Net decrease in cash and cash equivalents and restricted cash | ( | ) | ( | ) | ||||
| Cash, cash equivalents and restricted cash at the beginning of the period | ||||||||
| Cash, cash equivalents and restricted cash at the end of the period | ||||||||
| * |
The accompanying notes are an integral part of the financial statements.
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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 | ||||||||
| Restricted Cash | ||||||||
| Total cash, cash equivalents and restricted cash shown in the statement of cash flows | ||||||||
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) | ||||||||
APPENDIX C - AMOUNT PAID DURING THE PERIOD:
| Six months ended June 30, 2025 |
Six months ended June 30, 2024 |
|||||||
| Interest paid | |
|
||||||
The accompanying notes are an integral part of the financial statements.
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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 $ |
| 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. |
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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
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 $
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 | ||||||||
| Work in progress | ||||||||
| Finished goods (*) | ||||||||
| Total | ||||||||
| (*) | 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) | ||||||||
| Non-tradable warrants (2) | ||||||||
| Total | ||||||||
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
The financial liability fair value as of December 31, 2024 and as of June
30, 2025 is $
| 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
The fair value of the 2023 Private Warrants as of
December 31, 2024 and June 30, 2025 was $
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 | ||||||||
| Exercise price | ||||||||
| Risk-free interest rate | % | % | ||||||
| Expected volatility | % | % | ||||||
| Expected dividend yield | % | % | ||||||
| Expected term of warrants | ||||||||
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 | ||||
| Payroll and related | ||||
| Warranty | ||||
| Royalties to IIA | ||||
| Total | ||||
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. |
| For the six-month ended | ||||||||
| June 30, 2025 | June 30, 2024 | |||||||
| Salary and related expenses – officers and directors(1) | ||||||||
| Share based payment – officers and directors(2) | ||||||||
| (1) |
| (2) |
| 2. |
| Name | Nature of transaction | As of June 30, 2025 |
As of December 31, 2024 |
||||||||
| Officers | Salaries and related(1) | ( |
) | ( |
) | ||||||
| Directors | Compensation for directors | ( |
) | ( |
) | ||||||
| (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 |
| 2. | On May 20, 2024, the Company issued warrants, to purchase up to |
| 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 |
| 4. | On June 30, 2024, the Company issued |
| 5. | On December 27, 2024, the Company completed its December Private Placement, whereby the Company sold (i) |
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 $
| 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 $ |
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 |
B. Warrants reserves - Composition and movements:
| 1. |
| Number of Warrants | Weighted-average exercise price | Weighted average remaining contractual term (in years) | ||||||||||
| Balance as of December 31, 2024 | ||||||||||||
| Issued | ||||||||||||
| Exercised | ||||||||||||
| Expired | ||||||||||||
| Balance as of June 30, 2025 | ||||||||||||
| 2. |
| Exercise Price | Warrants outstanding as of June 30, 2025 | Expiration date | ||||
| Balance as of June 30, 2025 | ||||||
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 | ||||||||
| Total number of Ordinary Shares | ||||||||
| Weighted average number of Ordinary Shares | ||||||||
| Basic and diluted loss per share | ( |
) | ( |
) | ||||
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
On January 22, 2024, the Company’s board of
directors approved a grant of
the grant date,
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
On February 5, 2024, the Company’s board of
directors approved a grant of
On February 22, 2025, the Company’s board of
directors approved a grant of
On February 22, 2025, the Company’s board of
directors approved a grant of
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 |
| (ii) | The expected volatility is |
| (iii) | The dividend rate |
| (iv) | Expected term – |
During the six months ended June 30, 2025, the Company
recorded share-based payment expenses in the amount of $
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 | ||||||||
| Granted | ||||||||
| Exercised | ||||||||
| Forfeited | ||||||||
| Outstanding as of June 30, 2025 | ||||||||
| Exercisable options | ||||||||
| Share-based payment expenses | ||||||||
The number of the outstanding vested RSUs to services providers and advisors
as of June 30, 2025, were
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 | ||||||||
| Granted | - | |||||||
| Exercised | ||||||||
| Forfeited | ||||||||
| Outstanding as of June 30, 2025 | ||||||||
| Exercisable options as of June 30, 2025 | ||||||||
| Share-based payment expenses | ( | ) | ||||||
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 | ||||
| Granted | ||||
| Forfeited | ||||
| Vested(1) | ||||
| Outstanding as of June 30, 2025 | ||||
| Vested as of June 30, 2025 | ||||
| Share-based payment expenses(1) | ||||
| (1) | |
| (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
In October 2023,
the IIA approved a support of another development project of the Company at an aggregate budget
of NIS
According to
the agreements with the IIA, the Company will pay royalties of
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 $
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
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 |
| 2. | On July 1, 2025, the shelf capacity was increased, resulting in the Company increasing the maximum ATM
facility capacity to $ |
| 3. | On September 16, 2025, the shelf capacity was increased, resulting
in the Company increasing the maximum ATM facility capacity to $ |
| 4. | On July 2, 2025, the Company received a binding purchase order in the amount of $ |
| 5. | On August 6, 2025, the Company’s board of directors approved
a grant of |
| 6. | On August 6, 2025, the Company’s board of directors approved
the issuance of |
20
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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