EX-99.2 3 ea166440ex99-2_inspiratech.htm INSPIRA TECHNOLOGIES OXY B.H.N. LTD.'S MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION FOR THE SIX MONTHS ENDED JUNE 30, 2022

Exhibit 99.2

 

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 ability to advance the development of our products and future potential product candidates;
     
  our ability to commercialize our products and future potential product candidates and future sales of our product or any other future potential product candidates;
     
  our assessment of the potential of our products and future potential product candidates to treat certain indications;
     
  our planned level of 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 the 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 COVID-19 and resulting government actions on us;
     
  the impact of competition and new technologies;
     
  general market, political and economic conditions in the countries in which we operate;
     
  the impact of competition and new technologies;
     
  our ability to internally develop new inventions and intellectual property;
     
  our expectations regarding the use of proceeds from this offering
     
  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 our company, reference is made to our annual report on Form 20-F for the fiscal year ended December 31, 2021 which we filed with the Securities and Exchange Commission, or the SEC, on March 31, 2022, or the Annual Report, and the other risk factors discussed from time to time by our company 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 report under International Financial Reporting Standards as issued by the International Accounting Standards Board. None of the financial statements were prepared 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, 2022, included elsewhere in this Report 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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Overview

 

Since our inception in 2018, we have incurred operating losses. Our operating loss for the six-months ended June 30, 2022 and 2021 were $8 million and $2.6 million, respectively, and our net loss for the same period was $3.4 million and $8.3 million, respectively. As of June 30, 2022, we had an accumulated deficit of $32.2 million. We expect to continue to incur significant 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 product pursuant different regulatory pathway in the United States;
     
  continue to invest in the preclinical research and development of any future product candidates;
     
  establish a commercial infrastructure to support the marketing, sale and distribution of our product if it receives 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.

 

We do not have any products approved for sale and have not generated any revenue from product sales.

 

Current Outlook

 

On July 16, 2021, we closed our initial public offering, or IPO, whereby we sold 2,909,091 ordinary shares and 3,345,455 tradable warrants (inclusive of 436,364 tradable warrants pursuant to the exercise of an overallotment option granted to the underwriters). The aggregate net proceeds received by us from the IPO were $16 million, before underwriting discounts and other offering costs. Prior to our IPO, we financed our operations primarily through convertible debt, as well as grants from the Israel Innovation Authority, or the IIA.

 

We have incurred losses and generated negative cash flows from operations since inception in 2018. Since inception, we have not generated any revenue and we do not expect to generate significant revenues in the near future.

 

As of June 30, 2022, our cash and cash equivalents were $14,154,000 and cash under deposits was $5,020,000.

 

We expect that our existing cash and cash equivalents, deposits and restricted cash as of the June 30, 2022 will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months.

 

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

 

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Quantitative and Qualitative Disclosures about Market Risk

 

Foreign Currency Exchange Risk

 

We operate primarily in Israel, and approximately 80% 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.

 

We currently partially hedge our foreign currency exchange rate risk to decrease the risk of financial exposure from fluctuations in the exchange rates of our principal operating currencies. These measures, however, may not adequately protect us from the material adverse effects of such fluctuations.

 

Interest Rate Risk

 

We do not anticipate undertaking any significant long-term borrowings. 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 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, 2022. 

 

Operating Expenses

 

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

 

Revenue

 

To date, we have not generated revenue from the sale of any product, and we do not expect to generate significant revenue within the next 12 months.

 

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 developments of our product service fees and other related research and development expenses.

 

In October 2019, we received the approval of the IIA for its participation in certain development expenses carried out by the Company, within the framework of determined budgets and time periods. Through June 30, 2022, we received a total of $843,000 from the IIA and no additional grants are expected to be received.

 

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

 

Unaudited  Six Months Ended
June 30,
 
U.S. dollars in thousands  2022   2021 
         
Salary and related expenses   1,441    584 
Materials and related expenses   392    80 
Subcontractors   682    147 
IIA participation   -    (51)
Share-based compensation   1,594    241 
Depreciation   100    59 
Office maintenance   33    44 
Other   52    - 
Total   4,294    1,104 

  

We expect that our research and development expenses will increase as we continue to develop our products and will start regulations filings and clinical processes.

 

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 discloses the breakdown of general and administrative expenses:

 

Unaudited  Six Months Ended
June 30,
 
U.S. dollars in thousands  2022   2021 
         
Professional fees   754    715 
Share-based compensation   657    222 
Director’s fees and share based compensation   644    - 
Salary and related expenses   375    186 
Insurance expenses   356    - 
Depreciation   66    34 
Rent and office maintenance   56    25 
Travel abroad   20    14 
Others   8    14 
Total   2,936    1,210 

  

Comparison of the Six Months Ended June, 2022 and 2021

 

Results of Operations

 

   Six Months Ended
June 30,
 
U.S. dollars in thousands  2022   2021 
     
Research and development expenses   4,294    1,104 
Marketing expenses   777    244 
General and administrative expenses   2,936    1,210 
Operating loss   8,007    2,558 
Financial expenses   (4,534)   5,732 
Net loss   3,473    8,290 
Loss attributable to holders of Ordinary Shares   3,473    8,290 

 

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Research and Development Expenses

 

Research and development expenses for the six months ended June 30, 2022, were $4,294,000 compared to $1,104,000 for the corresponding period in 2021. The increase is a result of the Company’s recruitment of specialized manpower and the expanded development of its new technologies and operations.

 

Marketing expenses

 

Marketing expenses for the six months ended June 30, 2022, were $777,000, compared to $244,000 for the corresponding period in 2021. The increase is attributed to increases in marketing, payroll, and share-based compensation expenses. Marketing activities commenced in the first quarter of 2021 and became more intensive during 2022 with the Company’s need to create brand awareness and explore go-to-market capabilities.

 

General and administrative expenses

 

General and administrative expenses for the six months ended June 30, 2022 were $2.9 million, compared to $1.2 million for the corresponding period in 2021. The increase stemmed primarily from an increase in payroll and related expenses, as well as costs associated with the Company’s status as a publicly traded company following its IPO in July 2021, the increase in existing and new expenses included professional fees, director fees, and directors’ and officers’ insurance costs.

 

Operating loss

 

As a result of the foregoing, our operating loss for the six months ended June 30, 2022 was $8,007,000 compared to an operating loss of $2,558,000 for the six months ended June 30, 2021, an increase of $5,449,000, or 213%.

 

Financial expenses

 

Financial expenses consist of revaluation of debt instruments presented at fair value and bank fees.

 

We recognized financial income for the six months ended June 30, 2022 of $4,534,000 compared to financial expenses of $5,732,000 for the six months ended June 30, 2021. The increase in finance income derived mainly from the calculation of the fair value of the Company’s financial equity liabilities to pre-IPO and IPO investors are calculated based on the share price which was decreased radically from the IPO price.

 

Total comprehensive loss

 

As a result of the foregoing, our total comprehensive loss for the six months ended June 30, 2022 was $5,708,000, compared to $8,323,000 for the six months ended June 30, 2021, a decrease of $2,615,000, or 31%. The total comprehensive loss was primarily due to exchange losses arising from currency translations for the six months ended June 30, 2022, in the amount of $2,235,000, compared to income in the amount of $33,000 for the six months ended June 30, 2021.

 

Impact of COVID-19

 

The global spread of COVID-19 led many countries, including Israel, to impose stringent limitations on movement, gatherings, transit of passengers and goods and to close the borders between countries. The responses of governments have notably impacted many economies as well as capital markets worldwide.

 

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Our company was able to maintain almost ordinary levels of operations during the period including the performance of its planned studies. We were affected by service providers lack of availability and extended times of delivery from suppliers abroad.  We also experienced several weeks of delay in receiving components for the products during the first half of 2020 and we sill experience delay in supply dates and purchase processes due to lack of components and high demands.

 

Future possible impact of COVID-19 will depend on future developments with the pandemic which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of COVID-19 and the actions by governments around the world to contain COVID-19 or treat its impact, among others.

 

Critical Accounting Policies and 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 Policies and 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, 2022, included elsewhere in this Report Form 6-K.

 

B. Liquidity and Capital Resources

 

Overview

 

Since our inception through June 30, 2022, we have funded our operations principally from the proceeds of our IPO, convertible securities and loans and from government grants.

 

As of June 30, 2022, we had $19,174,000 in cash, cash equivalents and restricted cash.

 

The table below presents our cash flows for the six months ended June 30, 2022:

 

   Six Months Ended
June 30,
 
U.S. dollars in thousands  2021   2021 
         
Net cash used in operating activities   (1,962)   (2,330)
           
Net cash used in investing activities   (5,007)   (898)
           
Net cash provided(used) by financing activities   (156)   7,114 
           
Net increase in cash and cash equivalents   (7,124)   3,886 

 

Operating Activities

 

Net cash used in operating activities of $1,962,000 during the six months ended June 30, 2022 and net cash used in operating activities of $2,330,000 during the six months ended June 30, 2021 were primarily used for payment of salaries and related personnel expenses, materials expenses, subcontractors, travel and office maintenance. The change is due to expenses used the company in order to prepare the company to the IPO.

  

Investing Activities

 

Net cash used in investing activities of $5,007,000 during the six months ended June 30, 2022, consisted mainly of short-term deposits in the amount of $4,994,000 and $55,000 used for purchasing property and equipment. Net cash used in investing activities of $898,000 during the six months ended June 30, 2021, consisted mainly of a short time restricted deposit in amount of $857,000 and $41,000 used for purchasing property and equipment. 

 

Financing Activities

  

Net cash used in financing activities of $156,000 during the six months ended June 30, 2022, consisted of principal paid on lease liabilities.

 

Net cash provided by financing activities of $7,114,000 during the six months ended June 30, 2021, consisted primarily of $7,165,000 of net proceeds from convertible loans and simple agreements for future equity, and from a $55,000 grant from the IIA.

 

 

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