UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 20202021

OR

[  ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _________to _________

Commission File Number: 001-38892

BEYOND AIR, INCINC..

(Exact name of registrant as specified in its charter)

Delaware47-3812456

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer

Identification No.)

   
825 East Gate Boulevard, Suite 320
Garden City, NY11530
(Address of principal executive offices)(Zip Code)

516-665-8200516-665-8200

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class:Trading SymbolName of each exchange on which registered:
Common Stock, par value $0.0001 per shareXAIRThe Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] ☒ No [  ]

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes [X] ☒ No [  ]

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

Large accelerated filer [  ]Accelerated Filer [  ]
Non-accelerated filer [X]Smaller reporting company [X]
Emerging growth company [X]

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [  ]

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [  ] No [X] ☒

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date. As of August 3, 2020,6, 2021, there were 17,147,21423,947,879 shares of common stock, par value $0.0001 per share, outstanding.

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

INDEX TO FORM 10-Q FILING

FOR THE PERIOD ENDED JUNE 30, 20202021

Table of Contents

Page
PART I FINANCIAL INFORMATION3
ITEM 1. Condensed Consolidated Financial Statements. (Unaudited)3
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.2524
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk3132
ITEM 4. Controls and Procedures32
PART II OTHER INFORMATION33
  
ITEM 1. Legal proceedings33
ITEM 1A. Risk Factors33
ITEM 3. Unregistered Sales of Equity Securities and Use of Proceeds33
ITEM 4. Controls and ProceduresMine Safety3133
PART II OTHER INFORMATIONITEM 5. Other Information3233
ITEM 6. Exhibits.Exhibits3233
SIGNATURES3334

2

PART I FINANCIAL INFORMATION

ITEM 1. Financial Statements.

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

INDEX

Page
Condensed Consolidated Balance Sheets4
Condensed Consolidated Statements of Operations5
Condensed Consolidated Statements of Changes in Shareholders’Stockholders’ Equity6
Condensed Consolidated Statements of Cash Flows7
Notes to Condensed Consolidated Financial Statements8 - 24– 23

3

BEYOND AIR, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

 June 30, 2020  March 31, 2020  June 30, 2021  March 31, 2021 
 (Unaudited)    (Unaudited) 
ASSETS                
Current assets                
Cash and cash equivalents $23,808,900  $19,829,275  $38,581,386  $34,630,682 
Restricted cash  636,317   5,635,836   1,046,606   637,025 
Grant receivable   -   425,000 
Other current assets and prepaid expenses  1,207,238   1,149,806   1,325,064   1,530,096 
Total current assets  25,652,455   26,614,917   40,953,056   37,222,803 
Licensed right to use technology  403,244   412,763   365,158   374,686 
Right-of-use lease assets  398,102   195,727   1,815,351   1,860,885 
Property and equipment, net  421,214   211,337   897,550   928,842 
Other assets  137,880   137,880 
TOTAL ASSETS $26,875,015  $27,434,744  $44,168,995  $40,525,096 
                
LIABILITIES AND SHAREHOLDERS’ EQUITY        
LIABILITIES AND STOCKHOLDERS’ EQUITY        
Current liabilities                
Accounts payable $1,920,337  $2,256,229  $2,261,777  $1,324,988 
Accrued expenses  1,084,604   1,097,534   1,695,235   1,804,938 
Deferred revenue  644,029   873,190 
Stock to be issued to a vendor  -   240,000 
Operating lease liability  79,668   69,342   187,288   113,141 
Loan payable  209,579   335,358   349,165   556,514 
Total current liabilities  3,938,217   4,871,653   4,493,465   3,799,581 
                
Long-term liabilities                
Operating lease liability  323,270   131,581   1,720,389   1,789,461 
Facility agreement loan, net  4,372,257   4,339,065 
Long-term debt, net  4,505,393   4,472,201 
Total liabilities  8,633,744   9,342,299   10,719,247   10,061,243 
Commitments and contingencies               
                
Shareholders’ equity        
Stockholders’ equity        
Preferred Stock, $0.0001 par value per share: 10,000,000 shares authorized, 0 shares issued and outstanding  -   -   -   - 
Common Stock, $0.0001 par value per share: 100,000,000 shares authorized,16,841,555 and 16,056,360 shares issued and outstanding as of June 30, 2020 and March 31, 2020, respectively  1,684   1,606 
Common Stock, $0.0001 par value per share: 100,000,000 shares authorized, 23,267,649 and 21,828,244 shares issued and outstanding as of June 30, 2021 and March 31, 2021, respectively  2,327   2,183 
Treasury stock  (25,000)  (25,000)  (25,000)  (25,000)
Additional paid-in capital  82,593,467   75,702,915   120,677,112   110,948,477 
Accumulated deficit  (64,328,880)  (57,587,076)  (87,204,691)  (80,461,807)
Total shareholders’ equity  18,241,271   18,092,445 
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $26,875,015   27,434,744 
Total stockholders’ equity  33,449,748   30,463,853 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $44,168,995   40,525,096 

The accompanying notes are an integral part of these condensed consolidated financial statements.

4

BEYOND AIR, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

 

For the Three Months Ended

June 30,

  2021  2020 
 2020  2019  

For the Three Months Ended

June 30,

 
      2021  2020 
License revenues $229,161  $627,469 
     
License revenue $-  $229,161 
                
Operating expenses                
Research and development  4,331,814   2,323,513   2,741,041   4,331,814 
General and administrative  2,494,014   2,182,558   3,850,265   2,494,014 
                
Operating loss  (6,596,667)  (3,878,602)  (6,591,306)  (6,596,667)
                
Other income (loss)                
Realized and unrealized loss on marketable equity securities  -   (2,307,319)
Dividend income  14,985   6,410   706   14,985 
Foreign exchange gain  1,275   1,724   9,859   1,275 
Interest expense  (163,240)  (3,034)  (162,143)  (163,240)
Other  1,843   -   -   1,843 
Total other loss  (145,137)  (2,302,219)  (151,578)  (145,137)
                
Net loss $(6,741,804) $(6,180,821) $(6,742,884) $(6,741,804)
                
Net loss per share – basic and diluted $(0.40) $(0.67) $(0.31) $(0.41)
                
Weighted average number of common shares outstanding – basic and diluted  16,529,392   9,201,855   21,945,235   16,529,392 

The accompanying notes are an integral part of these condensed consolidated financial statements.

5

BEYOND AIR, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’STOCKHOLDERS’ EQUITY

(UNAUDITED)

FOR THE THREE MONTHS ENDED JUNE 30, 2021

   Number   Amount   Stock   Capital   Deficit   Equity 
  Common Stock  Treasury  Additional Paid-in  Accumulated  

Total

Stockholders’

 
  Number  Amount  Stock  Capital  Deficit  Equity 
Balance as of April 1, 2021  21,828,244  $2,183  $(25,000) $110,948,477  $(80,461,807) $30,463,853 
At-The-Market issuance of common stock, net  1,239,405   124   -   7,481,444   -   7,481,568 
Issuance of common stock pursuant to a Purchase Agreement, net  200,000   20   -   1,031,280   -   1,031,300 
Stock-based compensation              1,215,911       1,215,911 
Net loss  -   -   -   -   (6,742,884)  (6,742,884)
Balance as of June 30, 2021  23,267,649  $2,327  $(25,000) $120,677,112  $(87,204,691) $33,449,748 

BEYOND AIR, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(UNAUDITED)

FOR THE THREE MONTHS ENDED JUNE 30, 2020

 Common Stock  Treasury  Additional Paid-in  Accumulated  

Total

Shareholders’

  Common Stock  Treasury  Additional Paid-in  Accumulated  

Total

Stockholders’

 
 Number  Amount  Stock  Capital  Deficit  Equity  Number  Amount  Stock  Capital  Deficit  Equity 
Balance as of April 1, 2020  16,056,360  $1,606  $(25,000) $75,702,915  $(57,587,076) $18,092,445   16,056,360  $1,606  $(25,000) $75,702,915  $(57,587,076) $18,092,445 
At the market stock issuance of common stock, net  113,712   11   -   899,529   -   899,540 
At-The-Market issuance of common stock, net  113,712   11   -   899,529   -   899,540 
Issuance of common stock upon exercise of warrants  70,538   7       293,104       293,111   70,538   7       293,104       293,111 
Issuance of common stock upon exercise of stock options  2,340   -   -   545   -   545   2,340   -   -   545   -   545 
Issuance of common stock pursuant to a Purchase Agreement, net  568,605   57   -   3,641,623   -   3,641,680   568,605   57   -   3,641,623   -   3,641,680 
Issuance of common stock to investor relations firm  30,000   3       242,097       242,100   30,000   3       242,097       242,100 
Stock-based compensation              1,813,654       1,813,654               1,813,654       1,813,654 
Net loss  -   -   -   -   (6,741,804)  (6,741,804)  -   -   -   -   (6,741,804)  (6,741,804)
Balance as of June 30, 2020  16,841,555  $1,684  $(25,000) $82,593,467  $(64,328,880) $18,241,271   16,841,555  $1,684  $(25,000) $82,593,467  $(64,328,880) $18,241,271 

BEYOND AIR, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY

(UNAUDITED)

FOR THE THREE MONTHS ENDED JUNE 30, 2019

  Common Stock  Treasury  Additional Paid-in  Accumulated  

Total

Shareholders’

 
  Number  Amount  Stock  Capital  Deficit  Equity 
Balance as of April 1, 2019  8,714,815  $871  $(25,000) $41,693,578  $(37,644,572) $4,024,877 
Issuance of common stock pursuant to a Purchase Agreement, net  250,000   25   -   1,173,785   -   1,173,810 
Issuance of common stock upon exercise of options  32,122   3   -   83,854   -   83,857 
Issuance of common stock pursuant to a private placement, net of offering cost  1,583,743   159   -   7,839,336   -     7,839,495 
Stock-based compensation              919,037       919,037 
Net loss  -   -   -   -   (6,180,821)  (6,180,821)
Balance as of June 30, 2019  10,580,680  $1,058  $(25,000) $51,709,590  $(43,825,393) $7,860,255 

The accompanying notes are an integral part of these condensed consolidated financial statements.

6

BEYOND AIR, INC. AND ITS SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

 2021 2020 
 For the Three Months Ended
June 30,
  For the Three Months Ended June 30, 
 2020  2019  2021 2020 
          
Cash flows from operating activities                
Net loss $(6,741,804) $(6,180,821) $(6,742,884) $(6,741,804)
Adjustments to reconcile net loss to net cash used in operating activities                
Depreciation and amortization  33,650   17,902   58,347   33,650 
Amortization of licensed right to use technology  9,519   53,680   9,528   9,519 
Stock-based compensation  1,815,654   941,537   1,215,911   1,815,654 
Amortization of debt discount  33,192   -   33,192   33,192 
Amortization of operating lease assets  16,513   15,135 
Operating lease expense  50,608   1,483 
Gain on cancellation of operating lease  (1,843)  -   -   (1,843
Realized and unrealized loss on marketable equity securities  -   2,307,319 
Foreign currency adjustment  (9,859)  - 
Deferred revenue  -   

(229,161

)
Changes in:                
Grant receivable  425,000   - 
Other current assets and prepaid expenses  (57,432)  243,258   205,032   (57,432
Accounts payable  (335,893)  388,330   946,648   (335,893
Accrued expenses  (12,830)  (53,089)  

(109,701

)  (12,830)
Lease payments  (15,030)  (15,693)
Deferred revenue  (229,161)  (627,469 
Net cash used in operating activities  (5,485,465)  (2,909,911)  (3,918,178)  (5,485,465)
                
Cash flows from investing activities                
Investment in marketable securities  -   (16,459,011)
Proceeds from redemption of marketable securities  -   9,687,121 
Purchase of property and equipment  (243,527)  (3,112)  (27,055)  (243,527)
Net cash used in investing activities  (243,527)  (6,775,002)  (27,055)  (243,527)
                
Cash flows from financing activities                
Issuance of common stock in connection with a Purchase Agreement with Lincoln Park, At the Market Offerings, private placement, net, exercise of warrants and stock options  4,834,877   9,097,162 
Issuance of common stock in connection with a Purchase Agreement with Lincoln Park, At- The Market Equity Offering, private placement, net, exercise of warrants and stock options  8,512,867   4,834,877 
Payment of loan  (125,779)  (116,366)  (207,349)  (125,779)
Net cash provided by financing activities  4,709,098   8,980,796   8,305,518   4,709,098 
                
Decrease in cash, cash equivalents and restricted cash  (1,019,894)  (704,117)
Increase (decrease) in cash, cash equivalents and restricted cash  4,360,285   (1,019,894)
Cash, cash equivalents and restricted cash at beginning of period  25,465,111   1,357,137   35,267,707   25,465,111 
Cash, cash equivalents and restricted cash at end of period $24,445,217  $653,020  $39,627,992  $24,445,217 
Supplemental disclosure of non-investing activities                
Right-of-use assets $236,700  $258,605  $-  $236,700 
Operating lease liability $236,700  $266,570  $-  $236,700 
Disposition of right-of-use asset $(17,426) $258,605  $-  $(17,426)
Disposition of operating lease liability $19,329  $-  $-  $19,329 
Stock issued to investor relations firm $242,100   -  $-  $242,100 
Supplemental disclosure of cash flow items:                
Interest paid $22,298  $1,676  $136,032  $22,298 
Income taxes paid $-  $- 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

7

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 1 ORGANIZATION AND BUSINESS

Beyond Air, Inc. (“Beyond(together with its subsidiaries, “Beyond Air” or the “Company”) was incorporated on April 24,28, 2015. On June 25, 2019, the Company’sour name was changed to Beyond Air, Inc. from AIT Therapeutics, Inc. The Company hasWe have the following wholly-owned subsidiaries:

Beyond Air Ltd. (“BA Ltd.) was incorporated in Israel on May 1, 2011.2011 in Israel.

Advanced Inhalation Therapies (AIT), a wholly owned subsidiary of Beyond Air, Ltd. was incorporated on August 29, 2014, in Delaware.

Beyond Air Australia Pty Ltd. was, incorporated on December 17, 2019 in Australia.

Beyond Air Ireland Limited, was incorporated on March 5, 2020 in Ireland.

The CompanyBeyond Air is a clinical-stage medical device and biopharmaceutical company focused on developing inhaled Nitric Oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO for the treatment of solid tumors. Since its inception, the Company has devoted substantially all of its efforts to research and development.

The Company is developing a nitric oxide (“NO”) generator and delivery system (the “LungFit® system”) that is capable of generating NO from ambient air. The LungFit™LungFit® platform can generate NO up to 400 parts per million (“ppm”) for delivery to a patient’s lungs. The LungFit™lungs directly or via a ventilator. LungFit® can deliver NO either continuously or for a fixed amount of time at various flow rates and has the ability to either titrate dose on demand or maintain a constant dose. OurBeyond Air believes that LungFit® can be used to treat patients on ventilators that require NO, as well as patients with chronic or acute severe lung infections via delivery through a breathing mask or similar apparatus. Furthermore, the Company believes that there is a high unmet medical need for patients suffering from certain severe lung infections that the LungFit® platform can potentially address. The Company current areas of focus with the LungFit™LungFit® are persistent pulmonary hypertension of the newborn (“PPHN”)(PPHN), severe acute respiratory syndrome coronavirus 2 (SARS CoV-2),viral pneumonia (AVP) including COVID-19, bronchiolitis (“BRO”)(BRO) and nontuberculous mycobacteria (“NTM”)(NTM) lung infection. The Company’s current product candidates will be subject to premarket reviews and approvals by the U.S. Food and Drug Administration (the “FDA”), CE marking conformity assessment by a notified body in the European Union, as well as similar regulatory agencies’ reviews or the FDA,approvals, as well as similar regulatory agencies in other countries or regions. If approved, ourthe Company’s system will be marketed as a medical device initially in the United States.

Liquidity Risks and Uncertainties

The Company has incurredused cash used in operating activities of $5.5 $3.9 million for the three months ended June 30, 2020,2021, and has accumulated losses of $64.3 $87.2 million. The Company has cash,had cash, equivalents and restricted cash of $24.4 $39.6 million as of June 30, 2020.2021. Based on management’s current business plan, the Company estimates it will have enough cash and liquidity sufficient to finance its operating requirements for at least one year from the date of filing these financial statements.

The Company’s future capital needs and the adequacy of its available funds beyond one year will depend on many factors, including, but not necessarily limited to, the actual cost and time necessary for current and anticipated preclinical studies, clinical studiestrials and other actions needed to obtain regulatory approval of ourthe Company’s medical devices in development as well as the cost to launch ourthe Company’s first product for PPHN, assuming approval of our Premarketing Application (“PMA”) which is expected to be filed at the end of September 2020.

8

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 1 ORGANIZATION AND BUSINESS (continued)

Beyond Air’s PMA. The Company willmay be required to raise additional funds through sale of equity or debt securities offerings or through strategic collaboration and/or licensing agreements in order to fund operations and continue our clinical trials until we areit is able to generate enough product or royalty revenues, if any. FinancingSuch financing may not be available on acceptable terms, or at all, and ourthe Company’s failure to raise capital when needed could have a material adverse effect on our growth plans, ourits strategic objectives, results of operations and our financial condition.

The Company’s future liquidity includes access to the following:

8
 

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 1 ORGANIZATION AND BUSINESS (continued)

Liquidity Risks and Uncertainties

The Company’s access to capital and liquidity currently includes the following:

a)Ona)At-The-Market Equity Offering Sales Agreement (the “ATM”) for $50 million which approximately $29.9 million remained as of June 30, 2021, see Note 5.
b)A $25 million unsecured loan with certain lenders to a facility agreement dated April 2, 2020 Beyond Air, Inc. entered into an At-The-Market Equity Offering for $50 million and utilized the Company’s shelf registration statement, see Note 5.
b)On March 17, 2020, the Company entered into a $25 million unsecured loan facility agreement (the “Facility“the Facility Agreement”) with certain lenders.. The Company has drawn down the first of five tranches of $5 $5 million and has the ability to drawndraw down on an additional $5 $5 million tranche at any time prior March 17, 2022 as well as the ability to draw down the remaining $15 $15 million in three subsequent tranches after the FDA approval of the LungFit™LungFit® PH, product. see Note 11.12.
c) OnA $40 million Stock Purchase Agreement with Lincoln Park Capital Fund, LLC (“LPC”) dated as of May 14, 2020 the Company entered into a $40 of which approximately $28.2 million purchase agreement (“New Purchase Agreement”)remains available as of June 30, 2021 with Lincoln Park Capital Fund, LLC (“LPC”), that replaces the existing $20 million purchase agreement. The New Purchase Agreementwhich provides for the issuance of up to $40 million of the Company’s common stockissuances through May 2023 at the Company’s discretion, The Company utilized the shelf registration statement, see Note 5.

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES

Basis of Presentation

The unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“USU.S. GAAP”) for interim financial information and with the instructions to the Form 10-Q. Accordingly, they do not include all of the information and footnotes required to be presented for complete financial statements. The accompanying unaudited condensed consolidated financial statements reflect all adjustments (consisting only of normal recurring items) which are, in the opinion of management, necessary for a fair presentation of the results for the interim periods presented. The accompanying unaudited condensed consolidated Balance Sheetbalance sheet as of March 31, 2020 has been derived from2021 (the “2021 Annual Report”), filed with the audited consolidated financial statements included in our Annual ReportU.S. Securities and Exchange Commission (the “SEC”) on Form 10-K for the year ended March 31, 2020June 10, 2021 and amended on July 23, 2021. The unaudited condensed consolidated financial statements and related disclosures have been preparedshould be read in conjunction with the assumption that users of the interim financial information have read or have access to theCompany’s audited consolidated financial statements and the related notes thereto included in the 2021 Annual Report on Form 10-K for the year ended March 31,2020 which was filed with the United States Securities and Exchange Commission, (“SEC”), on June 23, 2020.10-K.

Principles of Consolidation

These unaudited condensed consolidated financial statements include the accounts of the Company and the accounts of all of the Company’s subsidiaries. All intercompany balances and transactions have been eliminated in the accompanying financial statements.

9

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES (continued)

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the reporting period. Actual results could differ from those estimates. On an ongoing basis, the Company evaluates its significant estimates including accruals for expenses under consulting, licensing agreements, and clinical trials, stock-based compensation, warrant fair value, assumptions associated with revenue recognition, and the determination of deferred tax attributes and the valuation allowance thereon.

Other Risks and Uncertainties

The Company is subject to risks common to medical device and development stage companies including, but not limited to, new technological innovations, regulatory approval, dependence on key personnel, protection of proprietary technology, compliance with government regulations, product liability, uncertainty of market acceptance of products and the potential need to obtain additional financing. The Company is dependent on third partythird-party suppliers and, in some cases single-source suppliers.

There can be no assurance that the Company’s product will be accepted in the marketplace, nor can there be any assurance that any future products can be developed or manufactured at an acceptable cost and with appropriate performance characteristics, or that such products will be successfully marketed, if at all.

The Company’s products require approval or clearance from the U.S. Food and Drug AdministrationFDA prior to commencingcommencement of commercial sales in the United States. There can be no assurance that the Company’s products will receive all of the required approvals or clearances. Approvals or clearances are also required in foreign jurisdictions in which the Company may license or sell its products. If the Company is denied such approvals or clearances or such approvals or clearances are delayed, it may have a material adverse impact on the Company’s results of operations, financial position and liquidityliquidity. Further, there can be no assurance that the Company’s product will be accepted in the marketplace, nor can there be any assurance that any future products can be developed or manufactured at an acceptable cost and with appropriate performance characteristics, or that such products will be successfully marketed, if at all.

The development of ourthe Company’s product candidates could be further disrupted and adversely affected by a resurgence of the recent outbreak of COVID-19.COVID-19 pandemic. The spread of SARS CoV-2 from China to other countries has resultedCompany experienced significant delays in the Director General ofsupply chain for LungFit®due to the World Health Organization declaring COVID-19 a pandemic on March 11, 2020. We have assessedredundancy in parts and suppliers with ventilator manufacturing which has since been remedied. The Company continuously assesses the impact COVID-19 may have on ourthe Company’s business plans and ourits ability to conduct the preclinical studies and clinical trials as well as on ourthe Company’s reliance on third-party manufacturing and our supply chain. However, there can be no assurance that this analysisthe Company will enable usbe able to avoid part or all of any impact from the spread of COVID-19 or its consequences. The extent to which the COVID-19 pandemic and global efforts to contain its spread will impact our operations will depend on future developments, which are still uncertain and cannot be predicted at this time.

Concentrations

The Company’s license revenue was from two milestone payments fromconsequences if a terminated license see Note 10. The Company is reliant on two vendors for commercial manufacturing of the LungFit™ generator and delivery systems and nitrogen dioxide filters for both clinical studies and commercial supply, if regulatory approval is received. 

resurgence occurs.

 

10

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES (continued)

Financial Instruments

Financial instruments that potentially subjectThe Company considers all highly liquid investments with original maturities of three months or less at the Companydate of purchase and an investment in a U.S. government money market fund to concentrations of credit risk consist principally ofbe cash and cash equivalents and marketable securities.equivalents. The Company maintains its cash and cash equivalents in bank deposit and other interest-bearing accounts in major bankshighly rated financial institutions in Israel, Ireland and the U.S., the balances of which, at times, may exceed federally insured limits.

The Company has no off-balance-sheet concentration of credit risk such as foreign exchange contracts, option contracts or other foreign hedging arrangements.

Restricted Cash

As of June 30, 2020,2021 and March 31, 2021, restricted cash includes $619,000consisted of cash that is $1,019,000 and $619,000 designated for a contract manufacturer.manufacturer, respectively. This cash is expected to be used for material and parts that require a long lead time. Collateral for vehicle leases are invested in bank deposit accounts which is restricted and as of June 30, 2020 was $17,317 and as of March 31, 2020 was $16,836, respectively.

Cash equivalents are short-term highly liquid investments that are readily convertible to cash with original maturities of three months or less at acquisition. Restricted cash is collateral for vehicle leases and invested in bank deposit accounts.

The following table is the reconciliation of the presentation and disclosure of financial instruments as shown on the Company’s consolidated statements of cash flows:

SCHEDULE OF CASH AND CASH EQUIVALENTS AND RESTRICTED CASH

 

June 30, 2020

 

June 30, 2019

  June 30, 2021  June 30, 2020 
Cash and cash equivalents $23,808,900  $636,193  $38,581,386  $23,808,900 
Restricted cash  636,317   16,827   1,046,606   636,317 
Cash and cash equivalents and restricted cash $24,445,217  $653,020 
Total $39,627,992  $24,445,217 

Revenue Recognition

The Company recognizes revenue when we transferit transfers promised goods or services to customers in an amount that reflects the consideration to which we expectthe Company expects to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers we performthe Company performs the following five steps: (i) identify the contract(s) with a customer;customer, (ii) identify the performance obligation(s) in the contract;contract, (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation(s) in the contract;contract, and (v) recognize revenue when (or as) we satisfythe Company satisfies the performance obligation(s). At contract inception, we assessthe Company assesses the goods or services promised within each contract, assessassesses whether each promised good or service is distinct, and identifyidentifies those that are performance obligationsobligations.

11

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES (continued)

The Company must useuses judgment to determine: a) the number of performance obligations based on the determination under step (ii) above and whether those performance obligations are distinct from other performance obligations in the contract; b) the transaction price under step (iii) above; and c) the stand-alone selling price for each performance obligation identified in the contract for the allocation of transaction price in step (iv) above. The Company also uses judgment to determine whether milestones or other variable consideration, except for royalties, should be included in the transaction price. The transaction price is allocated to each performance obligation on an estimated stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied, see, Note 10.

satisfied. Where a portion of non-refundable up-front fees or other payments received are allocated to continuing performance obligations under the terms of a license arrangement, they are recorded as contract liabilities and recognized as revenue when (or as) the underlying performance obligation is satisfied.

11

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES (continued)

Grant receivable

Under a collaboration arrangement with the Cystic Fibrosis Foundation, grant milestones are achieved subject to certain performance steps and requirements under a development program. Grant milestones are recorded as reimbursements against the applicable portion of the Company’s research and development expenses. Such reimbursements are reflected as a reduction of research and development expenses in the Company’s consolidated statements of operations, as the performance of research and development services for reimbursement is not considered to be an ongoing component or central to the Company’s operations.

Segment reportingReporting

Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, we have viewed ourthe Company views its operations and managed ourmanages its business as one 1segment.

Research and Development

Research and development expenses are charged to the statement of operations as incurred. Research and development expenses include salaries, benefits, stock-based compensation and costs incurred by outside laboratories, manufacturer’s,manufacturers, clinical research organizations, consultants, and accredited facilities in connection with clinical trials and preclinical studies and stock based-compensation. Research and development projects that have no alternative uses have been expensed as incurred.expenses are partially offset by the benefit of tax incentive payments for qualified research and development expenditures from the Australian tax authority (“AU Tax Rebates”). The Company does not record AU Tax Rebates until payment is received due to the uncertainty of receipt. To date, the Company has not received any AU Tax Rebates.

12

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES (continued)

Foreign Exchange Transactions

BA Ltd., Beyond Air Ireland Limited, Beyond Air Australia Pty, Ltd.The Company’s subsidiaries have operations are in Israel, Ireland, and in Australia, respectively. Beyond Air’sAustralia. The Company’s operations are in the United States and the Company’s management believes that the U.S. dollar is the currency of the primary economic environment in which the Company operates and expects to continue to operate in the foreseeable future. Thus, the functionalThe Company translated its non-U.S. operations’ assets and reporting currencyliabilities denominated in foreign currencies into U.S. dollars at current rates of exchange as of the Company isbalance sheet date and income and expense items at the U.S. dollar. The Company’s transactions and balances denominated in U.S. dollars are presented at their original amounts. Non-dollar transactions and balances have been re-measured to U.S. dollars in accordance withaverage exchange rate for the Accounting Standards Board Codification Topic 830, “Foreign Currency Matters”. The translation adjustment atreporting period. Translation adjustments resulting from exchange rate fluctuations as of June 30, 20202021 and March 31, 2020 was2021 were not material. Gains or losses from foreign currency transactions are included in other income (expense) in the statement of operations as foreign currency exchange gain/(loss).

Stock-Based Compensation

The Company measures the cost of employee and non-employee services received in exchange for an award of equity instruments based on the grant-dategrant date fair value of the award. Fair value for restricted stock awards is valued using the closing price of the Company’s common stock on the date of grant. That costThe grant date fair value is recognized over the requisite service period during which an employee and non-employee is required to provide service in exchange for the award - the requisite service period.award. The grant-dategrant date fair value of employee and non-employee share options is estimated using the Black-Scholes option pricing model. The risk-free interest rate assumptions were based upon the observed interest rates appropriate for the expected term of the equity instruments. The expected dividend yield was assumed to be zero as the Company has not paid any dividends since its inception and does not anticipate paying dividends in the foreseeable future. Due to the Company’s limited trading history, the Company utilizes anweighting of its historical volatility and the implied volatility based on an aggregate of guideline companies. In 2020, the Company began to blend its historical volatility with the peer group in order to obtain expected volatility. The peer companies were based similar publicly traded peer companies. The Company routinely reviews its calculation of volatility based on, the Company’s life cycle, its peer group, and other factors. The Company uses the simplified method for share-based compensation to estimate the expected term.

12

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES (continued)

Compensation expense for options and warrants granted to non-employees is determined by the fair value of the consideration received or the fair value of the equity instruments issued, whichever is more reliably measured, and is recognized over the service period. The expense was previously adjusted to fair value at the end of each reporting period until such awards vested, and the fair value of such instruments, as adjusted, was expensed over the related vesting period. Adjustments to fair value at each reporting date resulted in income or expense, depending upon the estimate of fair value and the amount of expense recorded prior to the adjustment. In June 2018, the FASB issued ASU No. 2018-07, Stock-based Compensation: Improvements to Nonemployee Share-based Payment Accounting, which amends the existing accounting standards for share-based payments to nonemployees. This ASU aligns much of the guidance on measuring and classifying nonemployee awards with that of awards to employees. Under the new guidance, the measurement of nonemployee equity awards is fixed on the grant date. The fair value of all non-employee awards became fixed at the start of the fourth quarter of 2019.

Property and Equipment

Property and equipment are stated at cost less accumulated depreciation and accumulated amortization. Depreciation and amortization is calculated using the straight-line method over the estimated useful life of the assets as follows:

SCHEDULE OF PROPERTY AND EQUIPMENT USEFUL LIFE OF ASSETS

ComputersComputer equipmentThree years
Furniture and fixturesSeven years
Clinical and medical equipmentFive andor Fifteen years or estimated useful life of the asset
Leasehold improvementsShorter of term of lease or estimated useful life of the asset

13

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES (continued)

Licensed Right to Use Technology

Licensed right to use technology that is considered platform technology with alternative future uses is recorded as an intangible asset which resulted from the NitricGen transaction, see Note 11. The intangible asset was valued based upon the fair value of the options issued to NitricGen and the cash paid for this transaction. The license also contains two future milestone additional payments aggregating $1,800,000. The intangible asset is being amortized on a straight-line method over its estimated useful life, of determined to be thirteen years. years, see Note 14.

The expected amortization expense for the next five years and thereafter is as follows for the year ended March 31:31,:

Remainder of 2021 $28,558 
2022  38,077 
2023  38,077 
2024  38,077 
2025  38,077 
Thereafter  222,378 
Total $403,244 

13

BEYOND AIR, INC. AND ITS SUBSIDIARIESSCHEDULE OF FUTURE EXPECTED AMORTIZATION EXPENSE

   March 31, 2021 
Remainder of 2022 $28,558 
2023  38,077 
2024  38,077 
2025  38,077 
2026  38,077 
Thereafter  184,292 
Total $365,158 

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)Long-Lived Assets

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES (continued)

The Company assess the impairment of long-lived assets on an ongoing basis and whenever events or changes in circumstances indicate that the carrying value may not be recoverable. Factors we consider that could triggerthe Company considers as potential triggers of an impairment review include the following:

significant underperformance relative to expected historical or projected future operating results,
significant changes in the manner of ourthe Company’s use of the acquired assets or the strategy for ourits overall business,
significant negative regulatory or economic trends, and
significant technological changes, which would render the platform technology, equipment, and manufacturing processes obsolete.

14

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES (continued)

Long-Lived Assets

Recoverability of assets that will continue to be used in ourthe Company’s operations is measured by comparing the carrying value to the future net undiscounted cash flows expected to be generated by the asset or asset group. Future undiscounted cash flows include estimates of future revenues, driven by market growth rates, and estimatedestimates of future costs. There were no events during the reporting periods that were deemed to be a triggering event that would require an impairment assessment.

Income Taxes

The Company accounts for income taxes using the asset and liability method. Accordingly, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in the tax rate is recognized in income or expense in the period that the change is effective. Tax benefits are recognized when it is probable that the deduction will be sustained. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will either expire before the Company is able to realize the benefit, or that future deductibility is uncertain. As of June 30, 2020,2021 and March 31, 2020,2021, the Company recorded a valuation allowance to the full extent of ourthe Company’s net deferred tax assets since the likelihood of realization of the benefit does not meet the more likely than notmore-likely-than-not threshold.

The Company files a U.S. Federal,federal, various state, and Internationalinternational income tax returns. Uncertain tax positions are reviewed on an ongoing basis and are adjusted in light of changing facts and circumstances. Such adjustment is reflected in the tax provision when appropriate. The Company will recognize interest and penalties, if any, related to unrecognized tax benefits in income taxes in the statements of operations. Tax years 20162017 through 20202021 remain open to examination by federal and state tax jurisdictions. The Company files tax returns in Israel for which tax years 20142015 through 20202021 remain open. In addition, the Company files tax returns in Ireland and Australia and the tax yearyears 2020 remainsand 2021 remain open.

14

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES (continued)

Net Income (Loss) Per Share

Basic and diluted net loss per share attributable to common stockholders is computed by dividing the net loss and a deemed dividend from a warrant modification attributable to common stockholders, if any, by the weighted average number of shares of common sharesstock outstanding for the period. The dilutive effect of outstanding options, warrants, restricted stock and other stock-based compensation awards is reflected in diluted net income (loss) per share by application of the treasury stock method. The calculation of diluted net income (loss) attributed to common shareholdersstockholders per share excludes all anti-dilutive shares of common shares.stock. For periods in which the Company has reported net losses, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders, because such shares of common sharesstock are not assumed to have been issued if their effect is anti-dilutive, see Note 9.

15

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES (continued)

New Accounting Standards

There are no recently issued accounting standards that have been adopted in the current period or will be adopted in future periods that have had or are expected to have a material impact on ourthe Company’s consolidated financial position or results of operations.

Recently Issued Accounting Standards Not Yet Adopted

In December 2019, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2019-12, “Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes.” as part of its initiative to reduce complexity in the accounting standards. The standard eliminates certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The standard also clarifies and simplifies other aspects of the accounting for income taxes. The standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. Early adoption is permitted. The Company does not anticipate the adoption of this guidance to have a material impact on its consolidated financial statements and related disclosures.

NOTE 3 FAIR VALUE MEASUREMENT

The Company’s financial instruments primarily include cash, cash equivalents, restricted cash, marketable securities, accounts payable, loan payable and credit facilitythe short-term loan. Due to the short-term nature of cash and accounts payable,these financial instruments, the carrying amounts of these assets and liabilities approximate their fair value. The long-term debt approximates fair value due to the prevailing market conditions for similar debt with remaining maturity and terms.

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value. A fair value hierarchy has been established for valuation inputs that gives the highest priority to quoted prices in active markets for identical assets or liabilities and the lowest priority to unobservable inputs. The fair value hierarchy is as follows:

Level 1 -quoted prices in active markets for identical assets or liabilities;
Level 2 -inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; or
Level 3 -unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

1516

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 4 PROPERTY AND EQUIPMENT

Property and equipment consist of the following as of June 30, 2020 and March 31, 2020, respectively:following:

  June 30, 2020  March 31, 2020 
       
Clinical and medical equipment $562,024  $357,795 
Computer equipment  91,999   73,982 
Furniture and fixtures  62,995   53,895 
Leasehold improvements  17,517   5,336 
   734,535   491,008 
Accumulated depreciation and amortization  (313,321)  (279,671)
  $421,214  $211,337 

SCHEDULE OF PROPERTY AND EQUIPMENT

  June 30, 2021  March 31, 2021 
       
Clinical and medical equipment $1,097,397  $1,074,353 
Computer equipment  153,123   152,052 
Furniture and fixtures  136,110   133,170 
Leasehold improvements  21,840   21,840 
   1,408,470   1,381,415 
Accumulated depreciation and amortization  (510,920)  (452,573)
  $897,550  $928,842 

Depreciation and amortization expense related to fixed assets for the three months ended June 30, 20202021 and June 30, 20192020 was $33,650 $58,347 and $17,902.$33,650, respectively.

17

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 5 SHAREHOLDER’SSTOCKHOKDERS’ EQUITY

In August 2018, the Company entered into a Stock Purchase Agreement with LPC for $20 million. The Company may sell and issue LPC and LPC was obligated to purchase up to $20 million in value of shares of common stock from time to time over three years. Under this Purchase Agreement, for the three months ended June 30, 2020 and June 30, 2019, the Company received proceeds of $ 1,958,845 and $1,173,810 from the sale of 243,605 and 250,000 shares of the Company’s stock, respectively. The average price per share sold for the three months ended June 30, 2020 and June 30, 2019 was $8.04 per share and $4.70 per share, respectively. On May 14, 2020, the Company entered into a $40 million NewStock Purchase Agreement, which replaced the former $20 million purchase agreement with LPC that replaced the existing $20 million purchase agreement.from August 2018. The NewStock Purchase Agreement provides for the issuance of up to $40 $40 million of the Company’s common stock which wethe Company may sell from time to time in ourits sole discretion to LPC over the next 36 months, provided that the closing price of the Company’s common stock is not below $0.25 $0.25 per share and subject to certain other conditions and limitations set forth in the NewStock Purchase Agreement. Pursuant toFor the New Purchase Agreement,three months ended June 30, 2021 and June 30 2020, the Company received net proceeds of $1,682,835 $1,031,300 and $3,641,800 from the sale of 325,000 share200,000 and 568,605 shares of common stock, at $8.58 per share. The Company incurred a 2.5% fee for this transaction. Atrespectively. As of June 30, 2020,2021, there is $37,211,500was $28.2 million available under thisthe Stock Purchase Agreement. The Company filed a prospectus supplement for this Purchase Agreement.

On April 2, 2020, the Company entered into an At-The-Market Equity Offering (“ATM”)ATM for $50 $50 million utilizing the Company’s shelf registration statement and filed on Form S-3. The Under the ATM, the Company may sell shares of ourits common stock having aggregate sales proceeds of up to $50,000,000$50 million from time to time in this offering,and at various prices, subject to the conditions and limitations set forth in the sales agreement. If shares of the Company’s common stock are sold, there is a three 3 percent fee paid to the sales agent. For the three months ended June 30, 2021 and June 30, 2020, the Company received net proceeds of $899,540 $7,481,567 and $899,540 from the sale of 1,239,405 and 113,712 shares of the Company’s stock. At June 30, 2020, there is $48,985,459, available under this ATM.

16

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 5 SHAREHOLDER’S EQUITY (continued)

On June 3, 2019, the Company entered into a Stock Purchase Agreement (“Offering”) with investors for the issuance of 1,583,743 shares of common stock. The Company raised net proceeds was $7,839,495. The Company’s CEO participated in this offering and invested $300,000 and received 58,253 shares of common stock, or $5.15 per share.

On July 2, 2019, the SEC declared effective, the Company’s Form S3 shelf registration statement which allows the Company to sell up to $100 million of equity securities. In addition, certain directors and employees invested $610,000 for an aggregate of 118,254 shares of common stock, representing a purchase price of $5.15 per share. The Company registered these shares in June 2019 on Form S-3 and was declared effective on September 11, 2019.

Stock to be Issued to a Vendor

As of March 31, 2020, the Company was obligated to issue 30,000 shares to a vendor for services related to investor relations. In May 2020, the 30,000 shares were issued and the fair value of the liability amount was transferred to shareholders’ equity. For the three months ended June 30, 2020 and June 30, 2019 the Company recorded the fair market value of the shares to be issued and recorded stock-based compensation of $2,100 and $22,500, respectively. The fair market value of the liability asAs of June 30, 2020 and March 31, 20202021, there was $0 and $240,000, respectively.$29.9 million available under the ATM.

Issuance of Restricted SharesStock

On December 26, 2018, and December 31, 2019, the Board of directors approved the issuance of 340,000 and 390,000, shares of restricted stock, respectively, to officers, employees and consultants and theThe fair value for the restricted stock awards was valued at the closing price of the Company’s common stock on the date of grant. Restricted stock vests annually over five years. The fair market value of the restricted shares for stock-based expense is equalyears. Stock-based compensation related to the closing pricing of the Company’sthese stock at the date of grant. Stock based compensationissuances for the three months ended June 30, 20202021 and June 30, 20192020 was $393,861 $158,504 and $151,131,$393,861, respectively. AsA summary of the change of the Company’s restricted stock awards for the period ended June 30, 2020, there are 646,800 unvested shares with an average grant date fair value of $4.99 per share.2021 is as follows:

SCHEDULE OF CHANGE IN WARRANTS OPTIONS

  Number Of Shares  Weighted Average Grant Date Fair Value 
       
Unvested as of April 1, 2021  554,200  5.07 
Forfeited  

(8,000

)  

5.23

 
Unvested as of June 30, 2021  

546,200

  $

5.07

 

Stock Option Plan

The Company’s amendedThird Amended and restatedRestated 2013 Equity Incentive Option Plan (the “2013 Plan”), allows for awards to officers, directors, employees, and non-employeesconsultants of stock options, restricted stock units and restricted shares of the Company’s common stock. The vesting terms of the options issued under the 2013 Plan are generally between two to four years and expire up toexpires in ten years afterfrom the grant date.date. The 2013 Plan has 4,100,000 5,600,000 shares eligibleauthorized for issuance. As of June 30, 2020, there are 69,0472021 484,074 shares were available under the 2013 Plan.

1718

 

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 5 SHAREHOLDER’SSTOCKHOLDERS’ EQUITY (continued)

A summary of the Company’s options for the three months ended June 30, 2020,2021, is as follows:

  

Number

Of Options

  

Weighted
Average
Exercise

Price -
Options

  Weighted
Average
Remaining
Contractual
Life-
Options
�� Aggregate
Intrinsic
Value
 
             
Options outstanding as of April 1, 2020  3,053,589  $4.48   8.4  $2,931,535 
Granted  122,000   5.76   9.9   219,000 
Exercised  (2,340)  0.1       (18,400)
Outstanding as of June 30, 2020  3,173,249  $4.77   8.5  $7,790,295 
Exercisable as of June 30, 2020  1,302,374  $4.48   7.8  $6,633,700 

SCHEDULE OF OPTION ACTIVITY

  

Number

Of Options

  

Weighted

Average

Exercise

Price -

Options

  

Weighted

Average

Remaining

Contractual

Life-

Options

  

Aggregate

Intrinsic

Value

 
             
Options outstanding as of April 1, 2021  4,185,097  $4.91   8.4  $2,609,100 
Granted  65,000   5.26         
Forfeited  (25,875)  5.11         
Outstanding as of June 30, 2021  4,224,222  $4.93   8.0  $6,516,900 
Exercisable as of June 30, 2021  1,901,479  $4.57   7.0  $3,597,100 

As of June 30, 2020,2021, the Company has unrecognized stock-based compensation expense of approximately $3,845,100 $5,554,700 related to unvested stock options and which is expected to be expensed over the weighted average remaining service period of 2.6 2.4 years. The weighted average fair value of options granted was $5.09 $4.05 and $5.09 per share during the three months ended June 30, 2020.2021 and June 30, 2020, respectively. The following were utilized on the date of grant:

  June 30, 2020  June 30, 2019 
Risk -free interest rate  0.5-.07%  2.3%
Expected volatility  87.8-92.54%  83.4%
Dividend yield  0%  0%
Expected terms (in years)  5.28 -6.25   6.25 

SCHEDULE OF ASSUMPTION OF BLACK-SCHOLES OPTION PRICING MODEL

  June 30, 2021  June 30, 2020 
Risk free interest rate  1.1%  0.5-.07%
Expected volatility  91.1-91.8%  87.8-92.5%
Dividend yield  0%  0%
Expected terms (in years)  6.25   5.28 -6.25 

The following summarizes the components of stock-based compensation expense which includesinclude stock options and restricted stock for the three months ended June 30, 20202021 and June 30, 2019,2020, respectively

  Three Months Ended
June 30, 2020
  

Three Months Ended

June 30, 2019

 
       
Research and development $      837,449  $149,922 
General and administrative  978,205   769,115 
         
Total stock-based compensation expense $1,815,654  $919,037 

WarrantsSCHEDULE OF STOCK-BASED COMPENSATION EXPENSE

  

Three Months Ended

June 30, 2021

  

Three Months Ended

June 30, 2020

 
       
Research and development $364,551  $837,449 
General and administrative  851,360   978,205 
         
Total $1,215,911  $1,815,654 

On March 4, 2021, the stockholders approved the 2021 Employee Stock Purchase Plan “the ESPP”. The purpose of the ESPP is to encourage and to enable eligible employees of the Company, through after-tax payroll deductions, to acquire proprietary interests in the Company through the purchase and ownership of shares of common stock. The ESPP is intended to benefit the Company and its stockholders by (a) incentivizing participants to contribute to the success of the Company and to operate and manage the Company’s business in a manner that will provide for the Company’s long-term growth and profitability and that will benefit its stockholders and other important stakeholders and (b) encouraging participants to remain in the employ of the Company. As of June 30, 2021 and March 31, 2021, there were 0shares issued under the ESPP and 750,000 shares were available for future issuance under the ESPP.

Warrants

A summary of the Company’s outstanding warrants as of June 30, 2020 are2021 is as follows:

Warrant Holders Number Of Warrants  Exercise Price  Date Of Expiration  
January 2017 offering - investors  1,530,282  $3.66  January 2022 (a)
January 2017 offering - investors  1,530,282  $3.66  February 2022 (a)
March 2017 offering - investors  68,330  $3.66  March 2021 (a)
March 2017 offering - placement agent  7,541  $3.66  March 2021 (a)
March 2018 offering - investors  1,586,231  $4.25  March 2022  
Third-party license agreement  208,333  $4.80  January 2024  
March 2020 loan (see Note 10)  172,187  $7.26  March 2025   
Total  5,103,186         

SUMMARY OF COMPANY’S OUTSTANDING WARRANTS

Warrant Holders 

Number Of

Warrants

  

Exercise

Price

  

Date of

Expiration

January 2017 offering – investors  2,977,232  $3.66  January 2022 (a)
March 2017 offering – investors  68,330  $3.66  March 2022 (a)
March 2017 offering - placement agent  7,541  $3.66  March 2022 (a)
Third-party license agreement  208,333  $4.80  January 2024
March 2020 loan (see Note 12)  172,187  $7.26  March 2025
Total  3,433,623       

(a)These warrants have down round protection.

For the three months ended June 30, 2021, 0warrants were exercised. For the three months ended June 30, 2020, there were 70,538 warrants exercised for $293,111 and 70,538 shares of common stock were issued at an average price per share of $4.16 per share. For the year three months ended June 30, 2019, no warrants were exercised.$293,111.

1819

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 6 OTHER CURRENT ASSETS PREPAID EXPENSES

A summary of current assets and prepaid expenses as of June 30, 2020 and March 31, 2020 is as follows:

  June 30, 2020  March 31, 2020 
Research and development $667,214  $266,510 
Insurance  337,574   471,182 
Professional  50,000   156,259 
Value added tax receivable  79,759   124,127 
Other  72,691   131,728 
  $1,207,238  $1,149,806 

SCHEDULE OF CURRENT ASSETS AND PREPAID EXPENSES

  June 30, 2021  March 31, 2021 
Research and development $284,276  $271,727 
Insurance  573,928   971,140 
Professional  113,056   - 
Value added tax receivable  106,210   41,272 
Other  247,594   245,957 
Total $1,325,064  $1,530,096 

NOTE 7 ACCRUED EXPENSES

A summary of the accrued expenses as of June 30, 2020 and March 31, 2020 is as follows:

  June 30, 2020  March 31, 2020 
Vendors – research and development $256,578  $484,756 
Professional fees  447,673   476,638 
Employee salaries and benefits  145,273   71,066 
Interest expense  126,928   - 
Other  108,152   65,074 
Total $1,084,604  $1,097,534 

SUMMARY OF ACCRUED EXPENSES

  June 30, 2021  March 31, 2021 
Research and development $446,877  $584,802 
Professional fees  710,549   708,800 
Employee salaries and benefits  398,653   269,787 
Other  139,156   241,549 
Total $1,695,235  $1,804,938 

NOTE 8 LEASES

On April 1, 2019, the Company early adopted Accounting Standards UpdateASU No. 2016-02, Leases (Topic 842) (ASU 2016-02), as amended (“ASU 2016-02”), which generally requires lessees to recognize operating and financing lease liabilities and corresponding right-of-use assets on the balance sheet and to provide enhanced disclosures surrounding the amount, timing and uncertainty of cash flows arising from leasing arrangements. The Company early adopted the new guidance using the modified retrospective transition approach and practical expedients to all leases existing at the date of initial application and not restating comparative periods. In June, the Company entered into a new lease and cancelled a lease, which resulted recognition of operating lease liabilities and right-of-use assets of approximately of $236,700 and $236,900, respectively The cancellation of the lease resulted in a derecognition of operating lease liabilities and right-of-use assets of approximately of $17,600 and $20,500. As a result of the cancellation, the Company recorded a gain of $1,900. The right-of use assets and operating lease liability isare as follows as of June 30, 2020 and March 31, 2020.follows:

  June 30, 2020  March 31, 2020 
       

Right- of- use assets

 $398,102  $195,727 
         
Operating lease liability short-term $79,668  $69,342 
Operating lease liability long-term  323,270   131,581 
  $402,938  $200,923 

SCHEDULE OF OPERATING LEASE LIABILITY

  June 30, 2021  March 31, 2021 
       
Right-of-use assets $1,815,351  $1,860,885 
         
Operating lease liability short-term $187,288  $113,141 
Operating lease liability long-term  1,720,389   1,789,461 
Total $1,907,677  $1,902,602 

Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected remaining lease term. Certain adjustments to the right-of-use asset may be required for items such as prepaid or accrued rent. The interest rate implicit in ourthe Company’s leases is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. In transition to ASC 842, the Company utilized the remaining lease term of its leases in determining the appropriate incremental borrowing rates. At June 30, 2020 and March 31,2020, the weighted average discount rate and remaining term on lease obligation is approximately, 8.3%, 8.3%, 4.7 and 3.0 years respectively at. Operating lease expense is recognized on a straight-line basis over the lease term and is included in general and administrative expenses. Amortization expense for finance (capital) leases is recognized on a straight-line basis over lease term and is included in general and administrative expenses and research development expenses. The Company has other operating lease agreements with commitments of less than one year or that are not significant. The Company elected the practical expedient option and development expenses, while interest expense for finance leases is recognized using the effective interest method.as such these lease payments are expensed as incurred.

SCHEDULE OF LEASE OTHER INFORMATION

Other Information For The Three Months Ended June 30, 2021   
Cash paid for amounts included in the measurement of lease liabilities:    
Cash paid $31,861 
Right-of-use assets obtained in exchange for new operating lease liabilities:  - 
Weighted average remaining lease term — operating leases  9.0 years 
Weighted average discount rate — operating leases  8.3%

 SCHEDULE OF MATURITY OF LEASE LIABILITIES

Maturity of Lease Liabilities Operating Leases 
Payments remaining for the year ended March 31:    
2022 $234,332 
2023  328,475 
2024  286,786 
2025  277,451 
2026  284,590 
Thereafter  1,328,640 
Total lease payments  2,740,274 
Less: interest  (832,597)
Present value of lease liabilities $1,907,677 

1920

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 9 BASIC AND DILUTED NET INCOME (LOSS) PER COMMON SHARE

The following potentially dilutive securities were not included in the calculation of diluted net income (loss) per share attributable to common stockholders because their effect would have been anti-dilutive for the periods presented:

  

June 30, 2020

  

June 30, 2019

 
       
Common stock warrants  5,103,186   6,143,405 
Common stock options  3,173,249   2,339,215 
Restricted shares  646,800   340,000 
         
Total  8,923,235   8,822,620 

SCHEDULE OF POTENTIAL ANTI-DILUTIVE SECURITIES

  June 30, 2021  June 30, 2020 
       
Common stock warrants  3,433,623   5,103,186 
Common stock options  4,224,222   3,173,249 
Restricted stock  546,200   646,800 
         
Total  8,204,045   8,923,235 

NOTE 10 LICENSE AGREEMENT

On January 23, 2019, the Company entered into an agreement for commercial rights (the “License“Circassia Agreement”) with Circassia Limited and its affiliates (collectively, “Circassia”) for persistent pulmonary hypertension of the newborn (“PPHN”)PPHN and future related indications at concentrations of <80 ppm in the hospital setting in the United States and China. On December 18, 2019, the Company terminated the License Agreement,Circassia Agreement. On May 25, 2021, the Company made a settlement with Circassia, see Note 13. The14.

As of March 31, 2021, the Company would have received payments up to $32.55 million in up fronthas met its performance obligation under the Circassia Agreement and regulatory milestones,revenue therefrom has been previously recognized. License revenue of which $31.5 million was $0 and $229,161 associated with the U.S. market. All such payments were payable in cash or ordinary shares of Circassia, atCompany’s second performance obligation has been recognized for the discretion of Circassia, with payments in cash discounted by approximately 5%. Royalties are payable only in cash.three months ended June 30, 2021 and June 30, 2020, respectively.

This contract was evaluated under ASC 606, which was adopted by the Company during fiscal 2019. Based upon the evaluation, it was determined that the contract consists of five performance obligations with only the following two obligations required prior to the termination of the License Agreement.

Performance Obligation 1: non-exclusive transfer of functional intellectual property rights to Circassia, which includes:21

 the consummation of the License Agreement, which included significant pre-agreement negotiation, product specification, and
the successful completion of the pre-submission meeting with the FDA. At this meeting the FDA reinforced their assessment of the LungFit™ PH as a medical device and the requirements for approval.

Performance Obligation 2: ongoing support associated with the PMA submission and regulatory approval by the FDA. This also includes development activities including manufacturing readiness process ahead of the approval.

20

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 11 GRANT COLLABORATON AGREEMENT

On February 10, LICENSE AGREEMENT (continued)

In consideration2021, the Company received a grant for up to $2.17 million from the Cystic Fibrosis Foundation (“CFF”) to advance the clinical development of high concentration NO for the treatment of Nontuberculous Mycobacteria, or NTM pulmonary disease, which disproportionally affects cystic fibrosis (“CF”) patients. Under the terms of the rights and licenses granted to Circassia bygrant agreement, the Company, five milestones were included. The Company received the first two milestone payments in ordinary shares of Circassia

$7.35 million or 12,300,971 ordinary shares of Circassia upon signing (received in quarter four of fiscal year ended March 31, 2019);
$3.15 million or 5,271,844 ordinary shares of Circassia payable within five (5) business days following the successful completion of a Food and Drug Administration (the “FDA”) pre-submission meeting (received in quarter four of fiscal year ended March 31, 2019);

During the three months ended March 31, 2019, the Company met the first two milestones under the license agreement and received 17,572,815 ordinary shares valued at $9,987,295. This consideration wasfunding will be allocated to the first twoongoing LungFit® GO NTM pilot study. The grant provides milestones based upon the Company’s achieving performance obligations. one beingsteps and requirements under a development program. The grant provides for royalty payments to CFF upon the transfercommercialization of any product developed under the intellectual property to Circassia, which was recognizedgrant program at a point in time and was valuedrate of 10% of net sales. The royalties are capped at $7,116,232 andfour times the other beinggrant actually paid to the ongoing support associated with the PMA submission and regulatory approval by the FDA, which was valued at $2,871,063 and recorded as deferred revenue to be recognized over a period of time from the commencement of the agreement to when management expects to submit the PMA.Company. For the three months ended June 30, 20202021, the Company recognized $225,150 in reduction of research and June 30, 2019, $229,161development expenses and $627,469, respectively incurred $392,000 of such revenue associated with this second performance obligation has been recognized. As of June 30, 2020,related research and March 31, 2020, deferred revenue was $644,029 and $873,190, respectively.development costs.

21

BEYOND AIR, INC. AND ITS SUBSIDIARIESNOTE 12 LONG-TERM LOAN

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED

NOTE 11 FACILITY AGREEMENT LOAN

On March 17, 2020, the Company entered into a facility agreement the Facility Agreement for up to $25,000,000 with certain lenders pursuant to which the lenders shall loan to up to $25,000,000 in five tranches of $5,000,000 $5,000,000 per tranchetranche. Such tranches are at the option of the Company (“Tranches”), provided, however that the Company may only utilize tranches three through five following FDA approval of our the LungFit™LungFit® PH product. The loan(s) are unsecured with interest at 10%10% per year which is to be paid quarterly. The loans may be prepaid with certain prepayment penalties. The effective interest rate for this loan is 13.3%13.3% per year. Each tranche shall be repaid in installments commencing June 15, 2023 with all amounts outstanding under any tranche due on March 17, 2025. The Company received proceeds from the first tranche in fiscal year 2020. A lender who is over a five percent shareholder,stockholder loaned the Company $3,160,000$3,160,000 of the first tranche and, as such, related party interest expense associated with this debt for the three months ended June 30, 2021 and June 30, 2020 was $79,000 (not$79,000 and $79,000 (not including amortization of debt discount and deferred offering costs). , respectively.

In connection with the first tranche, the Company issued, in March 2020, warrants to the lenders for the purchase of 172,826 shares of the Company’s common stock at $7.26 $7.26 per share. The warrants expire in five years.years. There are additional warrant issuances associated with each tranche. If the second tranche of $5 million is utilized by the Company, the warrants that will be issued isare up to twenty five percentagepercent of itstheir commitment value divided by the five day the volume weighedfive-day volume-weighted average price “(VWAP”(“VWAP”) prior to utilization date. For tranches three to five, if any of these tranches are utilized by the Company, the warrants that will be issued isare up to ten percentagepercent of its commitment value divided by the five day thefive-day VWAP.As a result, theThe Company allocated the fair market value of the warrants at the date of grant of the warrant to stockholders’ equity and reflected a debt discount valued at $594,979 usingof $594,979. Debt discount and debt issuance costs are amortized over the Black Scholes pricing model. 

As a result, the Company allocated the fair market value at the date of grantlife of the warrant to stockholders’ equity and debt discount valued at $594,979. The Black-Scholes pricing model was used with the following assumptions:loan.

Expected term in years225.0
 
Volatility87.5%
Dividend yield0.0%
Risk-free interest rate0.7%

BEYOND AIR, INC. AND ITS SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 12 LONG-TERM LOAN (continued)

A summary of the facility agreementlong-term loan balance as of June 30, 2020 and March 31, 2020 is as follows:

  June 30, 2020  March 31, 2020 
Face value of loan $5,000,000  $5,000,000 
Debt discount  (594,979)  (594,979)
Accretion of interest expense  37,754   4,562 
Debt offering costs  (70,518)  (70,518)
Facility agreement loan balance – March 31, 2020 $4,372,257  $4,339,065 

Maturity of Facility Agreement Loan June 30, 2020 
    
2021 $- 
2022  - 
2023  1,500,000 
2024  2,750,000 
2025  750,000 
Total $5,000,000 

SCHEDULE OF LONG-TERM LOAN

  June 30, 2021  March 31, 2021 
Face value of loan $5,000,000  $5,000,000 
Debt discount  (594,979)  (594,979)
Accretion of debt discount  156,685   123,493 
Amortization of debt offering costs  14,750   14,750 
Debt offering costs  (71,063)  (71,063)
Total $4,505,393  $4,472,201 

SCHEDULE OF MATURITY OF LONG-TERM LOAN

Maturity of Long-Term Loan June 30, 2021 
    
2022 $- 
2023  500,000 
2024  2,250,000 
2025  2,250,000 
Total $5,000,000 

NOTE 12 13 LOAN PAYABLE

As of June 30, 2020,2021 and March 31, 2020,2021 in connection with the Company’s insurance policy, a loan was used to finance part of the premium. The following details concerning each loan is due within the year with monthly payments of $42,366 bearing interest at 4.3%. The outstanding balanceare as of June 30, 2020 and March 31, 2020 was $209,579 and $335,358, respectively.follows:

22

BEYOND AIR, INC. AND ITS SUBSIDIARIESSCHEDULE OF LOAN PAYABLE

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

  June 30, 2021  March 31, 2021 
       
Amount outstanding $349,165  $556,514 
Monthly payments $70,396  $70,396 
Number of monthly payments  9   9 
Interest rate  3.2%  3.2%
Due date  November 2021   November 2021 

NOTE 13 14 COMMITMENTS AND CONTINGENCIES

License and Other Agreements

On October 22, 2013, the Company entered into a patent license agreement (the “CareFusion Agreement”) with SensorMedics Corporation, a subsidiary of CareFusion Corp. (“CareFusion”), pursuant to which itthe Company agreed to pay to the third partyCareFusion a non-refundable upfront fee of $150,000$150,000 that is credited against future royalty payments, and is obligated to pay 5%5% royalties of any licensed product net sales, but at least $50,000$50,000 per annum throughduring the term of the agreement and the advance is credited against future royalties payments.agreement. As of December 31, 2019,June 30, 2021, the Company didhas not paypaid any royalties to CareFusion since the Company didhas not havereceived any revenues from this license.the technology associated with the license under the CareFusion Agreement. The term of the agreementCareFusion Agreement extends through the life of applicable patents and may be terminated by either party with 60 days’ prior written notice in the event of a breach of the agreement,CareFusion Agreement, and may be terminated unilaterally by CareFusion with 30 days’ prior written notice in the event that we dothe Company does not meet certain milestones.

In August 2015, BA Ltd. entered into an Option Agreement (the “Option Agreement”) with Pulmonox whereby BA Ltd. acquired the option to purchase certain intellectual property assets and rights (the “Option”) on September 7, 2016 for $25,000.rights. On January 13, 2017, the Company exercised the Option and paid $500,000.$500,000 to Pulmonox. The Company becomes obligated to make certain one-time development and sales milestone payments to Pulmonox, commencing with the date on which we receivethe Company receives regulatory approval for the commercial sale of the first product candidate qualifying under the agreement.Option Agreement. These milestone payments are capped at a total of $87 $87 million across three separate and distinct indications that fall under the agreement,Option Agreement, with the majority of them, approximately $83 $83 million, being related to sales related based on cumulative sales milestones for each of the three products.

On January 31, 2018, the Company and NitricGen, Inc. (“NitricGen”) entered into an agreement (“(the “NitricGen Agreement”) with NitricGen, Inc. (“NitricGen”)to acquire a global, exclusive, transferable license and associated assets including intellectual property, know-how, trade secrets and confidential information from NitricGen related to the LungFit™LungFit®. The Company acquired the licensing right to use the technology and agreed to pay NitricGen a total of $2,000,000 $2,000,000 in future payments based upon achievingthe achievement of certain milestones, as defined in the NitricGen Agreement, and royalties on sales LungFit™of LungFit®. The Company paid NitricGen $100,000 $100,000 upon the execution agreement, $100,000 of the NitricGen Agreement, $100,000 upon achieving the next milestone and issued 100,000 optionswarrants to purchase the Company’s common stock valued at $295,000 $295,000 upon executing the agreement.NitricGen Agreement. The remaining future milestone payments are $1,800,000 $1,800,000 of which $1,500,000 in$1,500,000 is due after six months after the first approval of the LungFit™ by the Food and Drug Administration or the European Medicine Evaluation Agency. approval.

Employment Agreements

Certain officer agreements between the Company and its officers contain a change of control provision for payment of severance arrangements.

Operating LeasesSupply Agreement and Purchase Order

The Company cancelled a lease in May 2020 for its location in Madison, Wisconsin. In JuneAugust 2020, the Company entered into a leasesupply agreement expiring on December 31, 2024. The agreement will renew automatically for office spacesuccessive three-year periods unless and research facility in Madison, Wisconsin. The lease agreement expires in May 2026.

In May 2018,until the Company entered into an operating lease for office space in Garden City, New York.provides twelve months’ notice of intent not to renew. In July 2020, the Company placed a non-cancellable purchase order and the outstanding amount remaining under the purchase order as of June 30, 2021 is approximately $1,054,000 with this supplier.

23

BEYOND AIR, INC. AND ITS SUBSIDIARIESContingencies

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

NOTE 13 COMMITMENTS AND CONTINGENCIES (continued)

The Company has other operating lease agreements with commitments of less than one year or that are not significant. The Company elected the practical expedient option and as such these lease payments are expensed as incurred.

Other Information For The Three Months Ended June 30, 2020   
Cash paid for amounts included in the measurement of lease liabilities:    
Cash paid $19,016 
Right-of-use assets obtained in exchange for new operating lease liabilities:  - 
Weighted-average remaining lease term — operating leases  4.7 years 
Weighted-average discount rate — operating leases  8.3%

Maturity of Lease Liabilities 

Three months ended

June 30,

 
 Operating Leases 
2021(excluding the three months ended June 30, 2020) $82,076 
2022  111,462 
2023  114,114 
2024  66,689 
2025  51,418 
Thereafter  

61,207

 
Total lease payments  486,966 
Less: interest  (84,028)
Present value of lease liabilities $402,938 

Contingencies

On March 16, 2018, Empery Asset Master, Ltd., Empery Tax Efficient, LP and Empery Tax Efficient II, LP, (collectively, “Empery”), filed a complaint in the NY Supreme Court of the State of New York,(the “NY Supreme Court”), relating to the notice of adjustment of both the exercise price of and the number of warrant shares issuable under warrants issued to Empery in January 2017.2017 (the “Empery Suit”). The Empery Suit alleges that, as a result of certain circumstances in connection with ourthe Company’s February 2018 offering, the 166,672 warrants issued to Empery in January 2017 provide for adjustments to both the exercise price of the warrants and the number of warrant shares issuable upon such exercise. Empery seeks monetary damages and declaratory relief under theories of breach of contract or contract reformation predicated on mutual mistake. reformation.

While the Company believes that it has complied with the applicable protective features of the 2017 Warrants and properly adjusted the exercise price, if Empery were to prevail on all claims, the new adjusted total number of warrant shares could be as follows: 319,967 warrant shares for Empery Asset Master, Ltd., 159,869 warrant shares for Empery ITax Efficient, LP and 252,672 warrant shares for Empery Tax Efficient II, LP, and the exercise price could be reduced from $3.66$3.66 to $1.57$1.57 per share. On March 9, 2020, the Company filed a motion for summary judgment, which was denied by order of the NY Supreme Court entered on August 20, 2020, except for the second claim for relief for declaratory judgment which was dismissed as moot. On October 1, 2020, the Company filed a Notice of Appeal and appeal of the NY Supreme Court’s denial of summary judgment remains pending. Trial of this matter was conducted from April 19, 2021 to April 21, 2021, and a decision was reserved pending post-trial briefing of various issues, which was fully submitted by June 30, 2021.

While the Company hasasserted at trial and continues to asset several meritorious defenses against the claims, the ultimate resolution of the matter, if unfavorable, could result in a material loss. On March 9, 2020, we filed a motion for summary judgment, which remains pending.

 

On December 18, 2019,In addition to Empery, there are 1,139,220 2017 Warrants outstanding held by investors who did not participate in the Company terminatedFebruary 2018 financing transaction. Any further adjustments to the License Agreement with Circassia2017 Warrants pursuant to whichtheir antidilution provisions may result in additional dilution to the Company had granted Circassia an exclusive royalty-bearing license to distribute, market and sellinterests of the Company’s nitric oxide generatorstockholders and delivery system in the United States and China. As previously described in Note 9, Circassia had agreed to pay the Company certain milestone and royalty payments, with the remaining milestone and royalty payments payable in cash or ordinary shares of Circassia at Circassia’s option. The Company terminated the Agreement pursuant to section 13.3(b) of the Agreement, which provides for termination by either party upon the other party’s material breach or default. The Company is evaluating other options for the commercialization of its generator and delivery system. In connection the termination of the license with Circassia, we may be subject to a variety of claims. Adverse outcomes in some or all of these claims, if filed, may adversely affect ourthe market price of the Company’s common stock. The antidilution provisions may also limit the Company’s ability to conduct business and our financial condition and results of operations.obtain additional financing on terms favorable to it.

NOTE 14 SUBSEQUENT EVENTS

On August 6, 2020, the Company entered into a supply agreement expiring on December 31, 2024. The agreement will renew automatically for successive three year period(s) unless and until the Company provides twelve months’ notice of intent not to renew. In July 2020, the Company placed a non-cancellable purchase order for approximately $1,300,000 with this supplier.

2423

 

ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains “forward-looking statements.” Forward-lookingWe intend such forward-looking statements includeto be covered by the safe harbor provisions for forward-looking statements about our expectations, beliefs or intentionscontained in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, business strategy, prospective product offerings,candidates and products, product approvals, timing of our clinical development activities, research and development costs, timing and likelihood of success, and the plans and objectives of management for future operations and future results of anticipated products are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements express or implied by the forward-looking statements.

In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “expect,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential”, or “continue” or the negative of these terms or other similar conditional expressions. The forward-looking statements in this Quarterly Report are only predictions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition and results of operations, strategies or prospects. You can identify suchoperations. These forward-looking statements by the words “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” “likely,” “goal,” “assumes,” “targets” and similar expressions and/or the use of future tense or conditional constructions (such as “will,” “may,” “could,” “should” and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or resultsspeak only as of the date such statementsof this Quarterly Report on Form 10-Q and are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertaintiesa number of important factors that could cause our actual results to differ materially from any future results expressed or implied bythose in the forward-looking statements. Manystatements, including the factors could cause our actual activities or results to differ materiallydescribed under the sections in this Quarterly Report on Form 10-Q titled “Risk Factors” and results anticipated in forward-looking statements. These forward-looking statements are only predictions“Management’s Discussion and reflect our views asAnalysis of the date they are made with respect to future eventsFinancial Condition and financial performance. We undertake no obligation to update, and we do not have a policyResults of updating or revising, these forward-looking statements, except as required by applicable law. Please seeOperations,” Item 1A “Risk Factors” contained in our most recently filed Annual Report on Form 10-K, as well as the following:

our status as a development-stage company and our expectation to incur losses in the future;
our future capital needs and our need to raise additional funds;
our ability to obtain FDA approval of the PMA for the LungFit® system;
our ability to build a pipeline of product candidates and develop and commercialize products;
our ability to enroll patients in clinical trials, timely and successfully complete those trials and receive necessary regulatory approvals;
our ability to maintain our existing or future collaborations or licenses;
our ability to protect and enforce our intellectual property rights;
federal, state, and foreign regulatory requirements, including the FDA regulation of our product candidates;
our ability to obtain and retain key executives and attract and retain qualified personnel;
our ability to successfully manage our growth; and
our ability to address business disruption and related risks resulting from the COVID-19 pandemic, which could have a material adverse effect on our business plan.

Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for importantmanagement to predict all risk factors that could cause actual results to differ materially from those in the forward-looking statements.and uncertainties.

 

Management’s DiscussionYou should read this Quarterly Report on Form 10-Q and Analysisthe documents that we reference in this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results may be materially different from what we expect. We qualify all of Financial Condition and Resultsour forward-looking statements by these cautionary statements. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of Operationsany new information, future events, changed circumstances or otherwise.

 

Beyond Air, Inc. the Beyond Air logo, and other trademarks or service marks of Beyond Air, Inc. appearing in this Quarter Report on Form 10-Q are the property of Beyond Air, Inc. This Quarterly Report on Form 10-Q also includes trademarks, tradenames and service marks that are the property of other organizations. Solely for convenience, trademarks and tradenames referred to in this Quarterly Report on Form 10-Q appear without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or that the applicable owner will not assert its rights, to these trademarks and tradenames.

Introduction

We are an emerginga clinical-stage medical device and biopharmaceutical company developing a nitric oxide (“NO”) generator and delivery system (the “LungFit™ “LungFit®system”) that is capable of generating NO from ambient air. The LungFit™LungFit® platform can generate NO up to 400 parts per million (“ppm”) for delivery to a patient’s lungs. The LungFit™ lungs directly or via a ventilator. LungFit® can deliver NO either continuously or for a fixed amount of time at various flow rates and has the ability to either titrate dose on demand or maintain a constant dose. We believe that The LungFit™ LungFit®can be used to treat patients on ventilators that require NO, as well as patients with chronic or acute severe lung infections via delivery through a breathing mask or similar apparatus. Furthermore, we believe that there is a high unmet medical need for patients suffering from certain severe lung infections that the LungFit®LungFit® platform can potentially address. OurThe Company’s current areas of focus with the LungFit™ LungFit®are persistent pulmonary hypertension of the newborn (“PPHN”), severe acute respiratory syndrome coronavirus 2 (SARS CoV-2), bronchiolitis (“BRO”)PPHN, AVP including COVID-19, BRO and nontuberculous mycobacteria (“NTM”)NTM lung infection. OurThe Company’s current product candidates will be subject to premarket reviews and certifications or approvals by the U.S. Food and Drug Administration, or the FDA,(the “FDA”), as well as similar regulatory agencies in other countries or regions. If approved, ourthe Company’s system will be marketed as a medical device in the United States.

An additional focusprogram of the CompanyBeyond Air is solid tumors. For this indication the LungFit™ systemLungFit® platform is not utilized due to theneed for ultra-high concentrations of NO used.gaseous nitric oxide (“gNO”). We have developed a delivery system that can safely deliver NO concentrationsgNO in excess of 10,000 ppm directly to a solid tumor. This program is in pre-clinical development and will require approval from the FDA or similar agencyagencies in another country, approvalother countries to enter human studies. We expect to receive regulatory approval to enter a first in human trial by the end of calendar year 2021.

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The LungFit® system generates NO from ambient air by simulating the electric discharge caused from a lightning strike. Beyond Air proprietary technology allows for this reaction to occur in a plasma chamber. We believe the on-demand delivery, either to a ventilator circuit or directly to a patient’s lungs, is safe due to the Company’s system design and the Company’s proprietary nitrogen dioxide (“NO2”) filter. The NO2 filter removes toxic NO2 for 12 hours when used for PPHN and shorter periods for treating other conditions that require NO concentrations of 150 ppm or more.

With respect to PPHN, ourBeyond Air’s novel the LungFit® PH is designed to deliver a dosage of NO to the lungs that is consistent with current guidelines for delivery of 20 ppm NO with a range of 0.5 ppm – 80 ppm (low-concentration NO). for ventilated patients. We believe the LungFit™ hasability of LungFit® PH to generate NO from ambient air provides Beyond Air many competitive advantages over the current approvedstandard of NO delivery systems in the U.S., European Union, Japan and other markets. For example, the LungFit™LungFit® PH does not require the use of a high-pressure cylinder, does not require cumbersome purging procedures and places less burden on hospital staff in carrying out safety procedures.

OurThe Company’s novel LungFit™ systemLungFit® platform can also deliver a high concentration (>150 ppm) of NO directly to the lungs, which we believe has the potential to eliminate microbial infections including bacteria, fungi, and viruses, among other benefits.others. We believe current FDA-approved NO vasodilation treatments would have limited success in treating microbial infections given the low concentrations of NO being delivered.delivered (<100 ppm). Given that NO is produced naturally by the body as an innate immunity mechanism at a concentration of 200 ppm, supplemental high dose NO should aid in the body’s fight against infection. Based on ourthe Company’s pre-clinical and clinical studies, we believe that 150 ppm is the minimum therapeutic dose to achieve the desired pulmonary antimicrobial effect of NO. To date, neither the FDA nor equivalent regulatory agencies in other countries or regions have approved any NO formulation and/or delivery system for >80 ppm NO.

LungFit® PH for the deliverytreatment of Persistent Pulmonary Hypertension of the Newborn

In November 2020 we submitted a dosage of NO at 150 ppm or higherpremarket approval (“PMA”) application to the lungs.

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FDA for the use of LungFit® PH in PPHN. There is a standard 180-day review process that starts upon FDA acknowledgement of submission, though PMA reviews oftentimes take much longer, sometimes over a year or more. Moreover, the ongoing COVID-19 pandemic and an increased volume of submissions have led to longer review times by the FDA. We plan to submit for premarket approval or (“PMA”) to theanticipate an FDA response towards the end of thecalendar third calendar quarter of 2020 for the use of the LungFit™ in PPHN.2021. We also expect to make certain regulatory filings outsidereceive CE Mark under the MDR in the European Union around the end of the U.S. later in 2020.calendar year 2021. According to the 2019most recent year-end report from Mallinckrodt Pharmaceuticals, aggregate sales of low concentration NO were $574.1 million in 2020 (up from $571.4 million in 2019) for the United States, Canada, Japan, Mexico and Australia, with >90% in the U.S. were in excess of $500 million in 2019. Sales outsideUnited States. Outside of the U.S., where there are multiple market participants sales werewhich translates to considerably lower sales than in the U.S. We believe the U.S. sales potential of the LungFit™LungFit® PH in PPHN to be greater than $300 million and worldwide sales potential to be greater than $600 million. If regulatory approval is obtained, we anticipate a product launch in both the U.S. and Israel in the fourth quarter of calendar 2021 and will continue to launch in the EU and globally throughout 2021in 2022 and beyond.

SARS CoV-2LungFit® PRO for the treatment of viral lung infections in hospitalized patients

Acute Viral Pneumonia (including COVID-19)

Viral pneumonia in adults is a global pandemic with a widespread impact across many countries. Wemost commonly caused by rhinovirus, respiratory syncytial virus (“RSV”) and influenza virus. However, newly emerging viruses (including SARS-CoV-1, SARS-CoV-2, avian influenza A, and H1N1 viruses) have receivedbeen identified as pathogens contributing to the overall burden of adult viral pneumonia. COVID-19 is an approval from the FDA to run a study in COVID-19 (theinfectious disease caused by SARS CoV-2 infections) patients using ourSARS-CoV-2, that has resulted in a global pandemic. Excluding the LungFit™ system. We have also received approval from Health Canada to run a similar study to the one approved by the FDA. We look forward to results from both of these studiespandemic, there are approximately 350,000 annual viral pneumonia hospitalizations in the summer/fall of 2020. The fact that our system does not need cylinders allows us to potentially provide a practical solution to this crisis. We have applied for grants related to COVID-19 inUS, and 16 million annual viral pneumonia hospitalizations globally. For the United States and other countries. However, no external funding is required to perform the clinical studies recently approved by FDA and Health Canada.

With respect to bronchiolitis, we initiated in the fourth quarter of 2019 a double blind, controlled trial in infants hospitalized due to bronchiolitis with three arms and 89 subjects randomized 1:1:1 to standard supportive therapy (SST), SST plus 85 ppm NO and SST plus 150 ppm NO. The trial is complete and we recently released top line data. There were no SAE’s related to NO therapy. With respect to efficacy, the 150 ppm arm was statistically significant when compared to both the control arm and the 85 ppm arm on the primary endpoint of fit for discharge from the hospital and the key secondary endpoint of hospital length of stay. The 85 ppm was no different from control on both endpoints. We believe this is an exceptional result given the low number of patients and provides compelling evidence of the value of 150 ppm in achieving the desired efficacy. The pivotal study for bronchiolitis was originally set to be performed in the 2020/21 winter, but due to the SARS CoV-2 pandemic, hospitals will not be considering any new study proposals not related to SARS CoV-2 or COVID-19. We anticipate commencing a pivotal study in the United States in the fourth quarter of 2021 and completing it late in the second quarter of 2022, depending on the pandemic situation. We expect that we will submit a PMA to the FDA about 6 months after trial completion. Regulatory filings outside of the U.S. would begin after our review process is completed in the U.S. as long as no additional trials are required. For this indication,broader AVP, we believe U.S. sales potential to be greater than $500 million$1.5 billion and worldwide salesmarket potential to be greater than $1.2$3 billion.

 

Over 3We initiated a pilot study in late 2020 using Beyond Air’s novel LungFit® PRO system at 150 ppm to treat patients with acute viral pneumonia (AVP), including COVID-19. The ongoing trial is a multi-center, open-label, randomized clinical trial in Israel, including patients infected with SARS-CoV-2. Patients are randomized in a 1:1 ratio to receive either inhalations of 150 ppm NO given intermittently for 40 minutes four times per day for up to seven days in addition to standard supportive treatment (“NO+SST”) or standard supportive treatment alone (“SST”). Endpoints related to safety (primary endpoint), oxygen saturation, and ICU admission, among others, will be assessed.

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Beyond Air reported interim data from this ongoing trial at the American Thoracic Society or ATS International Conference 2021, which was held virtually from May 14 through May 19. At the time of the data cut off, the intent-to-treat (“ITT”) analysis population included 19 COVID-19 patients (9 NO + SST vs 10 SST). The data readout showed that 150 ppm NO treatment administered via LungFit® PRO was safe and well tolerated and demonstrated encouraging efficacy signals. From a safety perspective, there were no treatment-related, or possibly related, adverse events or severe adverse events. NO2 levels were below 4 ppm at all timepoints (trial safety threshold is 5 ppm) and methemoglobin (“MetHb”) levels were below 4% at all times (trial safety threshold is 10%). With respect to the requirement of oxygen support beyond hospital stay, 22.2% of subjects in the NO + SST group compared with 40% of control subjects had this requirement. There was an observable trend of shortening the duration of hospital stay and duration on oxygen support for treated patients. Additional detailed study results may be submitted for presentation at an upcoming scientific meeting.

Bronchiolitis (BRO)

Bronchiolitis is the leading cause of hospital admission in children less than 1 year of age. The incidence is estimated to be 150 million new cases a year worldwide, with 2-3% (over 3 million) of bronchiolitis are reported worldwide each year.them severe enough to require hospitalization. Worldwide, 95%3 of all cases occur in developing countries. In the U.S., there are approximately 130,000more than 120,000 annual bronchiolitis hospitalizations among children two years of age or younger and approximately 177,0003.2 million annual child hospitalizations among the elderly population related to RSV infection only with the number rising higher due to other viruses similar to those that cause bronchiolitis in very young children.

globally. Currently, there is no approved treatment for bronchiolitis. The treatment for acute viral lung infections that cause bronchiolitis in infants is largely supportive care and is based primarily on prolonged hospitalization during which the infant receives a constant flow of oxygen to treat hypoxemia, a reduced concentration of oxygen in the blood. In addition, systemic steroids and inhalation with bronchodilators are sometimes utilized until recovery, but we believe that these treatments do not successfully reduce hospital length of stay.

Our NTM program has produced data from four compassionate use subjects We believe the U.S. market potential for bronchiolitis to be greater than $500 million and nine patients from a multi-center pilot study completed in 2018. All patients suffered from NTM abscessus infection and had underlying cystic fibrosis. One compassion patient was treated with our nitric oxide generator at the National Heart, Lung and Blood Institute (“NHLBI”). All others were treated with our NO cylinder-based delivery system. All patients were treated with 160 ppm NO at intermittent 30-minute dosing over 21 days, except one patient who was treated over 26 days and another patient who was treated with 250 ppm NO over 28 days. We expected to begin a study by the end of 2020 (delayed about 6 months by the COVID-19 pandemic) where patients would self-administer high concentration NO at home over a period of 12 weeks with the LungFit™ We now anticipate preliminary data for this study will be available during the first half of 2021 and that a full dataset will be available in the second half of 2021. If the trial is successful, we would commence a pivotal study in 2022. For this indication, we believe U.S. salesworldwide market potential to be greater than $1 billion and worldwide sales potential$1.2 billion.

The Company’s BRO program is currently on hold due to the COVID-19 pandemic. The pivotal study for bronchiolitis was originally set to be greater than $2.5 billion.performed in the winter of 2020/21 but was delayed due to the pandemic. We have completed three successful pilot studies for bronchiolitis. A further analysis of the three previously reported pilot studies was presented at the ATS International Conference 2021, which was held virtually from May 14 – May 19. Analysis across the studies (n=198 infants, mean age 3.9 months) showed that 150 – 160 ppm NO administered intermittently was generally safe and well tolerated with adverse event rates similar among treatment groups with no reported treatment-related serious adverse events. The short course of treatments with intermittent high concentration inhaled NO was effective in shortening hospital length of stay and accelerating time to fit for discharge – a composite endpoint of clinical signs and symptoms to indicate readiness to be evaluated for hospital discharge. This treatment was also effective in accelerating time to stable oxygen saturation – measured as SpO2 ≥ 92% in room air. Additionally, NO at a dose of 85 ppm NO showed no difference compared to control for all efficacy endpoints, while 150 ppm NO showed statistical significance when compared to control.

We believe that the entirety of data at 150-160 ppm NO in both adult and infant patient populations supports further development of LungFit® PRO in a pivotal study for patients hospitalized with viral pneumonia.

LungFit® GO for the treatment of Nontuberculous mycobacteria (NTM)

NTM lung infection is a rare and serious pulmonary disease associated with increased morbidity and mortality. There is an increasing rate of lung disease caused by NTM, which is an emerging public health concern worldwide. There are approximately 50,000 patients diagnosed with NTM in the U.S., and there are an estimated additional 100,000 patients in the U.S. that have not yet been diagnosed. In Asia, the number of patients suffering from NTM surpasses what is seen in the U.S. To date we have treated only the abscessus form of NTM which comprises approximately 20-25% of all NTM. We will be treating both the abscessus and mycobacterium avium complex (MAC) forms of NTM.

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Patients with NTM lung disease may experience a multitude of symptoms such as fever, weight loss, cough, lack of appetite, night sweats, blood in the sputum and fatigue. Patients with NTM lung disease, specifically Mycobacterium abscessus(M.abscessus) representing 20-25% of all NTM and other forms of NTM that are refractory to antibiotic therapy,frequently require lengthy and repeated hospital stays to manage their condition. There are no treatments specifically indicated for the treatment of NTM M. abscessus lung disease in North America, Europe or Japan.

There are approximately 50,000 to 90,000 people with NTM infections in the U.S. In Asia, the number of patients suffering from NTM surpasses what is seen in the U.S. There is one inhaled antibiotic approved in the U.S. for the treatment of refractory NTM MAC.Mycobacterium avium complex (“MAC”). Current guideline-based approaches to treat NTM lung disease involve multi-drug regimens of anti-bioticsantibiotics that may cause severe, long lasting side effects, and treatment can be as long as 18 months or more. Median survival for NTM MAC patients is approximately 13 years while median survival for patients with other variations of NTM is typically 4.6 years. The prevalence of human disease attributable to NTM has increased over the past two decades. In a study conducted between 19972007 and 2007,2016, researchers found that the prevalence of NTM in the U.S. is increasing at approximately 8%7.5% per year and that NTM patients on Medicare over the age of 65 are 40% more likely to die over the period of the study than those who did not have the disease (Adjemian et al., 2012). NTM year. M. abscessus treatment costs are estimated to be more than double that of NTM MAC. In total, a 2015 publication from co-authors from several U.S. government departments stated that prior year statistics led to a projected 181,037 national annual cases in 2014 costingcost the U.S. healthcare system approximately $1.7 billion. For this indication, we believe U.S. sales potential to be greater than $1 billion (Strollo et al., 2015).and worldwide sales potential to be greater than $2.5 billion.

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For our solid tumor program,In December 2020 we released pre-clinical databegan a 12-week, multi-center, open-label clinical trial in Australia and we plan to enroll approximately 20 adult patients with chronic refractory NTM lung disease. We received a grant of up to $2.17 million from the Cystic Fibrosis Foundation to fund this study and advance the clinical development of inhaled NO to treat NTM pulmonary disease. The trial is enrolling both cystic fibrosis (“CF”) and non-CF patients infected with MAC or M. abscessus. The study consists of a run-in period followed by two treatment phases. The run-in period provides a baseline for the efficacy endpoints. The first treatment phase takes place over a two-week period and begins in the hospital setting where patients will be titrated from 150 ppm NO up to 250 ppm NO over several days. During this phase patients receive NO for 40 minutes, four times per day while MetHb levels are monitored. Patients are also trained to use LungFit® GO and subsequently discharged to complete the remaining portion of the two-week treatment period at their home at the virtual American Academyhighest tolerated NO concentration. For the second treatment phase, a 10-week maintenance phase, the administration is twice daily. The study is evaluating safety, quality of Cancer Research (AACR) showing the promise of delivering NO at concentrations of 25,000 ppm – 200,000 ppm directly to tumors. Results showed local tumor ablation with complete eradication in 5 of 30 mice. Additionally, regardless of whether the tumor was completely or partially cleared, all colon tumor bearing mice were resistant to a second challenge of colon cancer. Breast tumor bearing mice showed a 7-10 day delaylife, physical function, and bacterial load among other parameters.

We anticipate reporting interim data in the uptakefall of breast cancer post challenge. Pre-clinical workcalendar year 2021, likely at a scientific conference. We will continue throughoutrelease top-line results for the restfull data set approximately six months later. If the trial is successful, we would anticipate commencing a pivotal study in the first half of 2020 and most of 2021.calendar year 2023.

OurThe Company’s program in chronic obstructive pulmonary disease (“COPD”) is in the pre-clinical stage and will remain there, subject to our obtaining additional financing.

Ultra-High Concentration NO in solid tumors

For the Company’s solid tumor program, we have released pre-clinical data at several medical/scientific conferences showing the promise of delivering NO at concentrations of 20,000 ppm – 200,000 ppm directly to tumors. Results showed that local tumor ablation with NO conveyed anti-tumor immunity to the host. In the Company’s most recent release of data, 8 of 11 mice treated with a single administration of 25,000 ppm NO over 5 minutes were resistant to a subsequent tumor challenge and 11 of 11 mice treated with 50,000 ppm NO were resistant to a subsequent tumor challenge. Pre-clinical work will continue throughout most of 2021 with a goal of receiving regulatory approval to initiate a first-in-human trial by the end of calendar year 2021.

COVID-19

The development of ourthe Company’s product candidates could be further disrupted and adversely affected by a resurgence of the recent outbreak of COVID-19.COVID-19 pandemic. The spread of SARS CoV-2 from China to other countries has resultedCompany experienced significant delays in the Director General ofsupply chain for LungFit® due to the World Health Organization declaring COVID-19 a pandemic on March 11, 2020. We have addressedredundancy in parts and suppliers with ventilator manufacturing which has since been remedied. The Company continuously assesses the impact COVID-19 may have on ourthe Company’s business plans and ourits ability to conduct the preclinical studies and clinical trials as well as on ourthe Company’s reliance on third-party manufacturing and ourBeyond Air’s supply chain. However, there can be no assurance that this analysisthe Company will enable usbe able to avoid part or all of any impact from the spread of COVID-19 or its consequences. The extentconsequences if a resurgence occurs.

Critical Accounting Estimates and Policies

A critical accounting policy is one that is both important to which the COVID-19 pandemicportrayal of a company’s financial condition and global efforts to contain its spread will impact ourresults of operations will depend on future developments, which are still uncertain and cannot be predicted at this time. Asrequires management’s most difficult, subjective or complex judgments, often as a consequenceresult of the global pandemic, Beyond Air experienced significant delays inneed to make estimates about the supply chain for LungFit™ due to the redundancy in parts and suppliers with ventilator manufacturing. Our bronchiolitis program will experience at least a one year delay and our PPHN and NTM programseffect of matters that are estimated to experience a delay of 4-6 months.inherently uncertain.

Critical Accounting Policies

The accounting policies followed in the preparation of our condensedCompany’s unaudited consolidated financial statements appearing atare presented in accordance with U.S. GAAP, and all applicable U.S. GAAP accounting standards effective as of June 30, 2021 have been taken into consideration in preparing the beginningunaudited consolidated financial statements. The preparation of this Quarterly Report on Form 10-Q are consistent in all material respects with those included in Note 2 of our Annual Report on the Form 10-K for the year ended March 31, 2020. The unaudited condensed consolidated financial statements requires estimates and assumptions that affect the reported amounts of assets, liabilities, expenses and related disclosures. Some of those estimates are subjective and complex, and, consequently, actual results could differ from those estimates. The following accounting policies and estimates have been preparedhighlighted as significant because changes to certain judgments and assumptions inherent in accordance with generally accepted accounting principles inthese policies could affect the United States (“US GAAP”) for interim financial information and with the instructions to Form 10-Q. Accordingly, they do not include all of the information and footnotes required to be presented for complete financial statements. The accompanying condensedCompany’s consolidated financial statements reflect all adjustments (consisting only of normal recurring items) which are, in the opinion of management, necessary for a fair presentation of the results for the interim periods presented. The accompanying condensed consolidated Balance Sheet as of March 31, 2020 has been derived from the audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended March 31, 2020. The condensed consolidated financial statements and related disclosures have been prepared with the assumption that users of the interim financial information have read or have access to the audited consolidated financial statements for the preceding fiscal year. Accordingly, these financial statements should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in the Annual Report on Form 10-K for the year ended March 31, 2020 which was filed with the United States Securities and Exchange Commission, (“SEC”), on June 23, 2020.statements:

Use of Estimates,
Research and development expenses,
Stock-based compensation expenses, and
Income Taxes

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Off-Balance SheetOff-Balance-Sheet Arrangements

As of June 30, 2020,2021, we did not have any off-balance sheetoff-balance-sheet arrangements as defined in the rules and regulations of the Securities and Exchange Commission.Commission the (“SEC”).

Results of Operations

Below are the results of operations for the three months ended June 30, 20202021 and June 30, 2019:2020:

 

  

For the Three
Months Ended

June 30,

 
  2021  2020 
       
License revenue $-  $229,161 
         
Operating expenses        
Research and development  2,741,041   4,331,814 
General and administrative  3,850,265   2,494,014 
         
Operating loss  (6,591,306)  (6,596,667)
         
Other income (loss)        
Dividend income  706   14,985 
Foreign exchange gain  9,859   1,275 
Interest expense  (162,143)  (163,240)
Other  -   1,843 
Total other loss  (151,578)  (145,137)
         
Net loss $(6,742,884) $(6,741,804)
         
Net loss per share – basic and diluted $(0.31) $(0.41)
         
Weighted average number of common shares outstanding – basic and diluted  21,945,235   16,529,392 

  

For the Three Months Ended

June 30,

 
  2020  2019 
       
License revenues $229,161  $627,469 
         
Operating expenses        
Research and development  4,331,814   2,323,513 
General and administrative  2,494,014   2,182,558 
         
Operating loss  (6,596,667)  (3,878,602)
         
Other income (loss)        
Realized and unrealized loss on marketable equity securities  -   (2,307,319)
Dividend income  14,985   6,410 
Foreign exchange gain  1,275   1,724 
Interest expense  (163,240)  (3,034)
Other  1,843   - 
Total other loss  (145,137)  (2,302,219)
         
Net loss $(6,741,804) $(6,180,821)
         
Net loss per share – basic and diluted $(0.40) $(0.67)
         
Weighted average number of common shares outstanding – basic and diluted  16,529,392   9,201,855 

Comparison of Three Months Ended June 30, 20202021 with the Three Months Ended June 30, 20192020

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License revenue for the three months ended June 30, 2020 was $229,161 as compared to $627,469 for the three months ended June 30, 2019. Revenue

On January 23, 2019, the Company entered into an agreement for commercial rights (the “License“Circassia Agreement”) with Circassia Limited and its affiliates (collectively, “Circassia”) for persistent pulmonary hypertension of the newborn (“PPHN”)PPHN and future related indications at concentrations of <80 ppm in the hospital setting in the United States and China. During the year ended March 31, 2019, the Company met the first two milestones under the license agreement and received 17,572,815 ordinary shares valued at $9,987,295. This consideration was allocated to the first two performance obligations. one being the transfer of the intellectual property to Circassia, which was recognized at a point in time and was valued at $7,116,232 and the other being the ongoing support associated with the PMA submission and regulatory approval by the FDA, which was valued at $2,871,063 and recorded as deferred revenue to be recognized over a period of time from the commencement of the agreement to when management expects to submit the PMA. For the three months ended June 30, 2020, and June 30, 2019, $229,161 and $627,469, respectively of such revenue associated with this second performance obligation has been recognized. As of June 30, 2020, and March 31, 2020, deferred revenue was $644,029 and $1,635,825, respectively. On December 18, 2019, the Company terminated the License Agreement with Circassia pursuantAgreement. Prior to whichthe three month period ending June 30, 2021, the Company has met its performance obligation under the Circassia Agreement and all the revenue had granted Circassia an exclusive royalty-bearing license to distribute, marketbeen previously recognized. License revenue of $0 and sell$229,161 associated with the Company’s nitric oxide generatorsecond performance obligation has been recognized for the three months ended June 30, 2021 and delivery system in the United States and China.June 30, 2020, respectively.

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Research and development expensesDevelopment Expenses

Research and development expenses for the three months ended June 30, 2020 was $4,331,8132021 were $2,741,041 as compared to $2,323,513$4,331,814 for the three months ended June 30, 2019.2020. The increasedecrease of $2,008,300$1,590,773 was primarily attributed to developmentless expenses for PPHN due to the submission of the LungFit™ System for PPHN, clinical trial for COVID-19, completionPMA in November 2020 and a decrease in non-cash compensation expense of the Bronchiolitis trial, an increase in salaries and employee benefits and an increase in stock-based compensation expense.$472,898.

General and administrative expensesAdministrative Expenses

General and administrative expenseexpenses for the three months ended June 30, 2020, was $2,494,014 as compared to the three months2021 and June 30, 2019 of $2,182,558.2020 were $3,850,265 and $2,494,014, respectively. The increase of $311,456$1,356,251 was attributed primarily attributed to anchanging legal counsel, increase stock-based compensation expense of $209,090.

Other income (loss)

Other lossin professional fees, preparation for the three months ended June 30, 2020 was $145,137 as compared $2,302,219 for the three months ended June 30, 2019. For the three months ended June 30, 2020, the Company incurred interest expense including amortization of debt discountcommercial launch, increase in salaries and deferred financing expense of approximately $164,000. Other loss for the three months ended June 30, 2019 was primarily from the realizedbenefits and unrealized loss of Circassia Pharmaceuticals plc stock of $2,307,319. insurance.

Cash Flows

Below is a summary of the Company’s cash flows activities for the three months ended June 30, 20202021 and forJune 30, 2020:

  Three Months Ended 
  June 30, 
  2021  2020 
       
Net cash provided by (used in):        
Operating activities $(3,918,178) $(5,485,465)
Investing activities  (27,055)  (243,527)
Financing activities  8,305,518   4,709,098 
Net increase (decrease) in cash, cash equivalents and restricted cash $4,360,285  $(1,019,894)

Operating Activities

For the three months ended June 30, 2019:

  Three Months Ended 
  June 30, 
  2020  2019 
       
Net cash provided by (used in):        
Operating activities $(5,485,465) $(2,909,911)
Investing activities  (243,527)  (6,775,002)
Financing activities  4,709,098   8,980,796 
Net decrease in cash, cash equivalents and restricted cash $(1,019,894) $(704,117)

Operating Activities

2021 the net cash used in operating activities was $3,918,178 which was primarily due to the Company’s net loss of $6,742,884, offset by non-cash stock-based compensation expense of $1,215,911, cash provided from a grant receivable of $425,000, a decrease in prepaid expenses of $205,032 and an increase of $946,648 of accounts payable. For the three months ended June 30, 2020 the net cash used in operating activities was 5,484,465$5,484,465 which was primarily due to ourthe Company’s net loss of $6,741,804 and a usedecrease of cash for other current assets,$335,893 from accounts payable and accrued expense of $406,234. Therepayable. In addition, there was non-cash stock-based compensation expense of $1,815,654 and non-cash decrease foramortization of deferred revenue. revenue of $229,161.

Investing Activities

For the three months ended June 30, 2019 net cash used in operating activities $2,909,991 which was primarily due to the net loss of $6,180,8212021 and there was a non-cash decrease for deferred revenue of $627,469. Source of cash was from other current assets and accounts payable of $631,588. There were non-cash stock-based compensation expense of $941,537 and realized and unrealized loss on marketable securities of $2,307,319.

Investing Activities

For the three months ended June 30, 2020, net cashed used in investing activities was $243,537$27,055 and this$243,527, respectively, which was for the purchase of property and equipment. For

Financing Activities

Net cash provided by financing activities for the three months ended June 30, 20192021 was $8,305,518 and which was primarily from the net cash used in investing activities was $6,775,002.

Financing Activities

proceeds for the issuance of common stock related to the Stock Purchase Agreement and ATM of $8,512,867 offset by a loan payment of $207,349. Net cash provided by financing activities for the three months ended June 30, 2020 was $4,709,098 andwhich was primarily from the net proceeds forfrom the issuance of common stock issued related to the Stock Purchase Agreement with LPC, net proceeds the issuance of common stock in connection with At the Market offering,ATM and proceeds from the issuance of common stock from warrant exercises. Net cash providedexercises of $4,834,877 offset by financing activitiesa loan payment of $125,779.

Contractual Obligations

There have been no material changes to our contractual obligations since March 31, 2021. For a summary of our contractual obligations, see Item 7 of Part II of our Annual Report on Form 10-K for the three monthsyear ended March 31, 2021 (the “2021 Annual Report”), filed with the SEC on June 30, 2019 was $8,980,79610, 2021 and was primarily from the net proceeds of a private placement of $7,839,495, and the issuance and sale of $1,173,810 of common stock to LPC.amended on July 23, 2021.

 

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Liquidity and Capital Resources

Overview

We have incurred losses and generated negative cash flows from operations since inception. To date, we have not generated any revenue from the sale of products, and we do not expect to generate revenue from sale of our products until certification or regulatory approval is received for our product candidates. Since the time the Company became public through June 30, 2020, we have funded our operations principally through the issuance of equity securities and debt. As shown in the accompanying financial statements, the Company hasWe had an operating cash flow decrease of $5.5$3.9 million for the three months ended June 30, 20202021 and we have experienced an accumulated lossesloss of $64.2 million since inception through June 30, 2020. The Company has cash, cash equivalent and restricted cash of $24.4$87.2 million as of June 30, 2020.2021. As of June 30, 2021, we had cash, cash equivalents and restricted cash of $39.6 million. We believe that our cash, cash equivalents of June 30, 2021, will enable us to fund our operating expenses and capital expenditure for at least one year from the date of filing these financial statements.

Our future capital needs and the adequacy of its available funds will depend on many factors, including, but not necessarily limited to, the cost and time necessary for the development, clinical studies and certification or regulatory approval of our other medical devices, indications as well as the commercial success of our first product candidates that receive marketing approval by the FDA. The Company may be required to raise additional funds through equity or debt securities offerings or strategic collaboration and/or licensing agreements in order to fund operations until it is able to generate enough product or royalty revenues, if any. Such financing may not be available on acceptable terms, or at all, and the Company’s failure to raise capital when needed could have a material adverse effect its strategic objectives, results of operations and financial condition.

There can be no assurance that we will be able to obtain additional equity or debt financing on terms acceptable to us, if at all.

On March 17, 2020, the Companywe entered into a facility agreement (the “Facility Agreement”) with certain lenders (“Facility Agreement”) pursuant to which the lenders shallagreed to loan to up to $25,000,000 in five tranches of $5,000,000 per tranche at theour option, of the Company (“Tranches”), provided however that the Companywe may only utilize tranches three through five following FDA approval of the LungFit™ PH product.LungFit® PH. The loan(s) are unsecured with an interest rate of 10% per annum which is paid quarterly and may be prepaid with certain prepayment penalties. The effective interest rate for this loan is 13.3% per year. Each tranche shallmust be repaid in installments commencing June 15, 2023 with all remaining amounts outstanding under any tranche due on March 17, 2025. We drew down on the first tranche of $5,000,000.

On April 2, 2020, Beyond Air, Inc.we entered into an At-The-Market Equity Offering for $50 millionSales Agreement with SunTrust Robinson Humphrey, Inc. and utilizedOppenheimer & Co. (the “ATM”). Under the Company’s shelf registration statement. The CompanyATM, we may sell shares of our common stock having aggregate sales proceeds of up to $50,000,000$50 million, from time to time in this offering.and at various prices. If shares of our common stock are sold, there is a three 3 percent fee paid to the sales agent. As of June 30, 2021, there was a balance of approximately $29.9 million available under the ATM.

On May 14, 2020, the Companywe entered into athe $40 million NewStock Purchase Agreement with LPC, that(with Lincoln Park Capital Fund, LLC (“LPC”), which replaced the existingformer $20 million purchase agreement.agreement with LPC, dated August 10, 2018. The NewStock Purchase Agreement provides for the issuance of up to $40 million of the Company’sour common stock, which we may sell from time to time in our sole discretion, to Lincoln ParkLPC over the next 36 months, subject to the conditions and limitations in the New Stock Purchase Agreement. As of June 30, 2021, there was a balance of approximately $28.2 million available under the New Stock Purchase Agreement.

Our ability to continue to operate isbeyond twelve months from the filing of this Form 10-K will be largely dependent upon the filingapproval of our PMA for the PPHN medical device, the expected timing and commercial acceptance of the Company’s launch of our product,this device, as well as obtaining Partnerspartners in other parts of the world, timing of future milestones and royalties, raising additional funds to finance our activities. Thereactivities until we are generating cash flow from operations. Further, there are no assurances that we will be successful in obtaining an adequate level of financing for the development and commercialization of our other product candidates. The Company’s ability to continue to operate is dependent upon raising additional funds to finance its activities.

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There are numerous risks and uncertainties associated with the development of our NO delivery system and we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the research and development of our product candidate.candidates.

Our future capital requirements will depend on many factors, including:

the effects of the COVID-19 pandemic on our business, the medical community and the global economy;
the progress and costs of our preclinical studies, clinical trials and other research and development activities;
the costs of commercializing the LungFit® system, if approved;
the scope, prioritization and number of our clinical trials and other research and development programs;
the costs and timing of obtaining certification or regulatory approval for our product candidates;
the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;
the costs of, and timing for, strengthening our manufacturing agreements for production of sufficient clinical quantities of our product candidate;
the potential costs of contracting with third parties to provide marketing and distribution services for us or for building such capacities internally;
the costs of acquiring or undertaking the development and commercialization efforts for additional, future therapeutic applications of our product candidate;candidates;
the magnitude of our general and administrative expenses; and
any cost that we may incur under current and future in-and out-licensing arrangements relating to our product candidate.candidates.

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ITEM 3. Quantitative and Qualitative Disclosures About Market Risk

We are exposed to market risks in the ordinary course of our business. Market risk represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates. Our market risk exposure is primarily a result of foreign currency exchange rates.

ITEM 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer (our principal executive officerofficer) and Chief Financial Officer (our principal financial officer,officer), of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the Exchange Act).Act. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based upon our evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures arewere effective at the reasonable assurance level as of June 30, 2020, in ensuring that material information that we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission rules and forms.2021.

Changes in Internal Control Over Financial Reporting

During the three months ended June 30, 2020,2021, there was no change in our internal controlcontrols over financial reporting that materially affected, or is reasonablereasonably likely to materially affect our, internal controlcontrols over financial reporting.

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PART II OTHER INFORMATION

Item 1. Legal Proceedings

See Note 1314 to our unaudited condensed consolidated financial statements.

ITEM 1A. RISK FACTORS

There have been no material changes with respect to risk factors previously disclosed in the Company’s Form 10-K for the year ended March 31, 2021, filed with the Securities and Exchange Commission on June 10, 2021.

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

None.

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

None.

ITEM 4. MINE SAFETY DISCLOSURE

Not Applicable.

ITEM 5. OTHER INFORMATION

Not Applicable.

ITEM 6. Exhibits.

Exhibit No. Description
   
31.13.1 

Amended and Restated Certificate of Incorporation of AIT Therapeutics, Inc., dated January 9, 2017, filed as Exhibit 3.1 to our Current Report on Form 8-K, as amended and filed with the SEC on March 15, 2017, and incorporated herein by reference.

3.2Certificate of Amendment of the Amended and Restated Certificate of Incorporation, dated June 25, 2019, filed as Exhibit 3.3 to our Annual Report on Form 10-K, as filed with the SEC on June 28, 2019, and incorporated herein by reference.
3.3Form of Second Certificate of Amendment of the Amended and Restated Certificate of Incorporation of Beyond Air, Inc. (included in Appendix C to our Definitive Proxy Statement, filed with the SEC on January 22, 2021 and incorporated herein by reference).
3.4Amended and Restated Bylaws of AIT Therapeutics, Inc., filed as Exhibit 3.2 to our Current Report on Form 8-K, as amended and filed with the SEC on March 15, 2017, and incorporated herein by reference.
4.1Form of Common Stock Certificate, filed as Exhibit 4.1 to our Current Report on Form 8-K, as amended and filed with the SEC on March 15, 2017, and incorporated herein by reference.
4.2Form of Warrant to Purchase Common Stock, by and among AIT Therapeutics, Inc. and the Holders party thereto, filed as Exhibit 10.3 to our Current Report on Form 8-K, as amended and filed with the SEC on March 15, 2017, and incorporated herein by reference.
4.3Form of Warrant to Purchase Common Stock, by and among AIT Therapeutics, Inc. and the Holders party thereto, filed as Exhibit 4.1 to our Current Report on Form 8-K, as filed with the SEC on April 4, 2017, and incorporated herein by reference.
4.4Form of Warrant to Purchase Common Stock, by and among AIT Therapeutics, Inc. and the Holders party thereto, filed as Exhibit 4.1 to our Current Report on Form 8-K, as filed with the SEC on February 22, 2018, and incorporated herein by reference.
4.5Form of Warrant to Purchase Common Stock, filed as Exhibit 4.1 to our Current Report on Form 8-K, as filed with the SEC on March 20, 2020 and incorporated herein by reference.
10.1*#Settlement Agreement and Release, dated May 26, 2021, by and between Beyond Air, Inc. and Circassia Limited.
10.2*

Executive Employment Agreement, dated June 30, 2018, by and between AIT Therapeutics, Inc. and Steven Lisi.

10.3*Executive Employment Agreement, dated June 30, 2018, by and between AIT Therapeutics, Inc. and Amir Avniel.
31.1Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 20022002.
   
31.2 Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 20022002.
   
32.1 Certification of Chief Executive Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
   
32.2 

Certification of Chief Financial Officer pursuant to 18 U.S.C Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 20022002.

   
101.INS Inline XBRL Instance Document – The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the XBRL document.
   
101.SCH Inline XBRL Taxonomy Extension Schema Document
   
101.CAL Inline XBRL Taxonomy Extension Calculation Linkbase Document
   
101.DEF Inline XBRL Taxonomy Extension Definition Linkbase Document
   
101.LAB Inline XBRL Taxonomy Extension Label Linkbase Document
   
101.PRE Inline XBRL Taxonomy Extension Presentation Linkbase Document
104Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
Filed herewith
Pursuant to Item 601(b)(10) of Regulation S-K, portions of this exhibit have been omitted as the registrant customarily and actually treats the omitted information as private or confidential and the omitted information is not material.

**** Confidential treatment has been requested for portions of this exhibit

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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.

BEYOND AIR, INC.
/s/ Steven Lisi
Date: August 6, 202010, 2021Steven Lisi
President and Chief Executive Officer
(Principal Executive Officer)
/s/ Douglas Beck
Date: August 6, 202010, 2021Douglas Beck
Chief Financial Officer
(Principal Financial and Accounting Officer)

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