UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the Month of: May 2022
Commission File Number: 001-40303
Inspira Technologies Oxy B.H.N. Ltd.
(Translation of registrant’s name into English)
2 Ha-Tidhar St.
Ra’anana 4366504, Israel
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
☒ Form 20-F ☐ Form 40-F
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
CONTENTS
Attached hereto and incorporated herein is Inspira Technologies Oxy B.H.N. Ltd.’s (the “Registrant”) press release issued on May 19, 2022, titled “InspiraTM Technologies Announces First Quarter 2022 Financial Results.”
The first paragraph and the sections titled “Highlights,” “Financial Results for the Three Months Ended March 31, 2022,” “Balance Sheet highlights,” “Forward-Looking Statements,” and the IFRS financial statements in the press release are incorporated by reference into the Registrant’s Registration Statement on Form S-8 (Registration No. 333-259057), filed with the Securities and Exchange Commission, to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibit No. | ||
99.1 | Press Release issued by Inspira Technologies Oxy B.H.N. Ltd. on May 19, 2022, titled “InspiraTM Technologies Announces First Quarter 2022 Financial Results.” |
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Inspira Technologies Oxy B.H.N. Ltd. | |||
Date: May 19, 2022 | By: | /s/ Dagi Ben-Noon | |
Name: | Dagi Ben-Noon | ||
Title: | Chief Executive Officer |
2
Exhibit 99.1
Inspira™ Technologies Announces First Quarter 2022 Financial Results
As of March 31, 2022, the Company had $21.7 million in cash
May 19, 2022
Ra’anana, Israel– Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the “Company” or “Inspira Technologies”), a groundbreaking respiratory support technology company, announced today its financial results for the first quarter ended March 31, 2022.
Dagi Ben-Noon, Chief Executive Officer of Inspira Technologies, stated: “The Company continues to be focused on meeting schedules in 2022 for its major milestones, which include revealing a new technology designed for utilization in the ART™ system. Inspira will also continue to drive towards strategic agreements and reach advanced stages of verification and validation (V&V) for the U.S. Food and Drug Administration (the “FDA”) Class II submission for the ECLS System in the first half of 2023. The Company is working with suppliers and manufacturers to meet lead times and managed risks experienced in the global supply chain.”
Highlights: Financial
Results for the Three Months Ended March 31, 2022 Research
and development expenses for the three months ended March 31, 2022, were $1.5 million, compared to $0.6 million for the corresponding
period in 2021. The increase is a result of the Company’s recruitment of specialized manpower and expanded development of
its activities and operations. Marketing
expenses for the three months ended March 31, 2022, were $472,000, compared to $130,000 for the corresponding period in 2021. The
increase is due to the Company’s increase in marketing expenses due to an increase in payroll and share-based compensation expenses.
Marketing activities commenced in the first quarter of 2021 and became more intensive with the Company’s need to create brand awareness
and explore go-to-market capabilities. General
and administrative (G&A) expenses for the three months ended March 31, 2022 were $1.5 million, compared to $0.8 million
for the corresponding period in 2021. The increase resulted primarily from an increase in payroll and related expenses, as well
as an increase in costs associated with the Company’s status as a publicly-traded company, following its initial public offering
(IPO) on Nasdaq in July 2021, the increase in existing and new expenses included professional fees, director fees, and directors’
and officers’ insurance costs. Finance
income for the three months ended March 31, 2022, was $2.1 million compared to expenses in the amount of $5.6 million for the corresponding
period in 2021. The increase in financial expenses or income was due to the calculation of the fair value of the Company’s
financial equity liabilities to pre-IPO and IPO investors. Net
loss for the three months ended March 31, 2022, was $1.3 million, compared to a net loss of $7.2 million for the three months
ended March 31, 2021. Balance
Sheet highlights Cash,
cash equivalents, and short-term bank deposits were $21.7 million as of March 31, 2022, compared to $23.7 million as of December
31, 2022. Financial
liabilities at fair value totaled $1.4 million as of March 31, 2022, compared to $3.2 million as of December 31, 2021. The financial
liabilities represent the fair value of the Company’s equity liabilities to pre-IPO and IPO investors. As
of March 31, 2022, shareholders’ equity totaled $19.8 million, compared to shareholders’ equity totaling $20.3 million as
of December 31, 2021. 2 Inspira
Technologies OXY B.H.N. Ltd. Inspira
Technologies is an innovative medical technology company in the respiratory treatment arena. The Company has developed a breakthrough
Augmented Respiration Technology (ART), designed to rebalance patient oxygen saturation levels. The Company’s ART technology potentially
allows patients to remain awake during treatment while minimizing the need for highly invasive, risky, and costly mechanical ventilation
systems that require intubation and medically induced coma. The Company’s product has not yet been tested or used in humans and
has not been approved by any regulatory entity. For
more information, please visit our corporate website: Forward-Looking
Statement Disclaimer For
more details: Miri
Segal, Investor Relations, MS-IR LLC +917-607-8654
msegal@ms-ir.com MRK-ARS-025 Copyright
© 2018-2022 Inspira Technologies OXY B.H.N. LTD., All rights reserved. 3 UNAUDITED
CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION (US
dollars in thousands) 4 UNAUDITED
CONDENSED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (US
dollars in thousands) 5 CONDENSED
INTERIM STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (US
dollars in thousands) For
the Three-Month Period Ended March 31, 2022 (Unaudited): 6
Ø January
9, 2022 - Professor Daniel Brodie, the President-Elect of the International Extracorporeal
Organization (ELSO) and Director of Critical Care from New York Columbia – Presbyterian
Hospital, joined Inspira Technologies’ Advisory Board.
Ø January
28, 2022 - Inspira Technologies listed an FDA Class I 510(k) exempt component of the
ART system.
Ø January
31, 2022 - Inspira Technologies signed a Strategic Agreement in the U.S. to target $212
Million for Inspira Technologies over a 7-Year period, subject to regulatory approvals. The
agreement is with U.S. based Glo-Med Networks for the potential deployment of 2,121 ART systems
in 6 states in the United States.
Ø February
3, 2022 - Inspira Technologies appointed an expert in the field of artificial lung as
its New Chief Technology Officer (CTO) –Daniella Yeheskely-Hayon, Ph.D.
Ø February
27, 2022 - Inspira Technologies announced that it was awarded with the 2021 Frost &
Sullivan Best Practices Technology Innovation Leadership Award.
Ø April
6, 2022 - Inspira Technologies announced a Deployment Agreement in the Israeli Market
to potentially target $15 Million. The agreement is for a 7-year period, and is subject to
regulatory approval.
https://inspira-technologies.com/
Ø 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 meeting milestones in 2022 and the timing for such milestones,
the submission of the ART system in the second quarter of 2023, a strategic agreement in
the U.S. for the potential deployment of 2,121 ART systems in 6 states of the United States
and the targeted amount that may be derived under the agreement over a 7-year period, subject
to regulatory approvals, and a deployment agreement for a 7-year period in the Israeli market
and the targeted amount to be derived under the agreement, subject to regulatory approval.
These forward-looking statements and their implications are based solely on the current expectations
of the Company’s management and are subject to a number of factors and uncertainties
that could cause actual results to differ materially from those described in the forward-looking
statements. Except as otherwise required by law, the Company undertakes no obligation to
publicly release any revisions to these forward-looking statements to reflect events or circumstances
after the date hereof or to reflect the occurrence of unanticipated events. More detailed
information about the risks and uncertainties affecting the Company is contained under the
heading “Risk Factors” in the Company’s annual report on Form 20-F for
the fiscal year ended December 31, 2021 filed with the SEC, which is available on the SEC’s
website, www.sec.gov.
March 31,
December 31,
2022
2021
ASSETS
Current Assets:
Cash and cash equivalents
21,756
23,749
Other accounts receivable
433
639
Restricted cash
78
120
Total current assets
22,267
24,508
Non-Current Assets:
Right of use assets, net
1,169
1,160
Property, plant and equipment, net
227
202
Total non-current assets
1,396
1,362
Total Assets
23,663
25,870
March 31,
December 31,
2022
2021
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current Liabilities:
Trade accounts payables
137
93
Other accounts payable
794
725
Lease liabilities
323
281
Financial Liabilities at Fair Value
1,426
3,215
Total current liabilities
2,680
4,314
Non-Current Liabilities:
Lease liabilities
871
900
Loan from the Israeli Innovation Authority
309
302
Total non- current liabilities
1,180
1,202
Shareholders’ Equity:
Share capital and premium
50,189
48,935
Foreign exchange reserve
(215 )
210
Accumulated deficit
(30,171 )
(28,791 )
Total equity
19,803
20,354
Total Liabilities and Shareholders’ Equity
23,663
25,870
For the Three-Month Period
Ended
March 30,
For the Year
Ended
December 31,
2022
2021
2021
Research and development expenses
1,560
667
3,909
Marketing expenses
472
130
1,951
General and administrative expenses
1,544
821
7,572
Operating loss
3,576
1,618
13,432
Finance expenses (income)
(2,196 )
5,673
3,523
Loss (profit) before tax
1,380
7,291
16,955
Taxes on income
Loss (profit) for the period
1,380
7,291
16,955
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
(425 )
(215 )
845
Total comprehensive loss for the period
1,805
7,506
(16,110 )
Share capital and premium
Adjustments arising from translating financial operation
Accumulated deficit
Total
Balance at January 1, 2022
Changes during the period:
48,935
210
(28,791 )
20,354
Loss for the period
-
-
(1,380 )
(1,380 )
Other comprehensive loss
-
(425 )
-
(425 )
Total comprehensive loss
-
(425 )
(1,380 )
(1,805 )
Share-based compensation
1,254
-
-
1,254
Balance on March 31, 2022
50,189
(215 )
(30,171 )
19,803