As of March 31, 2023, the
Company had $11.5 million in cash,
cash equivalents, and short-term bank deposits
RA'ANANA, Israel, May 18, 2023
/PRNewswire/ -- Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN)
(Nasdaq: IINNW) (the "Company" or "Inspira
Technologies"), a company aiming to revolutionize acute respiratory
care, announced today its financial results for the first quarter
ended March 31, 2023.
Dagi Ben-Noon, Chief Executive Officer of Inspira
Technologies, stated:
"We believe that this is a very important period for the
Company, as we continue to progress towards the regulatory
submission of the New ALICETM Device with the U.S. Food
and Drug Administration (FDA) in the coming months. This is in
addition to the ongoing clinical studies of the HYLATM
non-invasive blood sensor currently underway at Sheba Medical
Center in Israel. The progress of
these devices represents important building blocks of our flagship
INSPIRATM ART system, which is advancing in the
development process."
Highlights:
- May 11, 2023 – We announced that
we are developing the VORTX™ Blood Oxygenator, a disposable
oxygenator unit (kit) that uses a unique technology for saturating
blood with oxygen and removing carbon dioxide. The VORTX is being
designed to be sold separately to an addressable market currently
estimated at $1.16 billion as well as
being made compatible with our INSPIRA ART system and ALICE
device.
- March 22, 2023 - We announced a
First in Human of HYLA™ Blood Sensor in a clinical study. We also
announced the first use of the HYLATM in a patient
undergoing open-heart surgery at Sheba Medical Center in
Israel.
- February 13, 2023 - We announced
that we received approval from Sheba Medical Center to conduct a
clinical study of the HYLA™ Blood Sensor.
- January 23, 2023 - We announced
that we were granted a patent by the U.S. Patent Office for the
INSPIRA™ ART System's Convertible Dual Lumen Cannula Device and
Method of Use. All 20 claims were found to be novel, with inventive
step and industrial applicability.
Financial Results for the Three Months Ended March 31,
2023
Research and development expenses for the three months
ended March 31, 2023, were $2.0
million, compared to $1.5
million for the corresponding period in 2022. The
increase is a result of the Company's recruitment of employees and
the expanded research and development of its new technologies and
operations.
Marketing expenses for the three months ended March 31, 2023, were $168
thousand compared to $472
thousand for the corresponding period in 2022. The decrease
is attributable to decreases in share-based compensation expenses
and a reduction in marketing activities. The marketing department
increase its efforts in the first quarter of 2022 with respect to
brand awareness and exploring go-to-market capabilities.
General and administrative expenses for the three months
ended March 31, 2023, were $1.0
million, compared to $1.5
million for the corresponding period in 2022. The
decrease resulted primarily from a decrease in share-based
compensation expenses.
Finance income for the three months ended March 31, 2023,
was $368 thousand, compared to
$2.2 million for the corresponding
period in 2022. The change in finance income resulted
primarily from the calculation of the fair value of the Company's
financial equity liabilities to pre-initial public offering (IPO)
and IPO investors, in addition to the fluctuation in the U.S.
dollar – New Israeli Shekel exchange rate during the first quarter
of 2023.
Finance expenses for the three months ended March 31, 2023,
were $112 thousand, compared to
$25 thousand for the corresponding
period in 2022.
Net loss for the three months ended March 31,
2023, was $3.0 million, compared
to a net loss of $1.3 million for the
three months ended March 31, 2022.
Balance Sheet Highlights
Cash, cash equivalents and short-term bank deposits were
$11.5 million as of March 31,
2023, compared to $13.9 million as of
December 31, 2022.
Financial liabilities at fair value totaled $431 thousand as of March
31, 2023, compared to $368
thousand as of December 31,
2022. The financial liabilities represent the fair value of
the Company's equity liabilities to pre-IPO and IPO investors.
As of March 31, 2023, the
Company's shareholders' equity totaled $10
million, compared to shareholders' equity totaling
$12.8 million as of December 31, 2022.
Inspira Technologies OXY B.H.N. Ltd.
Inspira Technologies is an innovative medical technology company
in the respiratory treatment arena. The Company has developed a
breakthrough Augmented Respiration Technology (INSPIRA ART),
designed to rebalance patient oxygen saturation levels. This
technology potentially allows patients to remain awake during
treatment while preventing the need for highly invasive, risky, and
costly mechanical ventilation systems that require intubation and
medically induced coma. The Company's products have not yet been
tested or used in humans and has not been approved by any
regulatory entity.
For more information, please visit our corporate
website:
https://inspira-technologies.com/
Forward-Looking Statement Disclaimer
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 its regulatory
strategy, the continuation of its progress towards the regulatory
submission of the ALICE Device with the FDA, the progress of its
clinical studies, and its believe that the progress of its devices
represents important building blocks of its INSPIRA ART system.
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, 2022
filed with the SEC, which is available on the SEC's website,
www.sec.gov.
US Public Relations
Dave
Gentry
RedChip Companies Inc.
1-800-RED-CHIP (733-2447)
Or 407-491-4498
IINN@redchip.com
Copyright © 2018-2023 Inspira Technologies OXY B.H.N. LTD., All
rights reserved.
UNAUDITED CONDENSED
INTERIM STATEMENTS OF FINANCIAL POSITION
|
|
|
(US dollars in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
|
|
2023
|
|
|
2022
|
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
|
Current
Assets:
|
|
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
|
6,362
|
|
|
|
6,783
|
|
|
|
Cash
deposits
|
|
|
5,136
|
|
|
|
7,120
|
|
|
|
Other accounts
receivable
|
|
|
371
|
|
|
|
591
|
|
|
|
Total current
assets
|
|
|
11,869
|
|
|
|
14,494
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Current
Assets:
|
|
|
|
|
|
|
|
|
|
|
Right of use assets,
net
|
|
|
1,004
|
|
|
|
1,107
|
|
|
|
Property, plant and
equipment, net
|
|
|
535
|
|
|
|
411
|
|
|
|
Total non-current
assets
|
|
|
1,539
|
|
|
|
1,518
|
|
|
|
Total Assets
|
|
|
13,408
|
|
|
|
16,012
|
|
|
|
|
|
|
March 31,
|
December
31,
|
|
|
|
|
2023
|
|
|
2022
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
Trade accounts
payables
|
|
|
|
191
|
|
|
|
150
|
|
|
Other accounts
payable
|
|
|
|
1,350
|
|
|
|
1,217
|
|
|
Lease
liabilities
|
|
|
|
307
|
|
|
|
329
|
|
|
Financial Liabilities
at Fair Value
|
|
|
|
431
|
|
|
|
368
|
|
|
Total current
liabilities
|
|
|
|
2,279
|
|
|
|
2,064
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Current
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
Lease
liabilities
|
|
|
|
637
|
|
|
|
728
|
|
|
Loan from the Israeli
Innovation Authority
|
|
|
|
412
|
|
|
|
398
|
|
|
Total non- current
liabilities
|
|
|
|
1,049
|
|
|
|
1,126
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
Equity:
|
|
|
|
|
|
|
|
|
|
|
Share capital and
premium
|
|
|
|
54,397
|
|
|
|
53,814
|
|
|
Foreign exchange
reserve
|
|
|
|
(2,222)
|
|
|
|
(1,928)
|
|
|
Accumulated
deficit
|
|
|
|
(42,095)
|
|
|
|
(39,064)
|
|
|
Total equity
|
|
|
|
10,080
|
|
|
|
12,822
|
|
|
Total Liabilities and
Shareholders' Equity
|
|
|
|
13,408
|
|
|
|
16,012
|
|
|
UNAUDITED CONDENSED
INTERIM STATEMENTS OF COMPREHENSIVE INCOME
|
(US dollars in
thousands)
|
|
|
|
|
|
|
For the Three
Months
Ended March 31,
|
|
|
For the Year
Ended
December 31,
|
|
|
|
|
|
2023
|
|
|
|
2022
|
|
|
2022
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development expenses
|
|
|
|
2,054
|
|
|
|
1,560
|
|
|
8,054
|
|
|
Marketing
expenses
|
|
|
|
|
168
|
|
|
|
472
|
|
|
1,325
|
|
|
General and
administrative expenses
|
|
|
|
|
1,065
|
|
|
|
1,544
|
|
|
5,391
|
|
|
Operating
loss
|
|
|
|
|
3,287
|
|
|
|
3,576
|
|
|
14,770
|
|
|
Finance
)income(
|
|
|
|
|
(368)
|
|
|
|
(2,196)
|
|
|
(4,678)
|
|
|
Finance
expenses
|
|
|
|
|
112
|
|
|
|
|
|
|
181
|
|
|
Loss (profit) before
tax
|
|
|
|
|
3,031
|
|
|
|
1,380
|
|
|
10,273
|
|
|
Taxes on
income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss (profit) for the
period
|
|
|
|
3,031
|
|
|
|
1,380
|
|
|
10,273
|
|
|
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
|
|
|
(294)
|
|
|
|
(425)
|
|
|
(2,138)
|
|
|
Total comprehensive
loss for the period
|
|
|
3,325
|
|
|
|
1,805
|
|
|
12,411
|
|
|
CONDENSED INTERIM
STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
(US dollars in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
For the Three-Month
Period Ended March 31, 2023 (Unaudited):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share capital and
premium
|
|
|
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
|
|
|
-
|
|
|
|
-
|
|
|
|
|
(3,031)
|
|
|
|
(3,031)
|
|
Other comprehensive
loss
|
|
|
-
|
|
|
|
(294)
|
|
|
|
|
-
|
|
|
|
(294)
|
|
Total comprehensive
loss
|
|
|
-
|
|
|
|
((294
|
|
|
|
|
(3,031)
|
|
|
|
(3,325)
|
|
Share-based
compensation
|
|
|
583
|
|
|
|
-
|
|
|
|
|
-
|
|
|
|
583
|
|
Balance on March 31,
2023
|
|
|
54,397
|
|
|
|
(2,222)
|
|
|
|
|
(42,095)
|
|
|
|
10,080
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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SOURCE Inspira Technologies