IINN Inspira Technologies Oxy B H N Ltd

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

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

UNDER THE SECURITIES EXCHANGE ACT OF 1934

 

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

 

Commission File Number: 001-40303

 

Inspira Technologies Oxy B.H.N. Ltd.

(Translation of registrant’s name into English)

 

2 Ha-Tidhar St.

Ra’anana 4366504, Israel

(Address of principal executive office)

 

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

 

☒ Form 20-F      ☐ Form 40-F

 

 

 

CONTENTS

 

On November 16, 2023, Inspira Technologies Oxy B.H.N. Ltd., or the Registrant, issued a press release titled “Inspira™ Technologies Reports Third Quarter 2023 Financial Results,” a copy of which is furnished as Exhibit 99.1 with this report of foreign private issuer on Form 6-K.

 

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and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished. 

 

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

 

 

SIGNATURES

 

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

 

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

 

 

2

 

Exhibit 99.1

 

 

 

Inspira™ Technologies Reports Third Quarter 2023 Financial Results

 

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

 

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

 

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

 

Financial Results for the nine months ended September 30, 2023

 

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

 

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

 

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

 

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

 

 

 

 

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

 

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

 

Financial highlights for the three months ended September 30, 2023

 

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

 

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

 

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

 

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

 

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

 

Balance Sheet Highlights

 

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

 

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

 

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

 

 

 

 

 

Inspira Technologies OXY B.H.N. Ltd.

 

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

 

For more information, please visit our corporate website: 

https://inspira-technologies.com/

 

Forward-Looking Statement Disclaimer

 

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

 

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

 

 

 

 

 

UNAUDITED CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION

(U.S. dollars in thousands)

 

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

 

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

 

 

 

 

 

UNAUDITED CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE LOSS

(U.S. dollars in thousands)

 

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

 

 

 

 

 

UNAUDITED CONDENSED INTERIM STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

(U.S. dollars in thousands)

 

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

 

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

 

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

 

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

 

 

 

 

6

 

---