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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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

 

For the quarterly period ended December 31, 2023

 

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, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   47-3812456

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

     
900 Stewart Avenue, Suite 301    
Garden City, NY   11530
(Address of principal executive offices)   (Zip Code)

 

516-665-8200

(Registrant’s telephone number, including area code)

 

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

 

Title of each class:   Trading Symbol   Name of each exchange on which registered:
Common Stock, par value $0.0001 per share   XAIR   The 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 ☒ 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 ☒ 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 Smaller reporting company
    Emerging growth company

 

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

 

As of February 12, 2024, there were 36,039,056 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 DECEMBER 31, 2023

 

Table of Contents

 

  Page
   
PART I FINANCIAL INFORMATION 3
   
ITEM 1. Condensed Consolidated Financial Statements (Unaudited) 3
   
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 25
   
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk 35
   
ITEM 4. Controls and Procedures 35
   
PART II OTHER INFORMATION 36
   
ITEM 1. Legal Proceedings 36
   
ITEM 1A. Risk Factors 36
   
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds 36
   
ITEM 3. Defaults Upon Senior Securities 36
   
ITEM 4. Mine Safety Disclosures 36
   
ITEM 5. Other Information 36
   
ITEM 6. Exhibits 37
   
SIGNATURES 38

 

2

 

 

PART I FINANCIAL INFORMATION

 

ITEM 1. Financial Statements.

 

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

INDEX

 

  Page
   
Condensed Consolidated Balance Sheets 4
   
Condensed Consolidated Statements of Operations and Comprehensive Loss 5
   
Condensed Consolidated Statements of Changes in Stockholders’ Equity 6
   
Condensed Consolidated Statements of Cash Flows 8
   
Notes to Condensed Consolidated Financial Statements 9– 24

 

3

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(amounts in thousands, except share and per share data)

 

   December 31,
2023
   March 31,
2023
 
   (Unaudited)     
ASSETS          
Current assets          
Cash and cash equivalents  $7,971   $29,158 
Marketable securities   23,292    16,724 
Restricted cash   231    7,610 
Accounts receivable   294    - 
Inventory, net   1,533    1,129 
Grant receivable   -    420 
Other current assets and prepaid expenses   6,118    4,369 
Total current assets   39,439    59,410 
Licensed right to use technology   1,478    1,632 
Right-of-use lease assets   2,229    2,493 
Property and equipment, net   8,551    5,003 
Other assets   213    212 
TOTAL ASSETS  $51,911   $68,749 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current liabilities          
Accounts payable  $3,220   $2,016 
Accrued expenses   7,882    16,613 
Operating lease liability, current portion   408    376 
Loans payable, current portion   130    775 
Total current liabilities   11,641    19,780 
           
Operating lease liability, net   2,012    2,321 
Long-term debt   14,380    120 
Warrant liability   192    - 
Derivative liability   214    - 
Other long-term liabilities   -    4,500 
Total liabilities   28,440    26,721 
           
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, 35,478,123 and 30,738,585 shares issued and outstanding as of December 31, 2023 and March 31, 2023, respectively   4    3 
Treasury stock   (25)   (25)
Additional paid-in capital   246,792    217,339 
Accumulated deficit   (225,990)   (179,455)
Accumulated other comprehensive income   34   53 
Total stockholders’ equity attributable to Beyond Air, Inc   20,814    37,915 
Non-controlling interest   2,657    4,113 
Total equity   23,471    42,028 
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY  $51,911   $68,749 

 

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

 

4

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(amounts in thousands, except share and per share data)

(UNAUDITED)

 

   2023   2022   2023   2022 
   For the Three Months Ended   For the Nine Months Ended 
   December 31,   December 31, 
   2023   2022   2023   2022 
                 
Revenue  $391   $-   $689   $- 
                     
Cost of revenue   748    68    1,483    247 
                     
Gross loss   (356)   (68)   (794)   (247)
                     
Operating expenses:                    
                     
Research and development   (6,838)   (5,000)   (18,664)   (12,679)
General and administrative   (9,768)   (8,941)   (30,915)   (25,144)
Operating expenses   (16,606)   (13,941)   (49,578)   (37,823)
                     
Operating loss   (16,963)   (14,010)   (50,372)   (38,070)
                     
Other income (expense)                    
Dividend/interest income and gains on marketable securities   388    271    1,438    388 
Interest expense   (919)   (46)   (1,991)   (142)
Change in fair value of warrant liability   46    -    693    - 
Change in fair value of derivative liability   135    -    1,147    - 
Foreign exchange gain and loss   31    286    (3)   (108)
Estimated liability for contingent loss   (11)   (248)   (609)   (248)
Other income/ (expense)   35    (52)   (42)   (71)
Total other income (expense)   (294)   211   633    (180)
                     
Benefit from income taxes   -    -    -    - 
                     
Net loss  $(17,258)  $(13,798)  $(49,739)  $(38,250)
                     
Less : net loss attributable to non-controlling interest   (1,038)   (1,051)   (3,204)   (2,601)
                     
Net loss attributable to Beyond Air, Inc.   (16,220)   (12,747)   (46,535)   (35,649)
                     
Foreign currency translation gain /(loss)   (9)   (184)   (19)   159 
Comprehensive loss attributable to Beyond Air, Inc.  $(16,229)  $(12,931)  $(46,554)  $(35,490)
                     
Net basic and diluted loss per share attributable to Beyond Air, Inc.  $(0.50)  $(0.43)  $(1.46)  $(1.19)
                     
Weighted average number of shares, outstanding, basic and diluted   32,462,476    29,921,254    31,883,799    29,902,694 

 

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 STOCKHOLDERS’ EQUITY

(UNAUDITED)

FOR THE THREE AND NINE MONTHS ENDED DECEMBER 31, 2023

(amounts in thousands, except share data)

 

   Number   Amount   Stock   Capital   Deficit   Income   Interest   Equity 
   Common Stock   Treasury  

Additional

Paid-in

   Accumulated  

Accumulated

Other

Comprehensive

   Non-Controlling   Total 
   Number   Amount   Stock   Capital   Deficit   Income   Interest   Equity 
Balance as of April 1, 2023   30,738,585   $3   $(25)  $217,339   $(179,455)  $53   $4,113   $42,028 
Issuance of common stock upon exercise of options   42,500           -         -    217           -          -    -    217 
At the market equity offering stock issuance of common stock, net   930,232    -    -    5,813    -    -    -    5,813 
Stock-based compensation   -    -    -    5,580    -    -    535    6,115 
Other comprehensive income   -    -    -    -    -    25    -    25 
Net loss   -    -    -    -    (14,095)   -    (960)   (15,055)
Balance as of June 30, 2023   31,711,317   $3   $(25)  $228,949   $(193,550)  $78   $3,688   $39,143 

 

   Common Stock   Treasury  

Additional

Paid-in

   Accumulated  

Accumulated

Other

Comprehensive

   Non-Controlling   Total 
   Number   Amount   Stock   Capital   Deficit   Income   Interest   Equity 
Balance as of July 1, 2023   31,711,317   $3   $(25)  $228,949   $(193,550)  $78   $3,688   $39,143 
At the market equity offering stock issuance of common stock, net   261,117    -    -    688    -    -    -    688 
Stock-based compensation   -    -    -    5,858    -    -    603    6,460 
Other comprehensive loss   -    -    -    -    -    (35)   -    (35)
Net loss   -    -    -    -    (16,220)   -    (1,205)   (17,426)
Balance as of September 30, 2023   31,972,434   $3   $(25)  $235,495   $(209,770)  $43   $3,085   $28,831 

 

   Common Stock   Treasury  

Additional

Paid-in

   Accumulated  

Accumulated

Other

Comprehensive

   Non-Controlling   Total 
   Number   Amount   Stock   Capital   Deficit   Income   Interest   Equity 
Balance as of October 1, 2023   31,972,434   $3   $(25)  $235,495   $(209,770)  $43   $3,085   $28,831 
Issuance of common stock upon vesting of restricted shares   346,900                     -    -    -        -    -    - 
At the market equity offering stock issuance of common stock, net   3,158,789    1    -    5,472    -    -    -    5,473 
Stock-based compensation   -    -    -    5,825    -    -    610    6,435 
Other comprehensive loss   -    -    -    -    -    (9)   -    (9)
Net loss   -    -    -    -    (16,220)   -    (1,038)   (17,258)
Balance as of December 31, 2023   35,478,123   $4   $(25)  $246,792   $(225,990)  $34  $2,657   $23,471 

 

6

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(UNAUDITED)

FOR THE THREE AND NINE MONTHS ENDED DECEMBER 31, 2022

(amounts in thousands, except share data)

 

   Common Stock   Treasury  

Additional

Paid-in

   Accumulated  

Accumulated

Other

Comprehensive

   Non-
Controlling
   Total 
   Number   Amount   Stock   Capital   Deficit   Income   Interest   Equity 
Balance as of April 1, 2022   29,886,173   $     3   $    (25)  $196,269   $(123,639)  $        96   $5,505   $78,209 
Issuance of common stock upon exercise of options – cashless   1,831    -    -    -    -    -    -    - 
Stock-based compensation   -    -    -    4,178    -    -    445    4,624 
Other comprehensive income   -    -    -    -    -    172    -    172 
Net loss   -    -    -    -    (10,934)   -    (720)   (11,654)
Balance as of June 30, 2022   29,888,004   $3   $(25)  $200,448   $(134,573)  $268   $5,230   $71,351 

 

   Common Stock   Treasury  

Additional

Paid-in

   Accumulated  

Accumulated

Other

Comprehensive

   Non-
Controlling
   Total 
   Number   Amount   Stock   Capital   Deficit   Income   Interest   Equity 
Balance as of July 1, 2022   29,888,004   $     3   $    (25)  $200,448   $(134,573)  $     268   $5,230   $71,351 
At the market issuance of common stock, net   19,300    -    -    214                   214 
Issuance of common stock upon exercise of options – cashless   3,903    -    -    -    -    -    -    - 
Stock-based compensation   -    -    -    4,268    -    -    446    4,714 
Other comprehensive income   -    -    -    -    -    171    -    171 
Net loss   -    -    -    -    (11,968)   -    (830)   (12,797)
Balance as of September 30, 2022   29,911,207   $3   $(25)  $204,930   $(146,541)  $438   $4,847   $63,652 

 

   Common Stock   Treasury  

Additional

Paid-in

   Accumulated  

Accumulated

Other

Comprehensive

   Non-
Controlling
   Total 
   Number   Amount   Stock   Capital   Deficit   Income   Interest   Equity 
Balance as of October 1, 2022   29,911,207   $     3   $     (25)  $204,930   $(146,541)  $            438   $4,847   $63,652 
Issuance of common stock upon vesting of restricted shares   102,700    -    -                     
Stock-based compensation   -    -    -    5,167    -    -    699    5,866 
Other comprehensive loss   -    -    -    -    -    (280)   -    (280)
Net loss   -    -    -    -    (12,747)   -    (1,051)   (13,798)
Balance as of December 31, 2022   30,013,907   $3   $(25)  $210,097   $(159,288)  $159   $4,495   $55,440 

 

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

 

7

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

(amounts in thousands)

 

   2023   2022 
   For the Nine Months Ended 
   December 31, 
   2023   2022 
         
Cash flows from operating activities          
Net loss  $(49,739)  $(38,250)
Adjustments to reconcile net loss to net cash used in operating activities          
Depreciation and amortization   1,185    439 
Amortization of licensed right to use technology   154    154 
Stock-based compensation   19,010    15,204 
Amortization of debt discount and accretion of debt issuance costs   779    - 
Change in fair value of warrant liability   (693)   - 
Change in fair value of derivative liability   (1,147)   - 
Amortization of operating lease assets   276    237 
Foreign currency adjustments   (13)   144 
Write-off of assets no longer used   -    235 
Unrealized gain/(loss) in marketable securities   99    (38)
Provision for inventory losses   -    49 
Changes in:          
Grant receivable   420    (33)
Inventory   (404)   (607)
Accounts receivable   (294)   - 
Other current assets and prepaid expenses   (1,749

)

   491 
Accounts payable   340    (338)
Accrued expenses   (13,237)   (2,256)
Operating lease liability   (276)   - 
Net cash used in operating activities  $(45,289)  $(24,569)
           
Cash flows from investing activities          
Purchase of marketable securities   (74,470)   (32,777)
Proceeds from sale of marketable securities   67,716    5,188 
Security deposits made on operating leases   -    (4)
Purchase of property and equipment   (3,814)   (1,855)
Net cash used in investing activities  $(10,568)  $(29,447)
           
Cash flows from financing activities          
Proceeds from issuance of common stock through at the market offerings   11,973    214 
Proceeds from issuance of common stock through exercise of stock options   217    - 
Proceeds from loan   15,818    - 
Payment of loan   (735)   (927)
Net cash provided by and (used in) financing activities  $27,274   $(713)
           
Effect of exchange rate changes on cash and cash equivalents   18    63 
           
Decrease in cash, cash equivalents and restricted cash  $(28,565)  $(54,667)
Cash, cash equivalents and restricted cash at beginning of period   36,768    87,711 
Cash, cash equivalents and restricted cash at end of period  $8,202   $33,044 
Supplemental disclosure of non-cash investing and financing activities          
Debt discount  $4,541   $- 
End of term loan liability  $(613)  $- 
Warrant liability  $(885)  $- 
Derivative liability  $(1,361)  $- 
Right-of-use assets  $-   $466 
Operating lease liability  $-   $466 
Fixed Assets included in Accounts Payable and accrued expenses 

927 

   $-

Supplemental disclosure of cash flow items:          
Interest paid  $1,195   $25 
Income taxes paid  $-   $87 

 

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

 

8

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 1 ORGANIZATION AND BUSINESS

 

Beyond Air, Inc. (together with its subsidiaries, “Beyond Air” or the “Company”) was incorporated on April 28, 2015, under Delaware law. On June 25, 2019, the Company’s name was changed to Beyond Air, Inc. from AIT Therapeutics, Inc.

 

The Company is a commercial-stage medical device and biopharmaceutical company developing a platform of nitric oxide (“NO”) generators and delivery systems (the “LungFit® platform”) capable of generating NO from ambient air. The Company’s first device, LungFit® PH (“LungFit® PH”) received premarket approval (“PMA”) from the U.S. Food and Drug Administration (“FDA”) in June 2022. The NO generated by the LungFit® PH system is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. This condition is commonly referred to as persistent pulmonary hypertension of the newborn (“PPHN”). The LungFit® platform can generate NO up to 400 parts per million (“ppm”) for delivery to a patient’s 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. In July 2022, the Company commenced marketing LungFit® PH in the United States for PPHN as a medical device.

 

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’s other areas of focus with the LungFit® platform beyond PPHN are viral community-acquired pneumonia (“VCAP”) including COVID-19, bronchiolitis (“BRO”), nontuberculous mycobacteria (“NTM”) lung infection and those with various severe lung infections with underlying chronic obstructive pulmonary disease (“COPD”).

 

With Beyond Air’s focus on NO and its effect on the human condition, the Company has two additional programs that do not utilize the LungFit® system. Through the Company’s majority-owned affiliate Beyond Cancer, Ltd. (“Beyond Cancer”) NO is used to target solid tumors. The LungFit® platform is not utilized for the solid tumor indication due to the need for ultra-high concentrations of gaseous nitric oxide (“UNO”). A proprietary delivery system has been developed that is designed to safely deliver UNO in excess of 10,000 ppm directly to a solid tumor. This program has advanced to a phase 1 human clinical trial.

 

On November 4, 2021, Beyond Air reorganized its oncology business into a new private company called Beyond Cancer. Beyond Air’s preclinical oncology team and the exclusive right to the intellectual property portfolio utilizing UNO for the treatment of solid tumors now reside with Beyond Cancer. Beyond Air has 80% ownership in Beyond Cancer.

 

The second program which does not utilize the LungFit® platform partially inhibits neuronal nitric oxide synthase (nNOS) in the brain to treat neurological conditions. The first target indication is autism spectrum disorder (“ASD”). On June 15, 2023, the Company announced that it has entered into an agreement with Yissum Research Development Company of the Hebrew University of Jerusalem, LTD. (the “University”) to acquire the commercial rights for nNOS inhibitors being developed for the treatment of ASD and other neurological conditions. Currently, there are no FDA-approved therapies specifically for the treatment of ASD. Under the terms of the agreement, Beyond Air will make payments to the University over the three-year period from the date of the agreement for pre-clinical work. Also, the Company will pay a low single-digit royalty on net sales and certain one-time payments based on clinical, regulatory and sales milestones. The Company expects this program to progress from preclinical to a phase 1 first-in-human clinical trial by 2025.

 

The Company’s current product candidates will be subject to premarket reviews and approvals by the FDA, certification through the conduct of a conformity assessment by a notified body in the European Union (the “EU”), as well as comparable foreign regulatory authorities’ reviews or approvals in other countries or regions.

 

9

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES

 

Basis of Presentation

 

The unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) for interim financial information and with the instructions to the Form 10-Q. Accordingly, they do not include all 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 sheet as of December 31, 2023 has been derived from the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended March 31, 2023 (the “2023 Annual Report”), filed with the U.S. Securities and Exchange Commission on June 22, 2023. The unaudited condensed consolidated financial statements and related disclosures should be read in conjunction with the Company’s audited consolidated financial statements and the related notes thereto included in the 2023 Annual Report.

 

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 and a variable interest entity (“VIE”) for which the Company is the primary beneficiary. As the Company has both the power to direct activities of Beyond Cancer that most significantly impact Beyond Cancer’s economic performance and the right to receive benefits and losses that may potentially be significant, these financial statements are fully consolidated with those of the Company. The non-controlling owners’ 20% interest in Beyond Cancer’s net assets and results of operations is reported as “non-controlling interest” on the Company’s unaudited condensed consolidated balance sheets and as “net loss attributable to non-controlling interest” in the Company’s unaudited condensed consolidated statements of operations and comprehensive loss. All intercompany balances and transactions have been eliminated in the accompanying unaudited condensed consolidated financial statements.

 

Reclassifications

 

Certain prior period amounts have been reclassified to conform to the current period presentation. These reclassifications had no effect on the reported results of operations.

 

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, contingency recognition and the determination of deferred tax attributes and the valuation allowance thereon.

 

Liquidity Risks and Uncertainties

 

The Company used cash in operating activities of $45.3 million for the nine months ended December 31, 2023, and has accumulated losses attributable to the stockholders of Beyond Air of $226.0 million. The Company had cash, cash equivalents and marketable securities of $31.3 million as of December 31, 2023. In addition, $5.2 million of cash is held on deposit by their contract manufacturer to be applied against future purchases.

 

The Company expects to incur net losses and have significant cash outflows for at least the next eighteen months, including making significant investments in research and development. Management believes these factors raise substantial doubt about the Company’s ability to meet its obligations with cash on hand and concluded that the Company will require additional funding within one year from the date these financial statements are issued.

 

Management is confident that the efforts to arrange financing as described below, while not assured, will enable them to meet the Company’s obligations.

 

Management currently has various funding options in place to raise additional capital such as a debt line of $22.5 million with Avenue Capital (Note 10), an ATM sales agreement with $34.3 million of available funds (Note 4), assets that can be leveraged such as Beyond Cancer, Autism, LungFit PH ex-US partnerships, LungFit PRO ex-US partnerships and LungFit GO partnerships. Additionally, in January 2023 the Company filed a shelf registration statement on form S-3, which allows the Company to offer and sell up to $200,000,000 of its equity or equity-linked securities.

 

With respect to Beyond Cancer, discussions are underway with investment banks to raise capital based on their most recent top line data from the phase 1a, first-in-human trial which was successful in the first 6 patients with no dose limiting toxicities at the first dose. Treatment in the next dosing cohort has begun.

 

The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue operating as a going concern. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of liabilities in the normal course of business.

 

10

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

Other Risks and Uncertainties

 

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

 

The Company’s products require approval or clearance from the FDA prior to commencement of commercial sales in the United States. There can be no assurance that the Company’s products beyond LungFit® PH in the U.S. will receive the required approvals or clearances. Certifications, 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 certifications or approvals or clearances or such certifications, approvals or clearances are delayed, such denial or delay may have a material adverse impact on the Company’s results of operations, financial position and liquidity. 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.

 

Conditions in Israel may materially and adversely affect the Company’s business.

 

In October 2023, Hamas conducted several terrorist attacks in Israel resulting in ongoing war across the country, forcing the closure of the Company’s offices in Israel for several days. Any armed conflicts, terrorist activities or political instability involving Israel or other countries in the region could adversely affect the Company’s business. Moreover, the Company has a significant number of employees located in Israel. The Company’s operations could also be disrupted by the absence for significant periods of one or more key employees or a significant number of other employees because of military service. While there are business continuity plans in place to address the military call-ups, any of these circumstances could have a material adverse effect on the Company’s business.

 

Fair Value Measurements

 

ASC 820, Fair Value Measurements and Disclosures (“ASC 820”), defines fair value as the price that would be received to sell an asset, or paid to transfer a liability, in the principal or most advantageous market in an orderly transaction between market participants on the measurement date. The fair value standard also establishes a three-level hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The valuation hierarchy is based upon the transparency of inputs to the valuation of an asset or liability on the measurement date. The three levels are defined as follows:

 

Level 1—inputs to the valuation methodology are quoted prices (unadjusted) for an identical asset or liability in an active market.

 

Level 2—inputs to the valuation methodology include quoted prices for a similar asset or liability in an active market or model-derived valuations in which all significant inputs are observable for substantially the full term of the asset or liability.

 

Level 3—inputs to the valuation methodology are unobservable and significant to the fair value measurement of the asset or liability.

 

As of December 31, 2023 and March 31, 2023, the Company’s financial instruments included cash and cash equivalents, restricted cash, marketable securities, accounts payable, long-term debt, liability classified warrants and derivative liabilities. The carrying amounts reported in the accompanying unaudited condensed consolidated financial statements for cash and cash equivalents, restricted cash and marketable securities approximate their respective fair values because of the short-term nature of these accounts. The carrying value of the Company’s long-term debt approximates fair value based on current interest rates for similar types of borrowings and is in Level 3 of the fair value hierarchy. The liability classified warrants and derivative liabilities are each recorded at their fair value and are Level 3 of the fair value hierarchy.

 

11

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

The following table presents, for each of the fair value hierarchy levels required under ASC 820, the Company’s assets and liabilities that are measured at fair value on a recurring basis:

 

The fair value amounts as of December 31, 2023 are:

 

(in thousands)  Total   Level 1   Level 2   Level 3 
                 
Marketable securities :                    
Corporate debt securities  $-   $-   $-   $- 
Government securities   12,903    12,903    -    - 
Mutual funds   10,388    10,338    -    - 
Total assets measured and recorded at fair value  $23,292   $23,292   $-   $- 
                     
Liabilities :                    
Warrant liability  $192   $-   $-   $192 
Derivative liability   214    -    -    214 
Total liabilities measured and recorded at fair value  $406   $-   $-   $406 

 

The fair value amounts as of March 31, 2023 are:

 

(in thousands)  Total   Level 1   Level 2   Level 3 
                 
Marketable securities :                    
Corporate debt securities  $1,597   $1,597   $-   $- 
Government securities   1,013    1,013    -    - 
Mutual funds   14,114    14,114    -    - 
Total assets measured and recorded at fair value  $16,724   $16,724   $-   $- 
                     
Liabilities :                    
Warrant liability  $-   $-   $-   $- 
Derivative liability   -    -    -    - 
Total liabilities measured and recorded at fair value  $-   $-   $-   $- 

 

Level 3 Valuation

 

The common stock warrants issued in connection with the Loan and Security Agreement (as defined below) in June 2023 (Note 10) are recorded as a warrant liability within the unaudited condensed consolidated balance sheet as of December 31, 2023 as the warrants contain certain settlement features that are not indexed to the Company’s own stock. In addition, the conversion feature embedded within the long-term debt required bifurcation as certain adjustments to the conversion price were not indexed to the Company’s own stock and recorded as a derivative liability. The warrants and derivative liability are remeasured each reporting period with the change in fair value recorded to other income (expense) in the condensed consolidated statement of operations and comprehensive loss until the warrants and derivative are exercised, expired, reclassified or otherwise settled. The significant assumptions used in valuing the warrants and derivative were as follows:

 

   Warrants   Derivative 
Expected term (in years)   4.5    3.5 
Volatility   81%   81%
Risk-free rate   3.88%   3.97%

 

The table presented below is a summary of changes in the fair value of the Company’s Level 3 valuation for the warrants and derivatives for the nine months ended December 31, 2023 (in thousands):

 

   Warrants   Derivative 
Issuances  $885   $1,361 
Change in fair value   (693)   (1,147)
Balance at December 31, 2023  $192   $214 

 

12

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

Warrant Liability

 

The Company classifies warrants as equity any contracts that (i) require physical settlement or net-share settlement or (ii) gives the Company a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). The Company classifies warrants as assets or liabilities any contracts that (i) require net-cash settlement (including a requirement to net-cash settle the contract if an event occurs and if that event is outside the control of the Company) or (ii) gives the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). Such warrants are subject to remeasurement at each condensed consolidated balance sheet date and any change in fair value is recognized as a component of other expense on the condensed consolidated statements of operations and comprehensive loss. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of such warrants. At that time, the portion of the warrant liability related to warrants will be reclassified to additional paid-in capital.

 

Derivative Liability

 

The Company evaluates its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives in accordance with ASC 815, Derivatives and Hedging. For derivative financial instruments that are accounted for as assets or liabilities, the derivative instrument is initially recorded at its fair value on the grant date and is then re-valued at each reporting date, with changes in the fair value reported in the condensed consolidated statements of operations and comprehensive loss. The classification of derivative instruments, including whether such instruments should be recorded as assets or liabilities or as equity, is evaluated at the end of each reporting period. Derivative liabilities classified in the condensed consolidated balance sheets as current or non-current based on whether or not net-cash settlement or conversion of the instrument could be required within 12 months of the balance sheet date.

 

Cash and Cash Equivalents, Short-Term Investments and Restricted Cash

 

The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase and an investment in a U.S. government money market fund to be cash equivalents. The Company maintains its cash and cash equivalents in highly rated financial institutions in Australia, Israel, Ireland and the U.S., the balances of which, at times, may exceed federally insured limits. Marketable securities include investment in fixed income bonds and U.S. Treasury securities that are considered to be highly liquid and easily tradeable. The marketable securities are considered trading securities and are measured at fair value and are accounted for in accordance with ASC 320. The marketable securities are valued using inputs observable in active markets for identical securities and are therefore classified as Level 1 within the Company’s fair value hierarchy.

 

As of December 31, 2023 and March 31, 2023, restricted cash included approximately $0.2 million and $7.6 million, respectively. Restricted cash declined by $7.4 million from March 31, 2023 to December 31, 2023, as a $7.4 million supersedeas bond held as collateral pending the outcome of the appeal on Empery Asset Master, Ltd., et. al. vs. AIT Therapeutics, Inc. (the “Empery Suit”) was released in satisfaction of judgement in April 2023 (Note 10).

 

The following table is the reconciliation of the presentation and disclosure of cash, cash equivalents, marketable securities by major security type and restricted cash as shown on the Company’s condensed consolidated statements of cash flows for:

 

(in thousands) 

December 31,

2023

  

March 31,

2023

 
Cash and cash equivalents  $7,971   $29,158 
Restricted cash   231    7,610 
Total cash, cash equivalents and restricted cash  $8,202   $36,768 
Marketable securities:          
Marketable debt securities   -    - 
Corporate debt securities  $-   $1,597 
U.S. government securities   12,903    1,013 
Mutual fund (ultra-short-term income)   10,388    14,114 
Total marketable securities  $23,292   $16,724 
           
Total cash, cash equivalents, marketable securities and restricted cash  $31,494   $53,492 

 

13

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

The following table summarizes the Company’s short-term marketable securities with unrealized gains and losses as of December 31, 2023, aggregated by major security type:

 

(in thousands)  Fair Value  

Unrealized
Gains and

(Losses)

 
Corporate debt securities  $-   $- 
U.S. government securities   12,903    79 
Mutual fund (ultra-short-term income)   10,388    20 
Total short-term marketable securities  $23,292   $99 

 

The following table summarizes the Company’s short-term marketable securities with unrealized gains and losses as of March 31, 2023, aggregated by major security type:

 

(in thousands)  Fair Value  

Unrealized
Gains and

(Losses)

 
Corporate debt securities  $1,597   $2 
U.S. government securities   1,013    10 
Mutual fund (ultra-short-term income)   14,114    - 
Total short-term marketable securities  $16,724   $12 

 

All marketable securities are A- or higher rated. No marketable securities have maturities greater than 12 months. All investments are level 1 investments.

 

Revenue Recognition

 

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

 

The Company will be required to use 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 the transaction price in step (iv) above. The Company will also be required to use judgment to determine whether variable consideration 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 contract are satisfied.

 

Segment Reporting

 

Commencing with the creation of Beyond Cancer in November 2021, the Company’s operations became classified into two segments, Beyond Air and Beyond Cancer. Each segment has its own management team, board of directors, corporate officers and legal entities. As of December 31, 2023, Beyond Air, Inc. owns 80% of the common stock of Beyond Cancer. The segment reporting is based on the manner in which the Company’s CEO as chief operating decision maker assesses performance and allocates resources across the organization. The Beyond Air segment includes unallocated corporate expenses associated with the public company fees as well as all corporate related assets and liabilities.

 

The following table summarizes segment financial information by business segment as of December 31, 2023:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Cash, cash equivalents, marketable securities and restricted cash  $18,081   $13,413   $31,494 
All other assets   19,781    636    20,417 
Total assets  $37,862   $14,048   $51,911 
Total liabilities  $(27,596)  $(844)  $(28,440)
Net assets  $10,266   $13,205   $23,471 
Non-controlling interest  $-   $2,657   $2,657 

 

14

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

The following table summarizes segment financial information by business segment as of March 31, 2023:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Cash, cash equivalents, marketable securities and restricted cash  $32,998   $20,494   $53,492 
All other assets   14,700    557    15,257 
Total assets  $47,699   $21,051   $68,749 
Total liabilities  $(26,201)  $(520)  $(26,721)
Net assets  $21,498   $20,530   $42,028 
Non-controlling interest  $-   $4,113   $4,113 

 

The following table summarizes segment financial performance by business segment for the nine months ended December 31, 2023:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Revenue  $689   $-   $689 
Net loss for the nine months ended December 31, 2023  $(33,721)  $(16,018)  $(49,739)

 

The following table summarizes segment financial performance by business segment for the three months ended December 31, 2023:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Revenue  $391   $-   $391 
Net loss for the three months ended December 31, 2023  $(12,065)  $(5,193)  $(17,258)

 

The following table summarizes segment financial performance by business segment for the nine months ended December 31, 2022:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
             
Revenue  $-   $-   $- 
Net loss for the nine months ended December 31, 2022  $(25,246)  $(13,004)  $(38,250)

 

The following table summarizes segment financial performance by business segment for the three months ended December 31, 2022:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Revenue  $-   $-   $- 
Net loss for the three months ended December 31, 2022  $(8,543)  $(5,255)  $(13,798)

 

Research and Development

 

Research and development expenses are charged to the condensed consolidated statements of operations and comprehensive loss as incurred. Research and development expenses include salaries, benefits, stock-based compensation and costs incurred by outside laboratories, manufacturers, clinical research organizations, consultants, and accredited facilities in connection with preclinical studies and clinical trials. Research and development 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. In the three months ended December 31, 2023 and December 31, 2022, the Company received $0 and $0 thousand, respectively, in AU Tax Rebates. In the nine months ended December 31, 2023 and December 31, 2022, the Company received $0 and $182 thousand, respectively, in AU Tax Rebates.

 

15

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

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 date fair value of the award. Fair value for restricted stock unit awards is valued using the closing price of the Company’s common stock on the date of grant. The 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, using the accelerated method with each tranche being expensed over its vesting period. The grant 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. Starting in 2023, Beyond Air solely used its own historical volatility as the input for expected volatility, but due to Beyond Cancer’s lack of marketability, the Company utilizes the implied volatility based on an aggregate of guideline companies for expected volatility. The Company uses the simplified method to estimate the expected term.

 

Supplier Concentration

 

The Company relies on third-party suppliers to provide materials for its devices and consumables.

 

In the three months ended December 31, 2023, the Company purchased approximately 92% of its materials from two third-party vendors, with these vendors representing 87% and 5%, respectively. In the three months ended December 31, 2022, the Company purchased approximately 87% of its materials from two third-party vendors, with these vendors representing 76% and 11%, respectively.

 

In the nine months ended December 31, 2023, the Company purchased approximately 89% of its materials from two third-party vendors, with these vendors representing 80% and 9%, respectively. In the nine months ended December 31, 2022, the Company purchased approximately 78% of its materials from two third-party vendors, with these vendors representing 65% and 13%, respectively.

 

Recently Adopted Accounting Standards

 

In August 2020, the FASB issued ASU 2020-06 (“ASU 2020-06”), Debt — Debt with Conversion and Other Options (“Subtopic 470-20”), to address the complexity associated with applying U.S.GAAP to certain financial instruments with characteristics of liabilities and equity, which the Company adopted on April 1, 2023. ASU 2020-06 eliminated the beneficial conversion (and cash conversion) accounting models in Subtopic 470-20 that require separate accounting for embedded conversion features, and simplified the settlement assessment to determine whether it qualifies for equity classification. In addition, the new guidance requires entities to use the if-converted method to calculate earnings per share for all convertible instruments and to include the effect of share settlement for instruments that may be settled in cash or shares. The Company adopted ASU 2020-06 using the modified retrospective approach and applied the guidance to all financial instruments that were outstanding as of the beginning of 2023. As the Company had not previously separated any financial instruments under the beneficial conversion or cash conversion accounting models, there was no cumulative effect adjustment to the opening balance of retained earnings as a result of adopting ASU 2020-06.

 

Recently Issued Accounting Standards not yet Adopted

 

In November 2023, the FASB issued ASU-2023-07, Improvements to Reportable Segment Disclosures (Topic 280), to improve reportable segment disclosures about significant segment expenses. The amendments in this update will require public entities to disclose significant segment expenses that are regularly provided to the Company’s Chief Executive Officer as the Company’s Chief Operating Decision Maker (CODM). This guidance is effective for fiscal years beginning after December 15, 2023, (fiscal 2025 for the Company), and interim periods with fiscal years beginning after December 15, 2024, with early adoption permitted and will be applied retrospectively to all prior periods presented in the financial statements. The Company is evaluating the impact of adopting this new accounting guidance on its Consolidated Financial Statements.

 

In December 2023, the FASB issued ASU 2023-09, Improvements to Tax Disclosures (Topic 740), to enhance the transparency and decision usefulness of income tax disclosures through changes to the rate reconciliation and income taxes paid information. This guidance is effective for fiscal years beginning after December 15, 2024 (fiscal 2026 for the Company), with early adoption permitted. The Company is evaluating the impact of adopting this new accounting guidance on its Consolidated Financial Statements.

 

NOTE 3 PROPERTY AND EQUIPMENT

 

Property and equipment consist of the following:

 

(in thousands) 

December 31,

2023

   March 31,
2023
 
         
Clinical and medical equipment  $2,041   $1,365 
Equipment deployable as part of a service offering   6,938    3,027 
Computer equipment   869    779 
Furniture and fixtures   532    505 
Leasehold improvements   617    581 
Property and equipment, gross   10,997    6,256 
Accumulated depreciation   (2,446)   (1,254)
Property and equipment, net  $8,551   $5,003 

 

Depreciation and amortization for the three months ended December 31, 2023 and December 31, 2022 was $0.5 million and $0.2 million, respectively.

 

Depreciation and amortization for the nine months ended December 31, 2023 and December 31, 2022 was $1.2 million and $0.4 million, respectively. For the nine months ended December 31, 2022, upon retirement of clinical equipment determined to have no remaining useful life, $0.4 million of clinical equipment was removed less $0.1 million of accumulated depreciation and the resulting charge of $0.2 million was recorded in research and development in the accompanying statement of operations and comprehensive loss.

 

16

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 4 STOCKHOLDERS’ EQUITY

 

On February 4, 2022, the Company entered into the 2022 ATM, allowing the Company to sell its common stock for aggregate sales proceeds of up to $50.0 million from time to time and at various prices, subject to the conditions and limitations set forth in the 2022 ATM. If shares of the Company’s common stock are sold, there is a 3% fee paid to the sales agent.

 

For the nine months ended December 31, 2023, the Company received net proceeds of $12.0 million from the sale of 4,350,138 shares of common stock. As of December 31, 2023, there were $34.3 million in funds available under the 2022 ATM. For the nine months ended December 31, 2022, the Company received net proceeds of $0.2 million from the sale of 19,300 shares of common stock.

 

The Company received net proceeds of $0.2 million for 42,500 shares of common stock from the exercise of stock options in May 2023. In addition, 346,900 shares of restricted stock units vested during the quarter ended December 31, 2023.

 

Stock Option Plans

 

The Company’s Fifth Amended and Restated 2013 Beyond Air Equity Incentive Plan (the “2013 BA Plan”) allows for awards to officers, directors, employees, and consultants of stock options, restricted stock units and restricted shares of the Company’s common stock. On January 9, 2023, the Company’s Board of Directors approved an amendment to the 2013 BA Plan to increase the number of shares in the 2013 BA Plan by 3,000,000, which was approved by the Company’s stockholders at the 2023 annual stockholder meeting on March 9, 2023. The 2013 BA Plan has 10,600,000 shares authorized for issuance. As of December 31, 2023, 567,308 shares were available under the 2013 BA Plan.

 

Restricted Stock Units

 

The fair value for the restricted stock unit awards was valued at the closing price of the Company’s common stock on the date of grant. Restricted stock units vest annually over five years.

 

A summary of the Company’s restricted stock unit awards for the quarterly period ended December 31, 2023 is as follows:

 

  

Number Of

Shares

  

Weighted

Average Grant

Date Fair

Value

 
         
Unvested as of April 1, 2023   1,101,100   $6.78 
Granted   1,000    5.65 
Vested   (346,900)   6.49 
Forfeited   (6,800)   5.06 
Unvested as of December 31, 2023   748,400   $6.92 

 

Stock-based compensation expense related to these stock issuances for the three months ended December 31, 2023 and December 31, 2022 was $0.7 million and $0.6 million respectively.

 

Stock-based compensation expense related to these stock issuances for the nine months ended December 31, 2023 and December 31, 2022 was $2.2 million and $2.0 million respectively. The unrecognized compensation cost is $2.8 million and the weighted average remaining service period is 2 years.

 

17

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 4 STOCKHOLDERS’ EQUITY (continued)

 

A summary of the change in options for the nine months ended December 31, 2023,is as follows:

 

  

Number of

Options

  

Weighted

Average

Exercise

Price of

Options

  

Weighted

Average

Remaining

Contractual

Life of

Options

  

Aggregate

Intrinsic

Value

(in thousands)

 
                 
Options outstanding as of April 1, 2023   8,198,881   $5.83    8.4   $8,306 
Granted   132,500    3.95    -    - 
Exercised   (42,500)   5.10    -    - 
Forfeited   (310,787)   5.87    -    - 
Outstanding as of December 31, 2023   7,978,094   $5.82    7.4   $- 
Exercisable as of December 31, 2023   4,765,344   $5.46    6.4   $- 

 

The Company’s 2021 Beyond Cancer Ltd Equity Incentive Plan (the “2021 BC Plan”) allows for awards to officers, directors, employees, and consultants of stock options, restricted stock units and restricted shares of Beyond Cancer’s common shares. The vesting terms of the options issued under the 2021 BC Plan are generally four years and expire ten years from the grant date. On December 1, 2021, Beyond Cancer’s Board of Directors approved to reserve for issuance 2,000,000 common shares. On November 3, 2022, Beyond Cancer’s Board of Directors approved to reserve for issuance an additional 2,000,000 common shares. The 2021 BC Plan has 4,000,000 common shares authorized for issuance. As of December 31, 2023, 170,500 common shares were available under the 2021 BC Plan.

 

  

Number of

Options

  

Weighted

Average

Exercise

Price of

Options

  

Weighted

Average

Remaining

Contractual

Life of

Options

  

Aggregate

Intrinsic

Value

(thousands)

 
                 
Options outstanding as of April 1, 2023   3,817,000   $2.88    9.2   $23,486 
Granted   155,000    5.50    -    - 
Exercised   -    -    -    - 
Forfeited   (142,500)   5.33    -    - 
Outstanding as of December 31, 2023   3,829,500   $5.50    8.5   $- 
Exercisable as of December 31, 2023   1,349,250   $5.50    8.3   $- 

 

As of December 31, 2023, the Company had unrecognized stock-based compensation expense in the 2013 BA Plan of approximately $8.8 million which was expected to be expensed over the weighted average remaining service period of 1.8 years.

 

As of December 31, 2023, the Company had unrecognized stock-based compensation expense in the 2021 BC Plan of approximately $11.2 million which is expected to be expensed over the weighted average remaining service period of 1.22 years. On September 7, 2023, Beyond Cancer’s Board of Directors approved a modification to the exercise prices of all previously issued options to $5.50 per share. For the nine months ended December 31, 2023 and December 31, 2022, the weighted average fair value of options granted was $4.60 and $8.35 per share, respectively. In line with ASC718, the company has amended the stock compensation expense to reflect this de minimis adjustment.

 

18

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 4 STOCKHOLDERS’ EQUITY (continued)

 

The following was utilized to calculate the fair value of options on the date of grant:

 

   December 31,
2023
   December 31,
2022
 
Risk-free interest rate   4.34.9%   2.54.3%
Expected volatility (Beyond Air)   81.481.7%   87.4 - 89.2%
Expected volatility (Beyond Cancer)   104.3106.2 %   104.7-109.1%
Dividend yield   0%   0%
Expected terms (in years)   6.25    6.25 

 

The following summarizes the components of stock-based compensation expense which included stock options and restricted stock units for the three and nine months ended December 31, 2023 and December 31, 2022:

 

(in thousands)  2023   2022   2023   2022 
   Three Months Ended   Nine Months Ended 
   December 31,   December 31, 
(in thousands)  2023   2022   2023   2022 
Research and development  $1,428   $1,290   $4,013   $3,247 
General and administrative   5,007    4,576    14,997    11,957 
Total stock-based compensation expense  $6,435   $5,866   $19,010   $15,204 

 

Warrants

 

A summary of the Company’s outstanding warrants as of December 31, 2023 is as follows:

 

Warrant Holders 

Number of

Warrants

  

Exercise

Price

  

Intrinsic Value

(in thousands)

  

Date of

Expiration

 
                 
Third-party license agreement   208,333   $4.80   $       -    January 2024 
March 2020 loan   172,187   $7.26    -    March 2025 
NitricGen agreement   80,000   $6.90    -    January 2028 
Avenue agreement   233,843   $5.88    -    June 2028 
Total   694,363   $6.02   $-      

 

Warrants to purchase up to 233,843 of Company common stock were issued to Avenue Venture Opportunities Fund, L.P., a Delaware limited partnership (“Avenue”), and Avenue Venture Opportunities Fund II, L.P, a Delaware limited partnership (“Avenue 2” and, together with Avenue, the “Lenders”) in the nine months ended December 31, 2023 and are liability classified. No warrants were exercised in this period. All other warrants outstanding are equity classified. There were zero warrants issued or exercised in the nine months ended December 31, 2022.

 

19

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 5 OTHER CURRENT ASSETS AND PREPAID EXPENSES

 

A summary of current assets and prepaid expenses as of December 31, 2023 and March 31, 2023 is as follows (in thousands):

 

  

December 31,

2023

  

March 31,

2023

 
Research and development  $119   $128 
Insurance   216    908 
Prepaid rents and tenant improvement   49    - 
Prepaid marketing materials   90    - 
Value added tax receivable   240    231 
Demonstration materials   211    245 
Deposits to secure manufacturing materials   5,019    2,519 
Other   174    337 
Total  $6,118   $4,369 

 

NOTE 6 ACCRUED EXPENSES

 

A summary of the accrued expenses as of December 31, 2023 and March 31, 2023 is as follows (in thousands):

 

  

December 31,

2023

  

March 31,

2023

 
Research and development  $746   $426 
Professional fees   619    1,221 
Employee salaries and benefits   1,247    985 
Contingent litigation and settlements (Note 10)   400    10,298 
Circassia settlement – current portion (Note 8)   4,500    3,500 
Goods received not invoiced   85    - 
Other   285    184 
Total short-term accrued expenses  $7,882   $16,613 
           
Circassia settlement – long-term portion (Note 8)  $-   $4,500 
Total other long-term liabilities  $-   $4,500 

 

20

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 7 BASIC AND DILUTED NET INCOME (LOSS) PER SHARE OF COMMON STOCK

 

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

 

  

December 31,

2023

  

December 31,

2022

 
         
Common stock warrants   694,363    460,520 
Common stock options   7,978,094    5,645,131 
Restricted shares   748,400    769,500 
Loan and Security – conversion feature (Note 10)   392,465    - 
Total   9,813,322    6,875,151 

 

NOTE 8 LICENSE AGREEMENT

 

On January 23, 2019, the Company entered into an agreement for commercial rights (the “Circassia Agreement”) with Circassia Limited and its affiliates (collectively, “Circassia”) for 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 Circassia Agreement.

 

On May 25, 2021, the Company and Circassia entered into a settlement agreement (the “Settlement Agreement”) resolving all claims by and between both parties and mutually terminating the Circassia Agreement. Pursuant to the terms of the Settlement Agreement, the Company agreed to pay Circassia $10.5 million in three instalments, and the first payment of $2.5 million was triggered upon FDA approval (fixing the “Initial Payment Due Date” at July 28, 2022). Thereafter, the Company is to pay $3.5 million to Circassia on the first anniversary of the Initial Payment Due Date and $4.5 million on the second anniversary of the Initial Payment Due Date. Additionally, beginning in year three post-approval, Circassia will receive a quarterly royalty payment equal to 5% of LungFit® PH net sales in the U.S. This royalty will terminate once the aggregate payment reaches $6.0 million. $2.5 million was paid to Circassia in July 2022, $3.5 million was paid in August 2023 and the final $4.5 million is payable in the second fiscal quarter of 2025. As of December 31, 2023 and March 31, 2023 $4.5 million and $8.0 million respectively are included in accrued liabilities.

 

NOTE 9 GRANT COLLABORATION AGREEMENT

 

On February 10, 2021, the Company received a grant for up to $2.2 million from the Cystic Fibrosis Foundation (“CFF”) to advance the clinical development of high concentration NO for the treatment of NTM pulmonary disease, which disproportionally affects cystic fibrosis patients. Under the terms of the agreement, the funding will be allocated to the ongoing LungFit® GO NTM pilot clinical trial. The grant provides milestones based upon achieving performance steps and requirements under a development program. The grant provides for royalty payments to CFF upon the commercialization of any product developed under the grant program at a rate of 10% of net sales. The royalties are capped at four times the grant actually paid to the Company. A total of $1.7 million has been recognized as a reduction of research and development costs from this grant to date. Since the beginning of the pilot clinical trial, the Company has received milestone payments totaling $1.7 million.

 

21

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 10 COMMITMENTS AND CONTINGENCIES

 

License Agreements

 

In August 2015, Beyond Air Ltd., a wholly-owned subsidiary of the Company (“BA Ltd.”) entered into an Option Agreement (the “Option Agreement”) with Pulmonox Technologies Corporation (“Pulmonox”) whereby BA Ltd. acquired the option (the “Option”) to purchase certain intellectual property assets and rights. On January 13, 2017, BA Ltd. exercised the Option and paid $500 thousand to Pulmonox. BA Ltd. became obligated to make certain one-time development and sales milestone payments to Pulmonox, commencing with the date on which BA Ltd. receives regulatory approval for the commercial sale of the first product candidate qualifying under the Option Agreement. These milestone payments are capped at a total of $87 million across three separate and distinct indications that fall under the agreement, with the majority of them, approximately $83 million, being sales-related based on cumulative sales milestones for each of the three products. BA Ltd. is not currently developing any qualifying products.

 

On January 31, 2018, the Company 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®. The Company acquired the licensing right to use the technology and agreed to pay NitricGen a total of $2.0 million in future payments based upon achieving certain milestones, as defined in the NitricGen Agreement, and single-digit royalties on sales of the LungFit®. The Company paid NitricGen $100 thousand upon the execution of the NitricGen Agreement, $100 thousand upon achieving the next milestone and $1.5 million in January 2023, six months after approval of the LungFit® by the FDA) and issued 100,000 warrants to purchase the Company’s common stock valued at $0.3 million upon executing the NitricGen Agreement. As of December 31, 2023, the remaining future milestone payments total $0.3 million.

 

Supply Agreement and Purchase Order

 

In August 2020, the Company entered into a supply agreement expiring on December 31, 2024. The agreement will renew automatically for successive three-year periods unless and until the Company provides 12 months’ notice of intent not to renew. The Company has opened several non-cancellable purchase orders and the outstanding amount remaining under the purchase order as of December 31, 2023 was approximately $5.5 million with this supplier. This supplier holds $5.1 million of cash deposits to partially secure materials on the Company’s behalf.

 

Contingencies

 

In April 2023, the Company paid a total of $7.6 million including damages and interest in satisfaction of judgment in resolution of the Empery Suit. This had been accrued as of March 31, 2023.

 

In December 2021, Hudson Bay Master Fund (“Hudson”) filed a lawsuit in the Supreme Court on the State of New York against the Company relating to the notice of adjustment of the exercise price of and the number of warrant shares issuable under warrants issued to Hudson in January 2017. Hudson received 83,334 warrants in connection with the January 2017 offering. Hudson’s complaint alleged breach of contract and that Hudson is entitled to damages and interest as a result of certain adjustments to the exercise price and number of warrant shares issuable following a February 2018 financing transaction. The lawsuit was settled in July 2023 and $3.1 million was paid for defense and indemnity costs in the quarter ended September 30, 2023. As of December 31, 2023 and March 31, 2023 $0 and $2.7 million respectively are included in accrued liabilities.

 

From time to time, the Company is involved in various legal matters arising in the normal course of business. The Company does not expect the outcome of such proceedings, either individually or in aggregate, to have a material effect on its financial position, cash flows or results of operations.

 

22

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 10 COMMITMENTS AND CONTINGENCIES (continued)

 

Loan and Security Agreement

 

On June 15, 2023 (the “Closing Date”), the Company entered into a Loan and Security Agreement (the “Loan and Security Agreement”) with Avenue Capital Management II, L.P., as administrative agent and collateral agent (the “Agent”), and the Lenders. Also on June 15, 2023, the Company entered into a Supplement to the Loan and Security Agreement (collectively with the Agreement, the “Loan Agreement”) with the Agent and the Lenders. The Loan Agreement provides for senior secured term loans (the “Loans”) in an aggregate principal amount up to $40.0 million, with (i) $17.5 million advanced on the Closing Date (“Tranche 1”), (ii) up to $10.0 million which may be advanced upon the request of the Company between April 1, 2024 and December 31, 2024, subject to the Company having achieved total revenue derived from the sale of LungFit® PH (other than licensing revenue) (“Product Revenue”) for the three-month period prior to funding of not less than 85% of projected Product Revenue for such period (“Tranche 2”), and (iii) up to $12.5 million which may be advanced after April 1, 2024 (the “Discretionary Tranche”), subject to (a) the Agent and Lenders having received investment committee approval and (b) the Company and Lenders having mutually agreed to draw and fund, such amount. The Loans are due and payable on June 1, 2027 (the “Maturity Date”). The Loan principal is repayable in equal monthly instalments beginning on January 1, 2025, with the possibility of deferring principal payments an additional 6 to 18 months contingent upon the Company’s achievement of at least $40.0 million of Product Revenue in the fiscal year ending March 31, 2025, provided the Company has fully drawn Tranche 2. The Loans bear interest at a rate per annum (subject to increase during an event of default) equal to the greater of (i) the prime rate, as published by the Wall Street Journal from time to time, plus 3.75% and (ii) 12.00%. The Company may, subject to certain parameters, voluntarily prepay the Loans, in whole or in part, at any time. If prepayment occurs on or before the one-year anniversary of the Closing Date, the Company is required to pay a fee equal to the principal amount of the Loans prepaid multiplied by 3.00%; if prepayment occurs after the one-year anniversary of the Closing Date and on or before the two-year anniversary of the Closing Date, the Company is required to pay a fee equal to the principal amount of the Loans prepaid multiplied by 2.00%; if prepayment occurs after the two-year anniversary and on or before the three-year anniversary of the Closing Date, the Company is required to pay a fee equal to the principal amount of the Loans prepaid multiplied by 1.50%; and if prepayment occurs after the three-year anniversary of the Closing Date and before the Maturity Date, the Company is required to pay a fee equal to the principal amount of the Loans prepaid multiplied by 1.00%. A final payment fee of 3.50% of the principal amount of the Tranche 1 and Tranche 2 Loans is also due upon the Maturity Date or any earlier date of prepayment (in the case of any partial prepayment, solely with respect to the principal amount being prepaid). The Loans are guaranteed by the Company’s subsidiaries, Beyond Air Ltd. and Beyond Air Ireland Limited, and certain of the Company’s future subsidiaries (collectively, the “Guarantors”). The Company’s obligations under the Loan Agreement and the guarantee of such obligations are secured by a pledge of substantially all of the Company’s assets and have been or will be secured by a pledge of substantially all of the assets of the Guarantors.

 

Pursuant to the Loan Agreement, the Company is subject to a financial covenant requiring the Company to maintain at all times $5.0 million in unrestricted cash. The Loan Agreement also contains affirmative and negative covenants customary for financings of this type that, among other things, limit the ability of the Company and its subsidiaries to (i) incur additional debt, guarantees or liens; (ii) pay any dividends; (iii) enter into certain change of control transactions; (iv) sell, transfer, lease, license, or otherwise dispose of certain assets; (v) make certain investments or loans; and (vi) engage in certain transactions with related persons, in each case, subject to certain exceptions.

 

The Loan Agreement also includes events of default customary for financings of this type, in certain cases subject to customary periods to cure, following which the Agent may accelerate all amounts outstanding under the Loans. The Company granted the Lenders warrants to purchase an aggregate of 233,843 shares of common stock at an exercise price of the lesser of $5.88 or the price per share of the Company’s next bona fide round of equity financing before June 30, 2024.

 

The Company also granted the Lenders conversion rights for up to $3.0 million in aggregate of the principal amount in common stock at a price equal to 130% of the exercise price of the warrant (392,465 shares of common stock at $7.644), for the life of the loan.

 

The warrants are freestanding liability classified financial instruments to which a portion of the debt proceeds were allocated to warrants and based on the warrants estimated fair value at issuance. The remaining proceeds were allocated to the long-term debt. Costs allocated to the warrants were expensed immediately and costs allocated to the debt are recorded as a debt discount and are amortized into interest expense over the life of the debt using the effective interest method. The conversion feature was bifurcated from the debt and is accounted for as a derivative liability (Note 2).

 

23

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 10 COMMITMENTS AND CONTINGENCIES (continued)

 

The Company received $15.8 million in net proceeds on June 15, 2023 after all fees and advanced interest had been deducted.

 

Maturity of Long-Term Loan (in thousands)  December 31, 2023 
     
2025  $1,750 
2026   7,000 
2027   7,000 
2028   1,750 
Total  $17,500 

 

Components of Loan and Security Agreement

 

  

December 31,

2023

  

June 15,

2023 (Closing)

 
         
Amount outstanding  $17,500   $17,500 
Debt discount   (4,541)   (4,541)
Amortization of debt discount   779    - 
Final payment liability   613    613 
Total  $14,351   $13,572 

 

24

 

 

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 (this “Form 10-Q”) contains “forward-looking statements.” Beyond Air, Inc (together with its subsidiaries, “Beyond Air”, “the “Company” or “we”) intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained 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 Form 10-Q, including statements regarding our future results of operations and financial position, business strategy, prospective product 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 Form 10-Q 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. These forward-looking statements speak only as of the date of this Form 10-Q and are subject to a number of important factors that could cause actual results to differ materially from those in the forward-looking statements, including the factors described under the sections in this Form 10-Q titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” Item 1A “Risk Factors” contained in our most recently filed Annual Report on Form 10-K, as well as the following:

 

  our ability to successfully commercialize our LungFit® PH system in the U.S.;
  our ability to obtain CE Certificate of Conformity to CE mark LungFit® in the European Union (the “EU”);
  our expectation to incur losses for the next few years;
  our ability to predict accurately the demand for our products, and products under development and to develop strategies to address markets successfully;
  the possibility that products may contain undetected errors or defects or otherwise not perform as anticipated;
  the anticipated development of markets we sell our products into and the success of our products in these markets;
  our future capital needs and our need to raise additional funds;
  our ability to build a pipeline of product candidates and develop and commercialize our approved products;
  our ability to enroll patients in clinical trials, timely and successfully complete those trials and receive necessary certifications or 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 U.S Food and Drug Administration (“FDA”) regulation of our approved product and product candidates;
  our ability to obtain and retain key executives and attract and retain qualified personnel; and
  our ability to successfully manage our growth, including as a commercial-stage company.

 

Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties.

 

You should read this Form 10-Q and the documents that we reference in this 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 our 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 any 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 Form 10-Q are the property of Beyond Air, Inc. This 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 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.

 

25

 

 

Introduction

 

We are a commercial-stage medical device and biopharmaceutical company developing a platform of nitric oxide (“NO”) generators and delivery systems (the “LungFit® platform”) capable of generating NO from ambient air. Our first device, LungFit® PH received premarket approval (“PMA”) from the FDA in June 2022. The NO generated by the LungFit® PH system is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. This condition is commonly referred to as persistent pulmonary hypertension of the newborn (“PPHN”). The LungFit® platform can generate NO up to 400 parts per million (“ppm”) for delivery to a patient’s 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. In July 2022, we commenced marketing LungFit® PH in the United States for PPHN as a medical device.

 

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® platform can potentially address. Our current areas of focus with LungFit® are PPHN, viral community-acquired pneumonia (“VCAP”) including COVID-19, bronchiolitis (“BRO”), nontuberculous mycobacteria (“NTM”) lung infection and those with various severe lung infections with underlying chronic obstructive pulmonary disease (“COPD”). Our current product candidates will be subject to premarket reviews and approvals by the FDA, certification through the conduct of a conformity assessment by a notified body in the EU for the product to be CE marked, as well as comparable foreign regulatory authorities.

 

With Beyond Air’s focus on NO and its effect on the human condition, there are two additional programs that do not utilize our LungFit® system. Through our majority-owned affiliate Beyond Cancer, Ltd. (“Beyond Cancer”), NO is used to target solid tumors. The LungFit® platform is not utilized for the solid tumor indication due to the need for ultra-high concentrations of gaseous nitric oxide (“UNO”). A proprietary delivery system has been developed that is designed to safely deliver UNO in excess of 10,000 ppm directly to a solid tumor. This program has advanced to a phase 1 clinical trial.

 

The second program, which does not utilize the LungFit® platform, partially inhibits neuronal nitric oxide synthase (“nNOS”) in the brain to treat neurological conditions. The first target indication is autism spectrum disorder (“ASD”). ASD is a serious neurodevelopmental and behavioral disorder, and one of the most disabling conditions and chronic illnesses in children. ASD includes a wide range of developmental disorders that share a core of neurobehavioral deficits manifested by abnormalities in social interactions, deficits in communication, restricted interests, and repetitive behaviors. In 2023, the CDC reported that approximately 1 in 36 children in the U.S. is diagnosed with an ASD. The cost of caring for Americans with autism had reached $268 billion in 2015 and would rise to $461 billion by 2025 in the absence of more-effective interventions and support across the life span. We expect this program to progress from preclinical to a phase 1 first-in-human clinical trial by early 2025.

 

LungFit® PH is the first FDA-approved system using our patented ionizer technology to generate on-demand NO from ambient air and, regardless of dose or flow, deliver it to a ventilator circuit. The device uses a medical air compressor to drive room air through a plasma chamber in the center of the unit where pulses of electrical discharge are created between two electrodes. The system uses the power equivalent to a 60-watt lightbulb to ionize the nitrogen and oxygen molecules, which then combine as NO with low levels of nitrogen dioxide (“NO2”) created as a byproduct. The products are then passed through a Smart Filter, which removes the toxic NO2 from the internal circuit. With respect to PPHN, the novel 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 ability of LungFit® PH to generate NO from ambient air provides us with many competitive advantages over the current standard of NO delivery systems in the U.S., the EU, Japan and other markets. For example, 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.

 

Our novel LungFit® 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 others. We believe that current FDA-approved NO vasodilation treatments would have limited success in treating microbial infections given the low concentrations of NO being 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 our preclinical studies and clinical trials, 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 comparable foreign regulatory agencies in other countries or regions have approved any NO formulation and/or delivery system for >80 ppm NO.

 

LungFit® PH for the treatment of Persistent Pulmonary Hypertension of the Newborn (PPHN)

 

In June 2022, the FDA approved LungFit® PH to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. LungFit® PH is the inaugural device from the LungFit® platform of NO generators that use patented ionizer technology and is the first FDA-approved product for Beyond Air.

 

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We have submitted a PMA supplement to the FDA in November 2023 for the expansion of the label to include certain cardiac surgeries and we also expect to receive CE mark under the Medical Device Regulation (“MDR”) in the EU during the first half of calendar 2024. According to the most recent year-end report from Mallinckrodt Pharmaceuticals (“Mallinckrodt”), sales of NO were $339.7 million in 2022 (down from $448.5 million in 2021) for the United States, Canada, Japan, Mexico and Australia, with ~90% in the United States. Outside of the U.S. there are multiple market participants which translates to considerably lower sales than in the U.S. We believe the U.S. sales potential of LungFit® PH in PPHN to be approximately $350 million and worldwide sales potential to be approximately $700 million. We initiated the first phase of our commercial launch in July 2022, and entered into phase 2 with an expanded commercial presence during the spring of 2023 in the U.S. and will continue to work toward a potential launch in the EU and globally in 2024 and beyond.

 

LungFit® PRO for the treatment of viral lung infections in hospitalized patients

 

Viral Community-Acquired Pneumonia (including COVID-19)

 

Viral pneumonia in adults is most 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 been identified as pathogens contributing to the overall burden of adult viral pneumonia. COVID-19 is an infectious disease caused by SARS-CoV-2, that resulted in a global pandemic, causing millions of hospitalizations and over 6.6 million deaths worldwide as of January 2023 according to the World Health Organization. Excluding the pandemic, there are approximately 350,000 annual viral pneumonia hospitalizations in the U.S., and up to 16 million annual viral pneumonia hospitalizations globally. For the broader annual viral pneumonia hospitalizations, we believe U.S. market potential to be greater than $1.5 billion and worldwide market potential to be greater than $3 billion.

 

We initiated a pilot clinical trial in late 2020 using our novel LungFit® PRO system at 150 ppm to treat patients with VCAP. The trial was a multi-center, open-label, randomized clinical trial in Israel, including patients infected with COVID-19. Patients were 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, were assessed.

 

We presented results from the pilot clinical trial at the 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID 2022), which took place from April 23, 2022 through April 26, 2022 as a hybrid event both onsite in Lisbon, Portugal and online. At the time of the data cut off, the trial enrolled a total of 40 patients hospitalized for VCAP (SARS-CoV-2, n=39; other viruses n=1). The intent-to-treat population included 35 patients with 16 patients in the inhaled NO group and 19 patients in the control group. The primary COVID-19 treatments used during the clinical trial were Remdesivir (>30%) and Dexamethasone (>65%). Safety data from the clinical trial show that inhaled NO treatment was well tolerated overall with no treatment related adverse events as assessed by the investigators. There were two serious adverse events (“SAEs”) reported in the group receiving inhaled NO along with SST, which were determined to be related to underlying conditions and unrelated to clinical trial drug/device. From an efficacy perspective, results show a trend of shortening length of stay (“LOS”) by a factor 1.8 in favor of inhaled NO treatment. Duration of oxygen support, measured in-hospital and at home, was significantly shorter (p=0.0339) for inhaled NO treated patients. Patients with unstable oxygen saturation during hospitalization, 66.7% of the inhaled NO treatment group, reached stable saturation of ≥93% during hospital stay as compared to 26.7% in the SST group.

 

Following completion of the clinical trial and the 180-day follow-up period, incremental data were provided in a poster presentation at IDWeek 2022 held from October 19, 2022, through October 23, 2022 in Washington, D.C. In addition to the positive clinical results provided at ECCMID 2022, the poster showed a larger decline in c-reactive protein (“CRP”) from baseline for patients treated with NO + SST compared to the control group. Analysis of the data provides compelling evidence that high concentration NO delivery with the LungFit® PRO generator and delivery system can be a powerful tool against any type of pneumonia, especially COVID-19. The Company commenced a clinical trial in 2023 in the United States and anticipates completion of the trial in the second quarter of calendar 2025.

 

Bronchiolitis

 

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 them severe enough to require hospitalization. Worldwide, 95% of all cases occur in developing countries. In the U.S., there are approximately 120,000 annual bronchiolitis hospitalizations and approximately 3.2 million annual child hospitalizations 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 LOS. We believe the U.S. market potential for bronchiolitis to be greater than $500 million and worldwide market potential to be greater than $1.2 billion.

 

The pivotal clinical trial for bronchiolitis was originally set to be 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, 2021 through May 19, 2021. Analysis across the studies (n=198 infants, mean age 3.9 months) showed that 150 ppm – 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 LOS 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.

 

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Additionally, long-term safety data for high concentration inhaled NO in bronchiolitis was presented at the Pediatric Academic Societies Meeting 2022 (PAS 22), which was held in Denver, Colorado from April 21, 2022 through April 25, 2022. A total of 101 infants from the three prior pilot studies for bronchiolitis (n=198) participated in the long-term follow-up clinical trial. Clinical trial endpoints for the long-term safety clinical trial included percentage of patients re-hospitalized for bronchiolitis related reasons, such reasons included wheezing episodes, pneumonia, and asthma and the percentage of patients re-hospitalized for any reason. Data from the clinical trial showed the re-hospitalization rate per 100 Patient Exposure Years (PEY) due to bronchiolitis related reasons trended favorably for the inhaled NO group. In addition, the long-term patient re-hospitalization rate for any reason was similar between inhaled NO and control groups. As such, the clinical trial concluded that the treatment of hospitalized infants with acute bronchiolitis by intermittent high dose inhaled NO shows a favorable long-term safety profile.

 

We believe that the entirety of data at 150 ppm – 160 ppm NO in both adult and infant patient populations supports further development of LungFit® PRO in a pivotal clinical trial for patients hospitalized with VCAP or bronchiolitis.

 

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. 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% to 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 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 for the treatment of refractory Mycobacterium avium complex (“MAC”). Current guideline-based approaches to treat NTM lung disease involve multi-drug regimens of antibiotics that may cause severe, long lasting side effects, and treatment can be longer than 18 months. 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 clinical trial conducted between 2007 and 2016, researchers found that the prevalence of NTM in the U.S. is increasing at approximately 7.5% per year. M. abscessus treatment costs are estimated to be more than double that of MAC. A 2015 publication by co-authors from several U.S. government departments stated that cases in 2014 alone cost the U.S. healthcare system approximately $1.7 billion. For this indication, we believe U.S. sales potential to be greater than $1 billion and worldwide sales potential to be greater than $2.5 billion.

 

In December 2020 we began a 12-week, multi-center, open-label clinical trial in Australia intended 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 (“CFF”) to fund this clinical trial and advance the clinical development of inhaled NO to treat NTM pulmonary disease. The trial enrolled both cystic fibrosis (“CF”) and non-CF patients infected with MAC, M. abscessus or any strain of NTM. The clinical trial consisted of a run-in period followed by two treatment phases. The run-in period provided a baseline for the efficacy endpoints. The first treatment phase took place over a two-week period and began in the hospital setting where patients were titrated from 150 ppm NO up to 250 ppm NO over several days. During this phase patients received NO for 40 minutes, four times per day while Methemoglobin (“MetHb”) levels were monitored. Patients were 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 highest tolerated NO concentration. For the second treatment phase, a 10-week maintenance phase, the administration was twice daily. The clinical trial evaluated safety, quality of life, physical function, and bacterial load among other parameters.

 

At the American Thoracic Society International Conference 2022 (ATS 2022), which was held in San Francisco from May 13, 2022 through May 18, 2022, we presented positive interim data from the ongoing clinical trial. At the time of data cutoff on April 4, 2022, a total of 15 patients were enrolled in the pilot clinical trial. The mean age of patients was 62.1 years (range: 22 – 82 years) with the majority female (80%), a distribution consistent with real-world NTM disease. All 15 patients were successfully titrated to 250 ppm NO in the hospital setting, and no patients required dose reductions during the subsequent at-home portion of the clinical trial. Patients were followed up for 12 weeks after the 12-week treatment period was completed.

 

After completion of the clinical trial, we presented positive results at the American College of Chest Physicians (“CHEST”) annual meeting, held from October 16, 2022 through October 19, 2022, further supporting development of intermittent high dose NO for the treatment of NTM. The clinical trial demonstrated that high dose NO treatment was well-tolerated in both the home and hospital settings. During the 10-week at-home treatment period of the clinical trial, a total of 2,492 inhalations were self-administered with overall high treatment compliance (>90%). There were no SAEs related to treatment discontinuations reported over the 12-week treatment or 12-week follow up periods. Key efficacy endpoints showed strong results with improvement seen in the majority of quality-of-life domains. Respiratory function and physical function were maintained during treatment and follow-up. Trends in the reduction of microbial load were observed and one patient achieved culture conversion with three consecutive negative sputum samples. We anticipate commencing a pivotal clinical trial in calendar year 2025 following discussions with the FDA.

 

Our program in COPD is in the preclinical stage and will move forward subject to obtaining additional financing.

 

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Ultra-High Concentration NO (UNO) in solid tumors through majority-owned affiliate Beyond Cancer, Ltd.

 

In the fourth calendar quarter of 2021, Beyond Cancer, our majority-owned affiliate, raised $30.0 million in a private placement of common shares. The investors purchased a 20% equity ownership in Beyond Cancer, while Beyond Air maintained 80% equity ownership. The funding is being used to accelerate ongoing preclinical work, including the completion of IND-enabling studies, completion of a Phase 1 clinical trial, expansion of preclinical programs for combination studies, hiring of additional Beyond Cancer team members, and optimization of the delivery system, as well as for general corporate purposes.

 

Beyond Cancer will benefit from Beyond Air’s NO expertise, IP portfolio, preclinical oncology team, and regulatory progress, and will pay Beyond Air a single-digit royalty on all future revenues. Beyond Cancer is being led by a seasoned leadership team with experience in emerging healthcare companies and clinical oncology.

 

UNO has shown anticancer properties in preclinical trials by eliciting an immune response from the host. We have released preclinical data at several medical/scientific conferences showing the promise of delivering NO directly to tumors at concentrations of 20,000 ppm – 200,000 ppm. Results showed that local tumor ablation with NO conveyed anti-tumor immunity to the host. In April 2022, we presented in vivo and in vitro preclinical data at the American Association for Cancer Research (“AACR”) 2022 annual meeting. The in vivo study assessed the mode of action following a single 5-minute gaseous NO (“gNO”) treatment which provided data showing an effect on the primary tumor 14 days post-treatment. These data showed that intratumoral injections of concentrations of gNO at 20,000 and 50,000 ppm led to increased recruitment of T cells, B cells, macrophages, and dendrocytes to the primary tumor. An elevated number of T cells and B cells were also detected in the spleen and blood 21 days following gNO treatment. In addition, at the same time point, a marked reduction in the number of myeloid-derived suppressor cells was observed in the spleen. Results from the in vitro study showed that exposure of six different cancer cell lines – including human ovarian and pancreatic and mouse lung, melanoma, colon, and breast – to UNO ranging from 10,000 ppm to 100,000 ppm for up to 10 minutes resulted in a dose-dependent cytotoxic response. The higher concentration doses of gNO led to near-instant cell death, while the lower concentration doses required a longer exposure period to elicit cell death. Cell viability was assessed using two assays: XTT and clonogenic assay. After one minute of exposure to 25,000 ppm gNO, less than 10% viability was observed in all cell lines.

 

The second half of calendar year 2022 was a time of significant progress for Beyond Cancer. On August 23, 2022, we announced that the first patient was treated in a first-in-human Phase 1 clinical trial to assess the safety and immune biomarkers of UNO therapy. In November, at the annual meeting of the Society for Immunotherapy of Cancer (“SITC”), we presented new in vivo combination data that support the potential of our novel UNO therapy to treat various types of solid tumors in combination with immune checkpoint inhibitor (“ICI”) therapies, including anti-PD-1. The data presented at SITC appears to indicate that UNO in combination with anti-PD-1 treatment may lead to higher tumor regression rates and prolonged survival. Also in 2022, on December 13, we announced the publication of preclinical data in the peer-reviewed journal Cancer Cell International (CCI), which showed that our proprietary tumor ablation technology utilizing UNO induced a potent innate and adaptive immune response that prevented metastases and resulted in a statistically significant survival benefit.

 

Calendar year 2023 began with the announcement of Beyond Cancer’s entry into a sponsored research agreement with Stanford School of Medicine and the appointment of Frederick M. Dirbas, MD, Associate Professor of Surgery, Division of Surgical Oncology, Stanford School of Medicine, and Mark D. Pegram, MD, the Suzy Yuan-Huey Hung Endowed Professor of Medical Oncology at the Stanford School of Medicine, to the Beyond Cancer Scientific Advisory Board (“SAB”). In addition to the research agreement, Dr. Dirbas was named as Chair of the SAB, which provides guidance for ongoing preclinical studies as well as ongoing and planned future clinical trials in the use of UNO to treat solid tumors. The newly appointed members of the SAB will work to provide input on the clinical development of Beyond Cancer’s UNO technology, particularly as it relates to the U.S. regulatory submission.

 

In April 2023, Beyond Cancer presented additional preclinical data for UNO therapy in solid tumors during the AACR 2023 annual meeting. Data showed a statistically significant survival benefit for repeat dosing of UNO compared to anti-mCTLA-4 as monotherapy and repeat doses of UNO prolonged survival in combination with anti-PD-1 compared to gNO alone. With regard to tumor volume, statistically significant reductions were observed with repeat dosing of UNO versus anti-mPD-1 as a monotherapy and in combination with anti-CTLA-4 versus anti-CTLA-4 alone. Additionally, the data shows that short exposures between 10 seconds to one minute of tumor cells to UNO at increasing concentrations of 25,000 ppm to 100,000 ppm NO significantly upregulate mPD-L1 expression in a dose and time-dependent manner. Also, in vivo experiments exhibited a statistically significant day 1 increase in M1 macrophages, decrease in Tregs, and reduction in tumor cell viability was directionally maintained through day 5. We believe that together with the known ability of NO to activate and recruit the immune system, the data presented at this year’s AACR annual meeting appears to indicate that repeat dosing of UNO is feasible and may be effective even in difficult-to-treat, non-immunogenic tumor types.

 

In October 2023 Beyond Cancer presented positive pre-clinical data at the EORTC International Conference on Molecular Targets and Cancer Therapeutics demonstrating a statistically significant survival benefit in mice treated with UNO plus anti-PD1 versus anti PD1 alone. This was a pooled analysis of multiple studies done with 50,000 or 100,000 ppm NO for a single administration of 5 or 10 minutes. Additionally, Beyond Cancer’s second manuscript was published in the Cells Journal in an article titled Intratumoral Administration of High-Concentration Nitric Oxide and Anti-mPD-1 Treatment Improves Tumor Regression Rates and Survival in CT26 Tumor-Bearing Mice.

 

In late December 2023, the safety review committee completed its review of the first 6 human subjects treated with UNO and reported that there were no dose limiting toxicities at the 25,000 ppm NO concentration and the study may progress to the next concentration of 50,000 ppm NO.

 

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During the first week of November 2023, at the Society for Immunotherapy Conference (SITC) in San Diego, Beyond Cancer presented top line data from the phase 1a, first-in-human trial. In 5 patients, who had failed on average 6 prior treatment regimens, the data presented shows that one 5-minute intratumoral administration of 25,000 ppm nitric oxide was safe and tolerable. An immunostimulatory effect was evident over the 7-21 day observation period with upregulation of key biomarkers such as cytotoxic T-cells, T-central memory cells, M1 macrophages, and dendritic cells while downregulation of T-regulatory cells and mononuclear-myeloid-derived suppressor cells was shown. We expect to present data from the completed phase 1a study and commence phase 1b study in calendar year 2024.

 

Selective neuronal nitric oxide synthase (nNOS) inhibitor for the treatment of neurological conditions in collaboration with Hebrew University of Jerusalem

 

On June 15, 2023, we announced that we had entered into an agreement with Yissum Research Development Company of the Hebrew University of Jerusalem, LTD. (the “University”) to acquire the commercial rights for neuronal nitric oxide synthase (nNOS) inhibitors being developed for the treatment of autism spectrum disorder (“ASD”) and other neurological conditions. Currently, there are no FDA-approved therapies utilizing nNOS inhibitors specifically for the treatment of ASD. Under the terms of the agreement, Beyond Air will make payments to the University over the two-year period from the date of the agreement for preclinical work. Also, we will pay a low single-digit royalty on net sales and certain one-time payments based on clinical, regulatory and sales milestones.

 

Work is currently being done by the University in a preclinical setting. We expect the program to progress into a phase 1 first-in-human clinical trial in calendar year 2025.

 

Critical Accounting Estimates and Policies

 

A critical accounting policy and related estimates are both important to the portrayal of a company’s financial condition and results of operations and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain.

 

Our unaudited condensed consolidated financial statements are presented in accordance with generally accepted accounting principles in the United States (U.S. GAAP), and all applicable U.S. GAAP accounting standards effective as of December 31, 2023, have been taken into consideration in preparing the unaudited condensed consolidated financial statements. The preparation of unaudited 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 highlighted as significant because changes to certain judgments and assumptions inherent in these policies could affect our consolidated financial statements:

 

  Contingent loss judgments and estimates,
     
  Research and development expense recognition,
     
  Stock-based compensation valuation and attribution

 

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Results of Operations and Comprehensive Loss

 

Below are the results of operations for the three and nine months ended December 31, 2023 and December 31, 2022:

 

(in thousands)  For the Three Months Ended   For the Nine Months Ended 
   December 31,   December 31, 
   2023   2022   2023   2022 
                 
Revenue  $391   $-   $689   $- 
                     
Cost of revenue   748    68    1,483    247 
                     
Gross loss   (356)   (68)   (794)   (247)
                     
Research and development   (6,838)   (5,000)   (18,664)   (12,679)
General and administrative   (9,768)   (8,941)   (30,915)   (25,144)
Operating expenses   (16,606)   (13,941)   (49,578)   (37,823)
                     
Operating loss   (16,963)   (14,010)   (50,372)   (38,070)
                     
Other income (expense)                    
Dividend/interest income and gains on marketable securities   388    271    1,438    388 
Interest expense   (919)   (46)   (1,991)   (142)
Change in fair value of warrant liability   46    -    693    - 
Change in fair value of derivative liability   135    -    1,147    - 
Foreign exchange gain/(loss)   31    286    (3)   (108)
Estimated liability for contingent loss   (11)   (248)   (609)   (248)
Other income / (expense)   35    (52)   (42)   (71)
Total other income (expense)   (296)   211    633    (180)
                     
Benefit from income taxes   -    -    -    - 
                     
Net loss  $(17,258)  $(13,798)  $(49,739)  $(38,250)
                     
Less : net loss attributable to non-controlling interest   (1,038)   (1,051)   (3,204)   (2,601)
                     
Net loss attributable to Beyond Air, Inc.   (16,220)   (12,747)   (46,535)   (35,649)
                     
Foreign currency translation gain/ (loss)   (9)   (184)   (19)   159 
Comprehensive loss attributable to Beyond Air, Inc.  $(16,229)  $(12,931)  $(46,554)  $(35,490)
                     
Net basic and diluted loss per share attributable to Beyond Air, Inc.  $(0.50)  $(0.43)  $(1.46)  $(1.19)
                     
Weighted average number of shares, outstanding, basic and diluted   32,462,476    29,921,254    31,883,799    29,902,694 

 

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Comparison of Three and Nine Months Ended December 31, 2023 with the Three and Nine Months Ended December 31, 2022

 

Revenues and Cost of Revenues

 

$0.4 million and $0 revenue was recognized for the three months ended December 31, 2023 and December 31, 2022, respectively. Cost of revenue of $0.8 million (which included $0.2 million of costs related to PH system upgrades) and gross losses of $0.4 million were recognized for the three months ended December 31, 2023, compared to a cost of revenue of $0.1 million and gross losses of $0.1 million for the three months ended December 31, 2022.

 

$0.7 million and $0 revenue was recognized for the nine months ended December 31, 2023 and December 31, 2022, respectively. Cost of revenue of $1.5 million and gross losses of $0.8 million were recognized for the nine months ended December 31, 2023, compared to a cost of revenue of $0.2 million and gross losses of $0.2 million for the nine months ended December 31, 2022.

 

The increase was due to the commercial product launch at the end of June 2022. Cost of revenue exceeded revenue primarily driven by costs of supply chain infrastructure required to grow revenue in future periods and depreciation of devices purchased but not deployed.

 

Research and Development Expenses

 

Research and development expenses for the three months ended December 31, 2023 were $6.8 million as compared to $5.0 million for the three months ended December 31, 2022. The increase of $1.8 million was primarily attributed to an increase in spending on salaries ($0.6 million), an increase in pre-clinical spend of ($0.2 million) and spend related to clinical studies ($1.2 million) of which $0.4 million was in Beyond Air and $0.8 million was in Beyond Cancer.

 

Research and development expenses for the nine months ended December 31, 2023 were $18.7 million as compared to $12.7 million for the nine months ended December 31, 2022. The increase of $6.0 million was attributed primarily to an increase in expenditures on Clinical studies ($2.2 million), an increase in expenditure on Pre-clinical studies ($1.4 million) and increases in research and development staff, with an increase in stock-based compensation and salaries (for a total of $2.9 million), partially offset by a reduction in professional fees of $0.7 million.

 

Selling, General and Administrative Expenses

 

Selling, general and administrative expenses for the three months ended December 31, 2023 and December 31, 2022 were $9.8 million and $8.9 million, respectively. The increase of $0.8 million was attributed primarily to an increase of $0.8 million in salary costs, an increase in motor and travel expenses of $0.2 million, partially offset by a decrease in franchise taxes of $0.2 million.

 

Selling, general and administrative expenses for the nine months ended December 31, 2023 and December 31, 2022 were $30.9 million and $25.1 million, respectively. The increase of $5.8 million was attributed primarily to an increase in salaries $2.1 million ($1.6 million in Beyond Air and $0.5 million in Beyond Cancer) mainly driven by an increase of 20 positions globally, an increase in stock-based compensation of $3.0 million ($2.6 million in Beyond Air and $0.4 million in Beyond Cancer), rent ($0.2 million), marketing ($0.2 million) and consulting fees in relation to ex -U.S. expansion and patent protections ($0.6 million) offset by a reduction in motor and travel expenses of $0.2 million and insurance expenses of $0.1 million.

 

Other Income/Expense

 

Other income/(expense) for the three months ended December 31, 2023, and December 31, 2022 was an expense of $0.3 million and income of $0.2 million, respectively. The reduction in income was attributed primarily to increased dividend and interest income and gains on marketable securities of $0.1 million, a change in fair value of warrant liability of $0.1 million and derivative liability of $0.1 million on the Loan and Security Agreement (the “Loan and Security Agreement”) with Avenue Capital Management II, L.P., as administrative agent and collateral agent (the “Agent”), Avenue Venture Opportunities Fund, L.P., a Delaware limited partnership (“Avenue”), and Avenue Venture Opportunities Fund II, L.P, a Delaware limited partnership (“Avenue 2” and, together with Avenue, the “Lenders”), partially offset by increased interest expense of $0.9 million and an increase in other expenses of $0.1 million.

 

Other income/(expense) for the nine months ended December 31, 2023, and December 31, 2022 was income of $0.6 million and an expense of $0.2 million, respectively. The $0.8 million increase in income is mainly due to a change in fair value of warrant liability of $0.7 million and derivative liability of $1.1 million on the Loan and Security Agreement, in addition to $1 million of interest and dividend income from our investments in marketable securities partially offset by an increase in interest expense of $1.8 million, and $0.4 million of non-product related litigation.

 

Net Loss Attributable to Non-controlling Interest

 

Net loss attributed to non-controlling interest for the three months ended December 31, 2023, was $1.0 million, compared to $1.1 million for the three months ended December 31, 2022. Net loss attributed to non-controlling interest for the nine months ended December 31, 2023, was $3.2 million, compared to $2.6 million for the nine months ended December 31, 2022. Non-controlling interest represent 20% of the net loss of our Beyond Cancer subsidiary, which was established in November 2021.

 

32

 

 

Net Loss Attributed to Common Stockholders

 

Net loss attributed to common stockholders of Beyond Air, Inc for the three months ended December 31, 2023, was ($16.2) million or a loss of ($0.50) per share, basic and diluted. Our net loss attributed to common stockholders of Beyond Air, Inc for the three months ended December 31, 2022 was ($12.7) million or a loss of ($0.43) per share, basic and diluted.

 

Net loss attributed to common stockholders of Beyond Air, Inc for the nine months ended December 31, 2023, was ($46.5) million or a loss of ($1.46) per share, basic and diluted. Our net loss attributed to common stockholders of Beyond Air, Inc for the nine months ended December 31, 2022 was ($35.6) million or a loss of ($1.19) per share, basic and diluted.

 

Liquidity and Capital Resources

 

Cash Flows

 

Below is a summary of our cash flows activities for the nine months ended December 31, 2023 and December 31, 2022:

 

   Nine Months Ended 
   December 31, 
(in thousands)  2023   2022 
         
Net cash provided by (used in):          
Operating activities  $(45,289)  $(24,569)
Investing activities   (10,568)   (29,447)
Financing activities   27,274    (713)
Effect of exchange rate changes on cash and cash equivalents   18    63 
Net increase (decrease) in cash, cash equivalents and restricted cash  $(28,565)  $(54,667)

 

Operating Activities

 

For the nine months ended December 31, 2023 the net cash used in operating activities was $45.3 million which was primarily due to our net loss of $49.7 million, which includes $19.0 million of stock-based compensation, $0.4 million received in grant payments, $1.2 million of depreciation and amortization and $0.5 million decrease in accounts payable, $1.8 million increase in prepaid accounts, partially offset by ($3.5) million of the payment of the second tranche of a May 2021 settlement with Circassia Limited and its affiliates (“Circassia”), ($2.9) million for the Hudson Bay settlement and ($7.6) million attributable to the resolution of Empery Asset Master, Ltd. Et AL, vs AIT Therapeutics Inc.

 

For the nine months ended December 31, 2022 the net cash used in operating activities was $24.6 million which was primarily due to our net loss of $38.3 million, which includes $15.2 million of stock based compensation, $1.0 million of depreciation and amortization and $0.5 million decrease in prepaid expenses (mainly related to prepaid insurance), partially offset by ($2.5) million of the first tranche of the Circassia Settlement and ($0.6) million for inventory purchases and a ($0.3) million decrease in accounts payable.

 

Investing Activities

 

For the nine months ended December 31, 2023 and December 31, 2022, net cash used in investing activities was $10.6 million and $29.5 million, respectively. In the nine months ended December 31, 2023, the Company invested $6.8 million of excess cash in high quality, short term, U.S. dollar denominated marketable equities with high liquidity, and $3.8 million for the purchase of property and equipment, mainly LungFit PH devices. In the nine months ended December 31, 2022, we invested $27.6 million of excess cash in high quality, short-term, U.S. dollar denominated marketable equities with high liquidity, and $1.9 million for the purchase of property and equipment, including LungFit PH devices.

 

Financing Activities

 

Net cash provided by financing activities for the nine months ended December 31, 2023 was $27.3 million, mainly from the Loan and Security Agreement of which the net proceeds were $15.8 million, and the issuance of common stock in connection with the 2022 ATM (as defined below) of $12 million partially offset by $0.7 million from the payment of short-term loans. Net cash used in financing activities for the nine months ended December 31, 2022 was $0.7 million, mainly from the $0.9 million payment of loans related to the financing of directors and officers insurance, partially offset by $0.2 million of funds received from issuance of common stock through the 2022 ATM.

 

Future Funding Requirements

 

We have generated revenue of $0.7 million from the sale of products to date. We had an operating cash flow decrease of $45.3 million for the nine months ended December 31, 2023 and we have experienced an accumulated loss of $226.0 million since inception through December 31, 2023. As of December 31, 2023, we had cash, cash equivalents and marketable securities of $31.3 million and $0.2 million in restricted cash. In addition, $5.2 million of cash is held on deposit by their contract manufacturer to be applied against future purchases.

 

33

 

 

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

 

On May 25, 2021, we and Circassia entered a settlement agreement (the “Settlement Agreement”) resolving all claims by and between both parties and mutually terminating the agreement with Circassia disclosed in Note 8 above. Pursuant to the terms of the Settlement Agreement, we agreed to pay Circassia $10.5 million in three instalments, the first being a payment of $2.5 million triggered upon FDA approval (fixing the “Initial Payment Due Date” at July 28, 2022). Thereafter, we are to pay $3.5 million to Circassia on the first anniversary of the Initial Payment Due Date and $4.5 million on the second anniversary of the Initial Payment Due Date. Additionally, beginning in year three post-approval, Circassia will receive a quarterly royalty payment equal to 5% of LungFit® PH net sales in the U.S. This royalty will terminate once the aggregate payment reaches $6.0 million. $2.5 million was paid to Circassia in July 2022 and $4.5 million has been recorded as an accrued liability for three months ended December 31, 2023. $3.5 million was paid in August 2023 and the final $4.5 million will be paid in the second fiscal quarter of 2025.

 

On February 4, 2022, we entered into an At-The-Market Equity Offering Sales Agreement with Truist Securities, Inc. and Oppenheimer & Co, Inc. (the “2022 ATM”). Under the 2022 ATM, we may sell shares of our common stock having aggregate sales proceeds of up to $50.0 million, from time to time and at various prices. If shares of our common stock are sold, there is a 3% fee paid to the sales agent. As of December 31, 2023, there was a balance of $34.3 million available under the 2022 ATM.

 

On June 15, 2023 (the closing date), we entered into the Loan Agreement with the Agent and the Lenders. Also, on June 15, 2023 we entered into a Supplement to the Loan and Security Agreement (collectively with the Agreement, the “Loan Agreement) with the Agent and Lenders. The Loan agreement provides for senior secured term loans (the “Loans”) in an aggregate principal amount of up to $40 million, with (i) $17.5 million advanced on the Closing Date, (ii) up to $10 million between April 1, 2024 and September 30, 2024, subject to our achieving revenue milestones, and (iii) up to $12.5 million after April 1, 2024, subject to mutual agreement. The Loans are due and payable on June 1, 2027. The Loan principal is repayable beginning on January 1, 2025, with the possibility of deferring principal payments an additional 6 to 18 months. The Loans bear interest at a rate per annum equal to the greater of (i) the prime rate, as published by the Wall Street Journal from time to time, plus 3.75% and (ii) 12.00%. A final payment fee of 3.50% of the principal amount of the first two tranches under the Loan Agreement Loans is also due upon repayment of the principal (see Note 10).

 

We are subject to a financial covenant requiring us to maintain $5.0 million in unrestricted cash. The Loan Agreement also contains affirmative and negative covenants customary for financing of this type.

 

The Loan Agreement also includes events of default customary for financings of this type, in certain cases subject to customary periods to cure, following which the Agent may accelerate all amounts outstanding under the Loans. We granted the Lenders warrants to purchase an aggregate of 233,843 shares of common stock at an exercise price of the lesser of $5.88 or the price per share of our next bona fide round of equity financing before June 30, 2024.

 

We received $15.8 million in net proceeds on June 15, 2023 after all fees and advanced interest had been deducted.

 

Our ability to continue to operate beyond the first fiscal quarter of 2025 will be largely dependent upon the successful commercial launch of LungFit® PH, as well as obtaining partners in other parts of the world, and raising additional funds to finance our activities 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.

 

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 the completion of the research and development of our product candidates.

 

34

 

 

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

 

the progress and costs of our preclinical studies, clinical trials and other research and development activities;
the costs of commercializing the LungFit® system;
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 candidates;
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 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 candidates.

 

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 officer) and Chief Financial Officer (our principal financial 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 Exchange 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 were effective at the reasonable assurance level as of December 31, 2023.

 

Changes in Internal Control Over Financial Reporting

 

During the three months ended December 31, 2023, there were no changes made to our internal control over financial reporting that materially affected, or that are reasonably likely to materially affect our internal control over financial reporting.

 

35

 

 

PART II OTHER INFORMATION

 

ITEM 1. Legal Proceedings

 

See Note 10 to our unaudited condensed consolidated financial statements.

 

ITEM 1A. Risk Factors

 

Conditions in Israel may materially and adversely affect the Company’s business.

 

In October 2023, Hamas conducted several terrorist attacks in Israel resulting in ongoing war across the country, forcing the closure of the Company’s offices in Israel for several days. Any armed conflicts, terrorist activities or political instability involving Israel or other countries in the region could adversely affect the Company’s business. Moreover, the Company has a significant number of employees located in Israel. The Company’s operations could also be disrupted by the absence for significant periods of one or more key employees or a significant number of other employees because of military service. While there are business continuity plans in place to address the military call-ups, any of these circumstances could have a material adverse effect on the Company’s business.

 

ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None

 

ITEM 3. Defaults Upon Senior Securities

 

None.

 

ITEM 4. Mine Safety Disclosures

 

Not applicable.

 

ITEM 5. Other Information

 

Rule 10b5-1 Trading Arrangements During the quarter ended December 31, 2023, none of our directors or officers (as defined in Exchange Act Rule 16a-1(f)) adopted or terminated a Rule 10b5-1 trading arrangement or non-Rule 10b5-1 trading arrangement as defined in Item 408 of Regulation S-K.

 

36

 

 

ITEM 6. Exhibits.

 

Exhibit No.   Description
     
3.1   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.
     
3.2   Certificate 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.
     
3.3   Amended 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.
     
4.1   Form 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.
     
4.2   Form 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.
     
4.3   Form 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.
     
 4.4   Form 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.
     
4.5   Form 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.
     
4.6   Warrant to Purchase Common Stock, by and between Beyond Air, Inc. and Avenue Venture Opportunities Fund, L.P., dated as of June 15, 2023, filed as Exhibit 4.1 to our Current Report on Form 8-K, as filed with the SEC on June 20, 2023, and incorporated herein by reference.
     
4.7   Warrant to Purchase Common Stock, by and between Beyond Air, Inc. and Avenue Venture Opportunities Fund II, L.P., dated as of June 15, 2023, filed as Exhibit 4.2 to our Current Report on Form 8-K, as filed with the SEC on June 20, 2023, and incorporated herein by reference.
     
31.1*   Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
31.2*   Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
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 2002.
     
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
     
104   Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

 

* Filed herewith.

** Furnished herewith.

 

37

 

 

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: February 12, 2024 Steven Lisi
  President and Chief Executive Officer
  (Principal Executive Officer)
   
  /s/ Douglas Larson
Date: February 12, 2024 Douglas Larson
  Chief Financial Officer
  (Principal Financial and Accounting Officer)

 

38

 

Exhibit 31.1

 

CERTIFICATION

 

I, Steven Lisi, certify that:

 

  1. I have reviewed this Report on Form 10-Q of Beyond Air, Inc and subsidiaries;
     
  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
     
  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
     
  4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its condensed consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     
  (b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     
  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     
  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

  5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     
  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: February 12, 2024

 

  /s/ Steven Lisi
  Steven Lisi
  President and Chief Executive Officer
  (Principal Executive Officer)

 

 

 

 

Exhibit 31.2

 

CERTIFICATION

 

I, Douglas Larson certify that:

 

  1. I have reviewed this Report on Form 10-Q of Beyond Air, Inc and subsidiaries;
     
  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
     
  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
     
  4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  (a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant including its condensed consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     
  (b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     
  (c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     
  (d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

  5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  (a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     
  (b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: February 12, 2024

 

  /s/ Douglas Larson
  Douglas Larson
  Chief Financial Officer
  (Principal Financial and Accounting Officer)

 

 

 

Exhibit 32.1

 

CERTIFICATION

 

In connection with the accompanying Quarterly Report on Form 10-Q of Beyond Air, Inc and subsidiaries for the period ended December 31, 2023 (the “Report”), the undersigned hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to the best of my knowledge and belief, that:

 

  (1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
     
  (2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Beyond Air, Inc

 

  /s/ Steven Lisi
  Steven Lisi
  President and Chief Executive Officer
  (Principal Executive Officer)

 

February 12, 2024

 

The certification set forth above is being furnished as an Exhibit solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and is not being filed as part of the Report or as a separate disclosure document of Beyond Air, Inc. or the certifying officers.

 

 

 

 

Exhibit 32.2

 

CERTIFICATION

 

In connection with the accompanying Quarterly Report on Form 10-Q of Beyond Air, Inc and subsidiaries for the period ended December 31, 2023 (the “Report”), the undersigned hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, to the best of my knowledge and belief, that:

 

  (1) the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
     
  (2) the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Beyond Air, Inc.

 

  /s/ Douglas Larson
  Douglas Larson
  Chief Financial Officer
  (Principal Financial and Accounting Officer)

 

February 12, 2024

 

The certification set forth above is being furnished as an Exhibit solely pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and is not being filed as part of the Report or as a separate disclosure document of Beyond Air, Inc. or the certifying officers.

 

 

 

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Dec. 31, 2023
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v3.24.0.1
Condensed Consolidated Balance Sheets - USD ($)
$ in Thousands
Dec. 31, 2023
Mar. 31, 2023
Current assets    
Cash and cash equivalents $ 7,971 $ 29,158
Marketable securities 23,292 16,724
Restricted cash 231 7,610
Accounts receivable 294
Inventory, net 1,533 1,129
Grant receivable 420
Other current assets and prepaid expenses 6,118 4,369
Total current assets 39,439 59,410
Licensed right to use technology 1,478 1,632
Right-of-use lease assets 2,229 2,493
Property and equipment, net 8,551 5,003
Other assets 213 212
TOTAL ASSETS 51,911 68,749
Current liabilities    
Accounts payable 3,220 2,016
Accrued expenses 7,882 16,613
Operating lease liability, current portion 408 376
Loans payable, current portion 130 775
Total current liabilities 11,641 19,780
Operating lease liability, net 2,012 2,321
Long-term debt 14,380 120
Warrant liability 192
Derivative liability 214
Other long-term liabilities 4,500
Total liabilities 28,440 26,721
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, 35,478,123 and 30,738,585 shares issued and outstanding as of December 31, 2023 and March 31, 2023, respectively 4 3
Treasury stock (25) (25)
Additional paid-in capital 246,792 217,339
Accumulated deficit (225,990) (179,455)
Accumulated other comprehensive income 34 53
Total stockholders’ equity attributable to Beyond Air, Inc 20,814 37,915
Non-controlling interest 2,657 4,113
Total equity 23,471 42,028
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $ 51,911 $ 68,749
v3.24.0.1
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
Dec. 31, 2023
Mar. 31, 2023
Statement of Financial Position [Abstract]    
Preferred stock, par value $ 0.0001 $ 0.0001
Preferred stock, shares authorized 10,000,000 10,000,000
Preferred stock, shares issued 0 0
Preferred stock, shares outstanding 0 0
Common stock, par value $ 0.0001 $ 0.0001
Common stock, shares authorized 100,000,000 100,000,000
Common stock, shares issued 35,478,123 30,738,585
Common stock, shares outstanding 35,478,123 30,738,585
v3.24.0.1
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2023
Dec. 31, 2022
Income Statement [Abstract]        
Revenue $ 391 $ 689
Cost of revenue 748 68 1,483 247
Gross loss (356) (68) (794) (247)
Operating expenses:        
Research and development (6,838) (5,000) (18,664) (12,679)
General and administrative (9,768) (8,941) (30,915) (25,144)
Operating expenses (16,606) (13,941) (49,578) (37,823)
Operating loss (16,963) (14,010) (50,372) (38,070)
Other income (expense)        
Dividend/interest income and gains on marketable securities 388 271 1,438 388
Interest expense (919) (46) (1,991) (142)
Change in fair value of warrant liability 46 693
Change in fair value of derivative liability 135 1,147
Foreign exchange gain and loss 31 286 (3) (108)
Estimated liability for contingent loss (11) (248) (609) (248)
Other income/ (expense) 35 (52) (42) (71)
Total other income (expense) (294) 211 633 (180)
Benefit from income taxes
Net loss (17,258) (13,798) (49,739) (38,250)
Less : net loss attributable to non-controlling interest (1,038) (1,051) (3,204) (2,601)
Net loss attributable to Beyond Air, Inc. (16,220) (12,747) (46,535) (35,649)
Foreign currency translation gain /(loss) (9) (184) (19) 159
Comprehensive loss attributable to Beyond Air, Inc. $ (16,229) $ (12,931) $ (46,554) $ (35,490)
Net basic loss per share attributable to Beyond Air, Inc. $ (0.50) $ (0.43) $ (1.46) $ (1.19)
Net diluted loss per share attributable to Beyond Air, Inc. $ (0.50) $ (0.43) $ (1.46) $ (1.19)
Weighted average number of shares, outstanding basic 32,462,476 29,921,254 31,883,799 29,902,694
Weighted average number of shares, outstanding diluted 32,462,476 29,921,254 31,883,799 29,902,694
v3.24.0.1
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($)
$ in Thousands
Common Stock [Member]
Treasury Stock, Common [Member]
Additional Paid-in Capital [Member]
Retained Earnings [Member]
AOCI Attributable to Parent [Member]
Noncontrolling Interest [Member]
Total
Balance at Mar. 31, 2022 $ 3 $ (25) $ 196,269 $ (123,639) $ 96 $ 5,505 $ 78,209
Balance, shares at Mar. 31, 2022 29,886,173            
Issuance of common stock upon vesting of restricted shares
Issuance of common stock upon exercise of options - cashless, shares 1,831            
Stock-based compensation 4,178 445 4,624
Other comprehensive income (loss) 172 172
Net loss (10,934) (720) (11,654)
Balance at Jun. 30, 2022 $ 3 (25) 200,448 (134,573) 268 5,230 71,351
Balance, shares at Jun. 30, 2022 29,888,004            
Balance at Mar. 31, 2022 $ 3 (25) 196,269 (123,639) 96 5,505 78,209
Balance, shares at Mar. 31, 2022 29,886,173            
Net loss             (38,250)
Balance at Dec. 31, 2022 $ 3 (25) 210,097 (159,288) 159 4,495 55,440
Balance, shares at Dec. 31, 2022 30,013,907            
Balance at Jun. 30, 2022 $ 3 (25) 200,448 (134,573) 268 5,230 71,351
Balance, shares at Jun. 30, 2022 29,888,004            
Issuance of common stock upon vesting of restricted shares
Issuance of common stock upon exercise of options - cashless, shares 3,903            
At the market issuance of common stock, net 214       214
At the market issuance of common stock, net, shares 19,300            
Stock-based compensation 4,268 446 4,714
Other comprehensive income (loss) 171 171
Net loss (11,968) (830) (12,797)
Balance at Sep. 30, 2022 $ 3 (25) 204,930 (146,541) 438 4,847 63,652
Balance, shares at Sep. 30, 2022 29,911,207            
Issuance of common stock upon vesting of restricted shares          
Stock-based compensation 5,167 699 5,866
Other comprehensive income (loss) (280) (280)
Net loss (12,747) (1,051) (13,798)
Balance at Dec. 31, 2022 $ 3 (25) 210,097 (159,288) 159 4,495 55,440
Balance, shares at Dec. 31, 2022 30,013,907            
Balance at Mar. 31, 2023 $ 3 (25) 217,339 (179,455) 53 4,113 42,028
Balance, shares at Mar. 31, 2023 30,738,585            
Issuance of common stock upon vesting of restricted shares 217 217
Issuance of common stock upon exercise of options - cashless, shares 42,500            
At the market issuance of common stock, net 5,813 5,813
At the market issuance of common stock, net, shares 930,232            
Stock-based compensation 5,580 535 6,115
Other comprehensive income (loss) 25 25
Net loss (14,095) (960) (15,055)
Balance at Jun. 30, 2023 $ 3 (25) 228,949 (193,550) 78 3,688 39,143
Balance, shares at Jun. 30, 2023 31,711,317            
Balance at Mar. 31, 2023 $ 3 (25) 217,339 (179,455) 53 4,113 42,028
Balance, shares at Mar. 31, 2023 30,738,585            
Issuance of common stock upon vesting of restricted shares             $ 200
Issuance of common stock upon exercise of options - cashless, shares             42,500
Net loss             $ (49,739)
Balance at Dec. 31, 2023 $ 4 (25) 246,792 (225,990) 34 2,657 23,471
Balance, shares at Dec. 31, 2023 35,478,123            
Balance at Jun. 30, 2023 $ 3 (25) 228,949 (193,550) 78 3,688 39,143
Balance, shares at Jun. 30, 2023 31,711,317            
At the market issuance of common stock, net 688 688
At the market issuance of common stock, net, shares 261,117            
Stock-based compensation 5,858 603 6,460
Other comprehensive income (loss) (35) (35)
Net loss (16,220) (1,205) (17,426)
Balance at Sep. 30, 2023 $ 3 (25) 235,495 (209,770) 43 3,085 28,831
Balance, shares at Sep. 30, 2023 31,972,434            
At the market issuance of common stock, net $ 1 5,472 5,473
At the market issuance of common stock, net, shares 3,158,789            
Stock-based compensation 5,825 610 6,435
Other comprehensive income (loss) (9) (9)
Net loss (16,220) (1,038) (17,258)
Issuance of common stock upon vesting of restricted shares  
Issuance of common stock upon vesting of restricted shares, shares 346,900            
Balance at Dec. 31, 2023 $ 4 $ (25) $ 246,792 $ (225,990) $ 34 $ 2,657 $ 23,471
Balance, shares at Dec. 31, 2023 35,478,123            
v3.24.0.1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended 12 Months Ended
Dec. 31, 2023
Jun. 30, 2023
Dec. 31, 2022
Jun. 30, 2022
Dec. 31, 2023
Dec. 31, 2022
Mar. 31, 2023
Cash flows from operating activities              
Net loss $ (17,258) $ (15,055) $ (13,798) $ (11,654) $ (49,739) $ (38,250)  
Adjustments to reconcile net loss to net cash used in operating activities              
Depreciation and amortization 500   200   1,185 439  
Amortization of licensed right to use technology         154 154  
Stock-based compensation 6,435   5,866   19,010 15,204  
Amortization of debt discount and accretion of debt issuance costs         779  
Change in fair value of warrant liability (46)     (693)  
Change in fair value of derivative liability (135)     (1,147)  
Amortization of operating lease assets         276 237  
Foreign currency adjustments         (13) 144  
Write-off of assets no longer used         235  
Unrealized gain/(loss) in marketable securities         99 (38)  
Provision for inventory losses         49  
Changes in:              
Grant receivable         420 (33)  
Inventory         (404) (607)  
Accounts receivable         (294)  
Other current assets and prepaid expenses         (1,749) 491  
Accounts payable         340 (338)  
Accrued expenses         (13,237) (2,256)  
Operating lease liability         (276)  
Net cash used in operating activities         (45,289) (24,569)  
Cash flows from investing activities              
Purchase of marketable securities         (74,470) (32,777)  
Proceeds from sale of marketable securities         67,716 5,188  
Security deposits made on operating leases         (4)  
Purchase of property and equipment         (3,814) (1,855)  
Net cash used in investing activities         (10,568) (29,447)  
Cash flows from financing activities              
Proceeds from issuance of common stock through at the market offerings         11,973 214  
Proceeds from issuance of common stock through exercise of stock options         217  
Proceeds from loan         15,818  
Payment of loan         (735) (927)  
Net cash provided by and (used in) financing activities         27,274 (713)  
Effect of exchange rate changes on cash and cash equivalents         18 63  
Decrease in cash, cash equivalents and restricted cash         (28,565) (54,667)  
Cash, cash equivalents and restricted cash at beginning of period   $ 36,768   $ 87,711 36,768 87,711 $ 87,711
Cash, cash equivalents and restricted cash at end of period $ 8,202   $ 33,044   8,202 33,044 $ 36,768
Supplemental disclosure of non-cash investing and financing activities              
Debt discount         4,541  
End of term loan liability         (613)  
Warrant liability         (885)  
Derivative liability         (1,361)  
Right-of-use assets         466  
Operating lease liability         466  
Fixed Assets included in Accounts Payable and accrued expenses         927  
Supplemental disclosure of cash flow items:              
Interest paid         1,195 25  
Income taxes paid         $ 87  
v3.24.0.1
ORGANIZATION AND BUSINESS
9 Months Ended
Dec. 31, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
ORGANIZATION AND BUSINESS

NOTE 1 ORGANIZATION AND BUSINESS

 

Beyond Air, Inc. (together with its subsidiaries, “Beyond Air” or the “Company”) was incorporated on April 28, 2015, under Delaware law. On June 25, 2019, the Company’s name was changed to Beyond Air, Inc. from AIT Therapeutics, Inc.

 

The Company is a commercial-stage medical device and biopharmaceutical company developing a platform of nitric oxide (“NO”) generators and delivery systems (the “LungFit® platform”) capable of generating NO from ambient air. The Company’s first device, LungFit® PH (“LungFit® PH”) received premarket approval (“PMA”) from the U.S. Food and Drug Administration (“FDA”) in June 2022. The NO generated by the LungFit® PH system is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. This condition is commonly referred to as persistent pulmonary hypertension of the newborn (“PPHN”). The LungFit® platform can generate NO up to 400 parts per million (“ppm”) for delivery to a patient’s 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. In July 2022, the Company commenced marketing LungFit® PH in the United States for PPHN as a medical device.

 

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’s other areas of focus with the LungFit® platform beyond PPHN are viral community-acquired pneumonia (“VCAP”) including COVID-19, bronchiolitis (“BRO”), nontuberculous mycobacteria (“NTM”) lung infection and those with various severe lung infections with underlying chronic obstructive pulmonary disease (“COPD”).

 

With Beyond Air’s focus on NO and its effect on the human condition, the Company has two additional programs that do not utilize the LungFit® system. Through the Company’s majority-owned affiliate Beyond Cancer, Ltd. (“Beyond Cancer”) NO is used to target solid tumors. The LungFit® platform is not utilized for the solid tumor indication due to the need for ultra-high concentrations of gaseous nitric oxide (“UNO”). A proprietary delivery system has been developed that is designed to safely deliver UNO in excess of 10,000 ppm directly to a solid tumor. This program has advanced to a phase 1 human clinical trial.

 

On November 4, 2021, Beyond Air reorganized its oncology business into a new private company called Beyond Cancer. Beyond Air’s preclinical oncology team and the exclusive right to the intellectual property portfolio utilizing UNO for the treatment of solid tumors now reside with Beyond Cancer. Beyond Air has 80% ownership in Beyond Cancer.

 

The second program which does not utilize the LungFit® platform partially inhibits neuronal nitric oxide synthase (nNOS) in the brain to treat neurological conditions. The first target indication is autism spectrum disorder (“ASD”). On June 15, 2023, the Company announced that it has entered into an agreement with Yissum Research Development Company of the Hebrew University of Jerusalem, LTD. (the “University”) to acquire the commercial rights for nNOS inhibitors being developed for the treatment of ASD and other neurological conditions. Currently, there are no FDA-approved therapies specifically for the treatment of ASD. Under the terms of the agreement, Beyond Air will make payments to the University over the three-year period from the date of the agreement for pre-clinical work. Also, the Company will pay a low single-digit royalty on net sales and certain one-time payments based on clinical, regulatory and sales milestones. The Company expects this program to progress from preclinical to a phase 1 first-in-human clinical trial by 2025.

 

The Company’s current product candidates will be subject to premarket reviews and approvals by the FDA, certification through the conduct of a conformity assessment by a notified body in the European Union (the “EU”), as well as comparable foreign regulatory authorities’ reviews or approvals in other countries or regions.

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

v3.24.0.1
SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES
9 Months Ended
Dec. 31, 2023
Accounting Policies [Abstract]  
SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES

 

Basis of Presentation

 

The unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) for interim financial information and with the instructions to the Form 10-Q. Accordingly, they do not include all 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 sheet as of December 31, 2023 has been derived from the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended March 31, 2023 (the “2023 Annual Report”), filed with the U.S. Securities and Exchange Commission on June 22, 2023. The unaudited condensed consolidated financial statements and related disclosures should be read in conjunction with the Company’s audited consolidated financial statements and the related notes thereto included in the 2023 Annual Report.

 

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 and a variable interest entity (“VIE”) for which the Company is the primary beneficiary. As the Company has both the power to direct activities of Beyond Cancer that most significantly impact Beyond Cancer’s economic performance and the right to receive benefits and losses that may potentially be significant, these financial statements are fully consolidated with those of the Company. The non-controlling owners’ 20% interest in Beyond Cancer’s net assets and results of operations is reported as “non-controlling interest” on the Company’s unaudited condensed consolidated balance sheets and as “net loss attributable to non-controlling interest” in the Company’s unaudited condensed consolidated statements of operations and comprehensive loss. All intercompany balances and transactions have been eliminated in the accompanying unaudited condensed consolidated financial statements.

 

Reclassifications

 

Certain prior period amounts have been reclassified to conform to the current period presentation. These reclassifications had no effect on the reported results of operations.

 

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, contingency recognition and the determination of deferred tax attributes and the valuation allowance thereon.

 

Liquidity Risks and Uncertainties

 

The Company used cash in operating activities of $45.3 million for the nine months ended December 31, 2023, and has accumulated losses attributable to the stockholders of Beyond Air of $226.0 million. The Company had cash, cash equivalents and marketable securities of $31.3 million as of December 31, 2023. In addition, $5.2 million of cash is held on deposit by their contract manufacturer to be applied against future purchases.

 

The Company expects to incur net losses and have significant cash outflows for at least the next eighteen months, including making significant investments in research and development. Management believes these factors raise substantial doubt about the Company’s ability to meet its obligations with cash on hand and concluded that the Company will require additional funding within one year from the date these financial statements are issued.

 

Management is confident that the efforts to arrange financing as described below, while not assured, will enable them to meet the Company’s obligations.

 

Management currently has various funding options in place to raise additional capital such as a debt line of $22.5 million with Avenue Capital (Note 10), an ATM sales agreement with $34.3 million of available funds (Note 4), assets that can be leveraged such as Beyond Cancer, Autism, LungFit PH ex-US partnerships, LungFit PRO ex-US partnerships and LungFit GO partnerships. Additionally, in January 2023 the Company filed a shelf registration statement on form S-3, which allows the Company to offer and sell up to $200,000,000 of its equity or equity-linked securities.

 

With respect to Beyond Cancer, discussions are underway with investment banks to raise capital based on their most recent top line data from the phase 1a, first-in-human trial which was successful in the first 6 patients with no dose limiting toxicities at the first dose. Treatment in the next dosing cohort has begun.

 

The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue operating as a going concern. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of liabilities in the normal course of business.

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

Other Risks and Uncertainties

 

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

 

The Company’s products require approval or clearance from the FDA prior to commencement of commercial sales in the United States. There can be no assurance that the Company’s products beyond LungFit® PH in the U.S. will receive the required approvals or clearances. Certifications, 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 certifications or approvals or clearances or such certifications, approvals or clearances are delayed, such denial or delay may have a material adverse impact on the Company’s results of operations, financial position and liquidity. 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.

 

Conditions in Israel may materially and adversely affect the Company’s business.

 

In October 2023, Hamas conducted several terrorist attacks in Israel resulting in ongoing war across the country, forcing the closure of the Company’s offices in Israel for several days. Any armed conflicts, terrorist activities or political instability involving Israel or other countries in the region could adversely affect the Company’s business. Moreover, the Company has a significant number of employees located in Israel. The Company’s operations could also be disrupted by the absence for significant periods of one or more key employees or a significant number of other employees because of military service. While there are business continuity plans in place to address the military call-ups, any of these circumstances could have a material adverse effect on the Company’s business.

 

Fair Value Measurements

 

ASC 820, Fair Value Measurements and Disclosures (“ASC 820”), defines fair value as the price that would be received to sell an asset, or paid to transfer a liability, in the principal or most advantageous market in an orderly transaction between market participants on the measurement date. The fair value standard also establishes a three-level hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The valuation hierarchy is based upon the transparency of inputs to the valuation of an asset or liability on the measurement date. The three levels are defined as follows:

 

Level 1—inputs to the valuation methodology are quoted prices (unadjusted) for an identical asset or liability in an active market.

 

Level 2—inputs to the valuation methodology include quoted prices for a similar asset or liability in an active market or model-derived valuations in which all significant inputs are observable for substantially the full term of the asset or liability.

 

Level 3—inputs to the valuation methodology are unobservable and significant to the fair value measurement of the asset or liability.

 

As of December 31, 2023 and March 31, 2023, the Company’s financial instruments included cash and cash equivalents, restricted cash, marketable securities, accounts payable, long-term debt, liability classified warrants and derivative liabilities. The carrying amounts reported in the accompanying unaudited condensed consolidated financial statements for cash and cash equivalents, restricted cash and marketable securities approximate their respective fair values because of the short-term nature of these accounts. The carrying value of the Company’s long-term debt approximates fair value based on current interest rates for similar types of borrowings and is in Level 3 of the fair value hierarchy. The liability classified warrants and derivative liabilities are each recorded at their fair value and are Level 3 of the fair value hierarchy.

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

The following table presents, for each of the fair value hierarchy levels required under ASC 820, the Company’s assets and liabilities that are measured at fair value on a recurring basis:

 

The fair value amounts as of December 31, 2023 are:

 

(in thousands)  Total   Level 1   Level 2   Level 3 
                 
Marketable securities :                    
Corporate debt securities  $-   $-   $-   $- 
Government securities   12,903    12,903    -    - 
Mutual funds   10,388    10,338    -    - 
Total assets measured and recorded at fair value  $23,292   $23,292   $-   $- 
                     
Liabilities :                    
Warrant liability  $192   $-   $-   $192 
Derivative liability   214    -    -    214 
Total liabilities measured and recorded at fair value  $406   $-   $-   $406 

 

The fair value amounts as of March 31, 2023 are:

 

(in thousands)  Total   Level 1   Level 2   Level 3 
                 
Marketable securities :                    
Corporate debt securities  $1,597   $1,597   $-   $- 
Government securities   1,013    1,013    -    - 
Mutual funds   14,114    14,114    -    - 
Total assets measured and recorded at fair value  $16,724   $16,724   $-   $- 
                     
Liabilities :                    
Warrant liability  $-   $-   $-   $- 
Derivative liability   -    -    -    - 
Total liabilities measured and recorded at fair value  $-   $-   $-   $- 

 

Level 3 Valuation

 

The common stock warrants issued in connection with the Loan and Security Agreement (as defined below) in June 2023 (Note 10) are recorded as a warrant liability within the unaudited condensed consolidated balance sheet as of December 31, 2023 as the warrants contain certain settlement features that are not indexed to the Company’s own stock. In addition, the conversion feature embedded within the long-term debt required bifurcation as certain adjustments to the conversion price were not indexed to the Company’s own stock and recorded as a derivative liability. The warrants and derivative liability are remeasured each reporting period with the change in fair value recorded to other income (expense) in the condensed consolidated statement of operations and comprehensive loss until the warrants and derivative are exercised, expired, reclassified or otherwise settled. The significant assumptions used in valuing the warrants and derivative were as follows:

 

   Warrants   Derivative 
Expected term (in years)   4.5    3.5 
Volatility   81%   81%
Risk-free rate   3.88%   3.97%

 

The table presented below is a summary of changes in the fair value of the Company’s Level 3 valuation for the warrants and derivatives for the nine months ended December 31, 2023 (in thousands):

 

   Warrants   Derivative 
Issuances  $885   $1,361 
Change in fair value   (693)   (1,147)
Balance at December 31, 2023  $192   $214 

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

Warrant Liability

 

The Company classifies warrants as equity any contracts that (i) require physical settlement or net-share settlement or (ii) gives the Company a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). The Company classifies warrants as assets or liabilities any contracts that (i) require net-cash settlement (including a requirement to net-cash settle the contract if an event occurs and if that event is outside the control of the Company) or (ii) gives the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). Such warrants are subject to remeasurement at each condensed consolidated balance sheet date and any change in fair value is recognized as a component of other expense on the condensed consolidated statements of operations and comprehensive loss. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of such warrants. At that time, the portion of the warrant liability related to warrants will be reclassified to additional paid-in capital.

 

Derivative Liability

 

The Company evaluates its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives in accordance with ASC 815, Derivatives and Hedging. For derivative financial instruments that are accounted for as assets or liabilities, the derivative instrument is initially recorded at its fair value on the grant date and is then re-valued at each reporting date, with changes in the fair value reported in the condensed consolidated statements of operations and comprehensive loss. The classification of derivative instruments, including whether such instruments should be recorded as assets or liabilities or as equity, is evaluated at the end of each reporting period. Derivative liabilities classified in the condensed consolidated balance sheets as current or non-current based on whether or not net-cash settlement or conversion of the instrument could be required within 12 months of the balance sheet date.

 

Cash and Cash Equivalents, Short-Term Investments and Restricted Cash

 

The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase and an investment in a U.S. government money market fund to be cash equivalents. The Company maintains its cash and cash equivalents in highly rated financial institutions in Australia, Israel, Ireland and the U.S., the balances of which, at times, may exceed federally insured limits. Marketable securities include investment in fixed income bonds and U.S. Treasury securities that are considered to be highly liquid and easily tradeable. The marketable securities are considered trading securities and are measured at fair value and are accounted for in accordance with ASC 320. The marketable securities are valued using inputs observable in active markets for identical securities and are therefore classified as Level 1 within the Company’s fair value hierarchy.

 

As of December 31, 2023 and March 31, 2023, restricted cash included approximately $0.2 million and $7.6 million, respectively. Restricted cash declined by $7.4 million from March 31, 2023 to December 31, 2023, as a $7.4 million supersedeas bond held as collateral pending the outcome of the appeal on Empery Asset Master, Ltd., et. al. vs. AIT Therapeutics, Inc. (the “Empery Suit”) was released in satisfaction of judgement in April 2023 (Note 10).

 

The following table is the reconciliation of the presentation and disclosure of cash, cash equivalents, marketable securities by major security type and restricted cash as shown on the Company’s condensed consolidated statements of cash flows for:

 

(in thousands) 

December 31,

2023

  

March 31,

2023

 
Cash and cash equivalents  $7,971   $29,158 
Restricted cash   231    7,610 
Total cash, cash equivalents and restricted cash  $8,202   $36,768 
Marketable securities:          
Marketable debt securities   -    - 
Corporate debt securities  $-   $1,597 
U.S. government securities   12,903    1,013 
Mutual fund (ultra-short-term income)   10,388    14,114 
Total marketable securities  $23,292   $16,724 
           
Total cash, cash equivalents, marketable securities and restricted cash  $31,494   $53,492 

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

The following table summarizes the Company’s short-term marketable securities with unrealized gains and losses as of December 31, 2023, aggregated by major security type:

 

(in thousands)  Fair Value  

Unrealized
Gains and

(Losses)

 
Corporate debt securities  $-   $- 
U.S. government securities   12,903    79 
Mutual fund (ultra-short-term income)   10,388    20 
Total short-term marketable securities  $23,292   $99 

 

The following table summarizes the Company’s short-term marketable securities with unrealized gains and losses as of March 31, 2023, aggregated by major security type:

 

(in thousands)  Fair Value  

Unrealized
Gains and

(Losses)

 
Corporate debt securities  $1,597   $2 
U.S. government securities   1,013    10 
Mutual fund (ultra-short-term income)   14,114    - 
Total short-term marketable securities  $16,724   $12 

 

All marketable securities are A- or higher rated. No marketable securities have maturities greater than 12 months. All investments are level 1 investments.

 

Revenue Recognition

 

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

 

The Company will be required to use 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 the transaction price in step (iv) above. The Company will also be required to use judgment to determine whether variable consideration 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 contract are satisfied.

 

Segment Reporting

 

Commencing with the creation of Beyond Cancer in November 2021, the Company’s operations became classified into two segments, Beyond Air and Beyond Cancer. Each segment has its own management team, board of directors, corporate officers and legal entities. As of December 31, 2023, Beyond Air, Inc. owns 80% of the common stock of Beyond Cancer. The segment reporting is based on the manner in which the Company’s CEO as chief operating decision maker assesses performance and allocates resources across the organization. The Beyond Air segment includes unallocated corporate expenses associated with the public company fees as well as all corporate related assets and liabilities.

 

The following table summarizes segment financial information by business segment as of December 31, 2023:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Cash, cash equivalents, marketable securities and restricted cash  $18,081   $13,413   $31,494 
All other assets   19,781    636    20,417 
Total assets  $37,862   $14,048   $51,911 
Total liabilities  $(27,596)  $(844)  $(28,440)
Net assets  $10,266   $13,205   $23,471 
Non-controlling interest  $-   $2,657   $2,657 

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

The following table summarizes segment financial information by business segment as of March 31, 2023:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Cash, cash equivalents, marketable securities and restricted cash  $32,998   $20,494   $53,492 
All other assets   14,700    557    15,257 
Total assets  $47,699   $21,051   $68,749 
Total liabilities  $(26,201)  $(520)  $(26,721)
Net assets  $21,498   $20,530   $42,028 
Non-controlling interest  $-   $4,113   $4,113 

 

The following table summarizes segment financial performance by business segment for the nine months ended December 31, 2023:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Revenue  $689   $-   $689 
Net loss for the nine months ended December 31, 2023  $(33,721)  $(16,018)  $(49,739)

 

The following table summarizes segment financial performance by business segment for the three months ended December 31, 2023:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Revenue  $391   $-   $391 
Net loss for the three months ended December 31, 2023  $(12,065)  $(5,193)  $(17,258)

 

The following table summarizes segment financial performance by business segment for the nine months ended December 31, 2022:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
             
Revenue  $-   $-   $- 
Net loss for the nine months ended December 31, 2022  $(25,246)  $(13,004)  $(38,250)

 

The following table summarizes segment financial performance by business segment for the three months ended December 31, 2022:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Revenue  $-   $-   $- 
Net loss for the three months ended December 31, 2022  $(8,543)  $(5,255)  $(13,798)

 

Research and Development

 

Research and development expenses are charged to the condensed consolidated statements of operations and comprehensive loss as incurred. Research and development expenses include salaries, benefits, stock-based compensation and costs incurred by outside laboratories, manufacturers, clinical research organizations, consultants, and accredited facilities in connection with preclinical studies and clinical trials. Research and development 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. In the three months ended December 31, 2023 and December 31, 2022, the Company received $0 and $0 thousand, respectively, in AU Tax Rebates. In the nine months ended December 31, 2023 and December 31, 2022, the Company received $0 and $182 thousand, respectively, in AU Tax Rebates.

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

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 date fair value of the award. Fair value for restricted stock unit awards is valued using the closing price of the Company’s common stock on the date of grant. The 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, using the accelerated method with each tranche being expensed over its vesting period. The grant 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. Starting in 2023, Beyond Air solely used its own historical volatility as the input for expected volatility, but due to Beyond Cancer’s lack of marketability, the Company utilizes the implied volatility based on an aggregate of guideline companies for expected volatility. The Company uses the simplified method to estimate the expected term.

 

Supplier Concentration

 

The Company relies on third-party suppliers to provide materials for its devices and consumables.

 

In the three months ended December 31, 2023, the Company purchased approximately 92% of its materials from two third-party vendors, with these vendors representing 87% and 5%, respectively. In the three months ended December 31, 2022, the Company purchased approximately 87% of its materials from two third-party vendors, with these vendors representing 76% and 11%, respectively.

 

In the nine months ended December 31, 2023, the Company purchased approximately 89% of its materials from two third-party vendors, with these vendors representing 80% and 9%, respectively. In the nine months ended December 31, 2022, the Company purchased approximately 78% of its materials from two third-party vendors, with these vendors representing 65% and 13%, respectively.

 

Recently Adopted Accounting Standards

 

In August 2020, the FASB issued ASU 2020-06 (“ASU 2020-06”), Debt — Debt with Conversion and Other Options (“Subtopic 470-20”), to address the complexity associated with applying U.S.GAAP to certain financial instruments with characteristics of liabilities and equity, which the Company adopted on April 1, 2023. ASU 2020-06 eliminated the beneficial conversion (and cash conversion) accounting models in Subtopic 470-20 that require separate accounting for embedded conversion features, and simplified the settlement assessment to determine whether it qualifies for equity classification. In addition, the new guidance requires entities to use the if-converted method to calculate earnings per share for all convertible instruments and to include the effect of share settlement for instruments that may be settled in cash or shares. The Company adopted ASU 2020-06 using the modified retrospective approach and applied the guidance to all financial instruments that were outstanding as of the beginning of 2023. As the Company had not previously separated any financial instruments under the beneficial conversion or cash conversion accounting models, there was no cumulative effect adjustment to the opening balance of retained earnings as a result of adopting ASU 2020-06.

 

Recently Issued Accounting Standards not yet Adopted

 

In November 2023, the FASB issued ASU-2023-07, Improvements to Reportable Segment Disclosures (Topic 280), to improve reportable segment disclosures about significant segment expenses. The amendments in this update will require public entities to disclose significant segment expenses that are regularly provided to the Company’s Chief Executive Officer as the Company’s Chief Operating Decision Maker (CODM). This guidance is effective for fiscal years beginning after December 15, 2023, (fiscal 2025 for the Company), and interim periods with fiscal years beginning after December 15, 2024, with early adoption permitted and will be applied retrospectively to all prior periods presented in the financial statements. The Company is evaluating the impact of adopting this new accounting guidance on its Consolidated Financial Statements.

 

In December 2023, the FASB issued ASU 2023-09, Improvements to Tax Disclosures (Topic 740), to enhance the transparency and decision usefulness of income tax disclosures through changes to the rate reconciliation and income taxes paid information. This guidance is effective for fiscal years beginning after December 15, 2024 (fiscal 2026 for the Company), with early adoption permitted. The Company is evaluating the impact of adopting this new accounting guidance on its Consolidated Financial Statements.

 

v3.24.0.1
PROPERTY AND EQUIPMENT
9 Months Ended
Dec. 31, 2023
Property, Plant and Equipment [Abstract]  
PROPERTY AND EQUIPMENT

NOTE 3 PROPERTY AND EQUIPMENT

 

Property and equipment consist of the following:

 

(in thousands) 

December 31,

2023

   March 31,
2023
 
         
Clinical and medical equipment  $2,041   $1,365 
Equipment deployable as part of a service offering   6,938    3,027 
Computer equipment   869    779 
Furniture and fixtures   532    505 
Leasehold improvements   617    581 
Property and equipment, gross   10,997    6,256 
Accumulated depreciation   (2,446)   (1,254)
Property and equipment, net  $8,551   $5,003 

 

Depreciation and amortization for the three months ended December 31, 2023 and December 31, 2022 was $0.5 million and $0.2 million, respectively.

 

Depreciation and amortization for the nine months ended December 31, 2023 and December 31, 2022 was $1.2 million and $0.4 million, respectively. For the nine months ended December 31, 2022, upon retirement of clinical equipment determined to have no remaining useful life, $0.4 million of clinical equipment was removed less $0.1 million of accumulated depreciation and the resulting charge of $0.2 million was recorded in research and development in the accompanying statement of operations and comprehensive loss.

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

v3.24.0.1
STOCKHOLDERS’ EQUITY
9 Months Ended
Dec. 31, 2023
Equity [Abstract]  
STOCKHOLDERS’ EQUITY

NOTE 4 STOCKHOLDERS’ EQUITY

 

On February 4, 2022, the Company entered into the 2022 ATM, allowing the Company to sell its common stock for aggregate sales proceeds of up to $50.0 million from time to time and at various prices, subject to the conditions and limitations set forth in the 2022 ATM. If shares of the Company’s common stock are sold, there is a 3% fee paid to the sales agent.

 

For the nine months ended December 31, 2023, the Company received net proceeds of $12.0 million from the sale of 4,350,138 shares of common stock. As of December 31, 2023, there were $34.3 million in funds available under the 2022 ATM. For the nine months ended December 31, 2022, the Company received net proceeds of $0.2 million from the sale of 19,300 shares of common stock.

 

The Company received net proceeds of $0.2 million for 42,500 shares of common stock from the exercise of stock options in May 2023. In addition, 346,900 shares of restricted stock units vested during the quarter ended December 31, 2023.

 

Stock Option Plans

 

The Company’s Fifth Amended and Restated 2013 Beyond Air Equity Incentive Plan (the “2013 BA Plan”) allows for awards to officers, directors, employees, and consultants of stock options, restricted stock units and restricted shares of the Company’s common stock. On January 9, 2023, the Company’s Board of Directors approved an amendment to the 2013 BA Plan to increase the number of shares in the 2013 BA Plan by 3,000,000, which was approved by the Company’s stockholders at the 2023 annual stockholder meeting on March 9, 2023. The 2013 BA Plan has 10,600,000 shares authorized for issuance. As of December 31, 2023, 567,308 shares were available under the 2013 BA Plan.

 

Restricted Stock Units

 

The fair value for the restricted stock unit awards was valued at the closing price of the Company’s common stock on the date of grant. Restricted stock units vest annually over five years.

 

A summary of the Company’s restricted stock unit awards for the quarterly period ended December 31, 2023 is as follows:

 

  

Number Of

Shares

  

Weighted

Average Grant

Date Fair

Value

 
         
Unvested as of April 1, 2023   1,101,100   $6.78 
Granted   1,000    5.65 
Vested   (346,900)   6.49 
Forfeited   (6,800)   5.06 
Unvested as of December 31, 2023   748,400   $6.92 

 

Stock-based compensation expense related to these stock issuances for the three months ended December 31, 2023 and December 31, 2022 was $0.7 million and $0.6 million respectively.

 

Stock-based compensation expense related to these stock issuances for the nine months ended December 31, 2023 and December 31, 2022 was $2.2 million and $2.0 million respectively. The unrecognized compensation cost is $2.8 million and the weighted average remaining service period is 2 years.

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 4 STOCKHOLDERS’ EQUITY (continued)

 

A summary of the change in options for the nine months ended December 31, 2023,is as follows:

 

  

Number of

Options

  

Weighted

Average

Exercise

Price of

Options

  

Weighted

Average

Remaining

Contractual

Life of

Options

  

Aggregate

Intrinsic

Value

(in thousands)

 
                 
Options outstanding as of April 1, 2023   8,198,881   $5.83    8.4   $8,306 
Granted   132,500    3.95    -    - 
Exercised   (42,500)   5.10    -    - 
Forfeited   (310,787)   5.87    -    - 
Outstanding as of December 31, 2023   7,978,094   $5.82    7.4   $- 
Exercisable as of December 31, 2023   4,765,344   $5.46    6.4   $- 

 

The Company’s 2021 Beyond Cancer Ltd Equity Incentive Plan (the “2021 BC Plan”) allows for awards to officers, directors, employees, and consultants of stock options, restricted stock units and restricted shares of Beyond Cancer’s common shares. The vesting terms of the options issued under the 2021 BC Plan are generally four years and expire ten years from the grant date. On December 1, 2021, Beyond Cancer’s Board of Directors approved to reserve for issuance 2,000,000 common shares. On November 3, 2022, Beyond Cancer’s Board of Directors approved to reserve for issuance an additional 2,000,000 common shares. The 2021 BC Plan has 4,000,000 common shares authorized for issuance. As of December 31, 2023, 170,500 common shares were available under the 2021 BC Plan.

 

  

Number of

Options

  

Weighted

Average

Exercise

Price of

Options

  

Weighted

Average

Remaining

Contractual

Life of

Options

  

Aggregate

Intrinsic

Value

(thousands)

 
                 
Options outstanding as of April 1, 2023   3,817,000   $2.88    9.2   $23,486 
Granted   155,000    5.50    -    - 
Exercised   -    -    -    - 
Forfeited   (142,500)   5.33    -    - 
Outstanding as of December 31, 2023   3,829,500   $5.50    8.5   $- 
Exercisable as of December 31, 2023   1,349,250   $5.50    8.3   $- 

 

As of December 31, 2023, the Company had unrecognized stock-based compensation expense in the 2013 BA Plan of approximately $8.8 million which was expected to be expensed over the weighted average remaining service period of 1.8 years.

 

As of December 31, 2023, the Company had unrecognized stock-based compensation expense in the 2021 BC Plan of approximately $11.2 million which is expected to be expensed over the weighted average remaining service period of 1.22 years. On September 7, 2023, Beyond Cancer’s Board of Directors approved a modification to the exercise prices of all previously issued options to $5.50 per share. For the nine months ended December 31, 2023 and December 31, 2022, the weighted average fair value of options granted was $4.60 and $8.35 per share, respectively. In line with ASC718, the company has amended the stock compensation expense to reflect this de minimis adjustment.

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 4 STOCKHOLDERS’ EQUITY (continued)

 

The following was utilized to calculate the fair value of options on the date of grant:

 

   December 31,
2023
   December 31,
2022
 
Risk-free interest rate   4.34.9%   2.54.3%
Expected volatility (Beyond Air)   81.481.7%   87.4 - 89.2%
Expected volatility (Beyond Cancer)   104.3106.2 %   104.7-109.1%
Dividend yield   0%   0%
Expected terms (in years)   6.25    6.25 

 

The following summarizes the components of stock-based compensation expense which included stock options and restricted stock units for the three and nine months ended December 31, 2023 and December 31, 2022:

 

(in thousands)  2023   2022   2023   2022 
   Three Months Ended   Nine Months Ended 
   December 31,   December 31, 
(in thousands)  2023   2022   2023   2022 
Research and development  $1,428   $1,290   $4,013   $3,247 
General and administrative   5,007    4,576    14,997    11,957 
Total stock-based compensation expense  $6,435   $5,866   $19,010   $15,204 

 

Warrants

 

A summary of the Company’s outstanding warrants as of December 31, 2023 is as follows:

 

Warrant Holders 

Number of

Warrants

  

Exercise

Price

  

Intrinsic Value

(in thousands)

  

Date of

Expiration

 
                 
Third-party license agreement   208,333   $4.80   $       -    January 2024 
March 2020 loan   172,187   $7.26    -    March 2025 
NitricGen agreement   80,000   $6.90    -    January 2028 
Avenue agreement   233,843   $5.88    -    June 2028 
Total   694,363   $6.02   $-      

 

Warrants to purchase up to 233,843 of Company common stock were issued to Avenue Venture Opportunities Fund, L.P., a Delaware limited partnership (“Avenue”), and Avenue Venture Opportunities Fund II, L.P, a Delaware limited partnership (“Avenue 2” and, together with Avenue, the “Lenders”) in the nine months ended December 31, 2023 and are liability classified. No warrants were exercised in this period. All other warrants outstanding are equity classified. There were zero warrants issued or exercised in the nine months ended December 31, 2022.

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

v3.24.0.1
OTHER CURRENT ASSETS AND PREPAID EXPENSES
9 Months Ended
Dec. 31, 2023
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]  
OTHER CURRENT ASSETS AND PREPAID EXPENSES

NOTE 5 OTHER CURRENT ASSETS AND PREPAID EXPENSES

 

A summary of current assets and prepaid expenses as of December 31, 2023 and March 31, 2023 is as follows (in thousands):

 

  

December 31,

2023

  

March 31,

2023

 
Research and development  $119   $128 
Insurance   216    908 
Prepaid rents and tenant improvement   49    - 
Prepaid marketing materials   90    - 
Value added tax receivable   240    231 
Demonstration materials   211    245 
Deposits to secure manufacturing materials   5,019    2,519 
Other   174    337 
Total  $6,118   $4,369 

 

v3.24.0.1
ACCRUED EXPENSES
9 Months Ended
Dec. 31, 2023
Payables and Accruals [Abstract]  
ACCRUED EXPENSES

NOTE 6 ACCRUED EXPENSES

 

A summary of the accrued expenses as of December 31, 2023 and March 31, 2023 is as follows (in thousands):

 

  

December 31,

2023

  

March 31,

2023

 
Research and development  $746   $426 
Professional fees   619    1,221 
Employee salaries and benefits   1,247    985 
Contingent litigation and settlements (Note 10)   400    10,298 
Circassia settlement – current portion (Note 8)   4,500    3,500 
Goods received not invoiced   85    - 
Other   285    184 
Total short-term accrued expenses  $7,882   $16,613 
           
Circassia settlement – long-term portion (Note 8)  $-   $4,500 
Total other long-term liabilities  $-   $4,500 

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

v3.24.0.1
BASIC AND DILUTED NET INCOME (LOSS) PER SHARE OF COMMON STOCK
9 Months Ended
Dec. 31, 2023
Earnings Per Share [Abstract]  
BASIC AND DILUTED NET INCOME (LOSS) PER SHARE OF COMMON STOCK

NOTE 7 BASIC AND DILUTED NET INCOME (LOSS) PER SHARE OF COMMON STOCK

 

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

 

  

December 31,

2023

  

December 31,

2022

 
         
Common stock warrants   694,363    460,520 
Common stock options   7,978,094    5,645,131 
Restricted shares   748,400    769,500 
Loan and Security – conversion feature (Note 10)   392,465    - 
Total   9,813,322    6,875,151 

 

v3.24.0.1
LICENSE AGREEMENT
9 Months Ended
Dec. 31, 2023
License Agreement  
LICENSE AGREEMENT

NOTE 8 LICENSE AGREEMENT

 

On January 23, 2019, the Company entered into an agreement for commercial rights (the “Circassia Agreement”) with Circassia Limited and its affiliates (collectively, “Circassia”) for 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 Circassia Agreement.

 

On May 25, 2021, the Company and Circassia entered into a settlement agreement (the “Settlement Agreement”) resolving all claims by and between both parties and mutually terminating the Circassia Agreement. Pursuant to the terms of the Settlement Agreement, the Company agreed to pay Circassia $10.5 million in three instalments, and the first payment of $2.5 million was triggered upon FDA approval (fixing the “Initial Payment Due Date” at July 28, 2022). Thereafter, the Company is to pay $3.5 million to Circassia on the first anniversary of the Initial Payment Due Date and $4.5 million on the second anniversary of the Initial Payment Due Date. Additionally, beginning in year three post-approval, Circassia will receive a quarterly royalty payment equal to 5% of LungFit® PH net sales in the U.S. This royalty will terminate once the aggregate payment reaches $6.0 million. $2.5 million was paid to Circassia in July 2022, $3.5 million was paid in August 2023 and the final $4.5 million is payable in the second fiscal quarter of 2025. As of December 31, 2023 and March 31, 2023 $4.5 million and $8.0 million respectively are included in accrued liabilities.

 

v3.24.0.1
GRANT COLLABORATION AGREEMENT
9 Months Ended
Dec. 31, 2023
Grant Collaboration Agreement  
GRANT COLLABORATION AGREEMENT

NOTE 9 GRANT COLLABORATION AGREEMENT

 

On February 10, 2021, the Company received a grant for up to $2.2 million from the Cystic Fibrosis Foundation (“CFF”) to advance the clinical development of high concentration NO for the treatment of NTM pulmonary disease, which disproportionally affects cystic fibrosis patients. Under the terms of the agreement, the funding will be allocated to the ongoing LungFit® GO NTM pilot clinical trial. The grant provides milestones based upon achieving performance steps and requirements under a development program. The grant provides for royalty payments to CFF upon the commercialization of any product developed under the grant program at a rate of 10% of net sales. The royalties are capped at four times the grant actually paid to the Company. A total of $1.7 million has been recognized as a reduction of research and development costs from this grant to date. Since the beginning of the pilot clinical trial, the Company has received milestone payments totaling $1.7 million.

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

v3.24.0.1
COMMITMENTS AND CONTINGENCIES
9 Months Ended
Dec. 31, 2023
Commitments and Contingencies Disclosure [Abstract]  
COMMITMENTS AND CONTINGENCIES

NOTE 10 COMMITMENTS AND CONTINGENCIES

 

License Agreements

 

In August 2015, Beyond Air Ltd., a wholly-owned subsidiary of the Company (“BA Ltd.”) entered into an Option Agreement (the “Option Agreement”) with Pulmonox Technologies Corporation (“Pulmonox”) whereby BA Ltd. acquired the option (the “Option”) to purchase certain intellectual property assets and rights. On January 13, 2017, BA Ltd. exercised the Option and paid $500 thousand to Pulmonox. BA Ltd. became obligated to make certain one-time development and sales milestone payments to Pulmonox, commencing with the date on which BA Ltd. receives regulatory approval for the commercial sale of the first product candidate qualifying under the Option Agreement. These milestone payments are capped at a total of $87 million across three separate and distinct indications that fall under the agreement, with the majority of them, approximately $83 million, being sales-related based on cumulative sales milestones for each of the three products. BA Ltd. is not currently developing any qualifying products.

 

On January 31, 2018, the Company 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®. The Company acquired the licensing right to use the technology and agreed to pay NitricGen a total of $2.0 million in future payments based upon achieving certain milestones, as defined in the NitricGen Agreement, and single-digit royalties on sales of the LungFit®. The Company paid NitricGen $100 thousand upon the execution of the NitricGen Agreement, $100 thousand upon achieving the next milestone and $1.5 million in January 2023, six months after approval of the LungFit® by the FDA) and issued 100,000 warrants to purchase the Company’s common stock valued at $0.3 million upon executing the NitricGen Agreement. As of December 31, 2023, the remaining future milestone payments total $0.3 million.

 

Supply Agreement and Purchase Order

 

In August 2020, the Company entered into a supply agreement expiring on December 31, 2024. The agreement will renew automatically for successive three-year periods unless and until the Company provides 12 months’ notice of intent not to renew. The Company has opened several non-cancellable purchase orders and the outstanding amount remaining under the purchase order as of December 31, 2023 was approximately $5.5 million with this supplier. This supplier holds $5.1 million of cash deposits to partially secure materials on the Company’s behalf.

 

Contingencies

 

In April 2023, the Company paid a total of $7.6 million including damages and interest in satisfaction of judgment in resolution of the Empery Suit. This had been accrued as of March 31, 2023.

 

In December 2021, Hudson Bay Master Fund (“Hudson”) filed a lawsuit in the Supreme Court on the State of New York against the Company relating to the notice of adjustment of the exercise price of and the number of warrant shares issuable under warrants issued to Hudson in January 2017. Hudson received 83,334 warrants in connection with the January 2017 offering. Hudson’s complaint alleged breach of contract and that Hudson is entitled to damages and interest as a result of certain adjustments to the exercise price and number of warrant shares issuable following a February 2018 financing transaction. The lawsuit was settled in July 2023 and $3.1 million was paid for defense and indemnity costs in the quarter ended September 30, 2023. As of December 31, 2023 and March 31, 2023 $0 and $2.7 million respectively are included in accrued liabilities.

 

From time to time, the Company is involved in various legal matters arising in the normal course of business. The Company does not expect the outcome of such proceedings, either individually or in aggregate, to have a material effect on its financial position, cash flows or results of operations.

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 10 COMMITMENTS AND CONTINGENCIES (continued)

 

Loan and Security Agreement

 

On June 15, 2023 (the “Closing Date”), the Company entered into a Loan and Security Agreement (the “Loan and Security Agreement”) with Avenue Capital Management II, L.P., as administrative agent and collateral agent (the “Agent”), and the Lenders. Also on June 15, 2023, the Company entered into a Supplement to the Loan and Security Agreement (collectively with the Agreement, the “Loan Agreement”) with the Agent and the Lenders. The Loan Agreement provides for senior secured term loans (the “Loans”) in an aggregate principal amount up to $40.0 million, with (i) $17.5 million advanced on the Closing Date (“Tranche 1”), (ii) up to $10.0 million which may be advanced upon the request of the Company between April 1, 2024 and December 31, 2024, subject to the Company having achieved total revenue derived from the sale of LungFit® PH (other than licensing revenue) (“Product Revenue”) for the three-month period prior to funding of not less than 85% of projected Product Revenue for such period (“Tranche 2”), and (iii) up to $12.5 million which may be advanced after April 1, 2024 (the “Discretionary Tranche”), subject to (a) the Agent and Lenders having received investment committee approval and (b) the Company and Lenders having mutually agreed to draw and fund, such amount. The Loans are due and payable on June 1, 2027 (the “Maturity Date”). The Loan principal is repayable in equal monthly instalments beginning on January 1, 2025, with the possibility of deferring principal payments an additional 6 to 18 months contingent upon the Company’s achievement of at least $40.0 million of Product Revenue in the fiscal year ending March 31, 2025, provided the Company has fully drawn Tranche 2. The Loans bear interest at a rate per annum (subject to increase during an event of default) equal to the greater of (i) the prime rate, as published by the Wall Street Journal from time to time, plus 3.75% and (ii) 12.00%. The Company may, subject to certain parameters, voluntarily prepay the Loans, in whole or in part, at any time. If prepayment occurs on or before the one-year anniversary of the Closing Date, the Company is required to pay a fee equal to the principal amount of the Loans prepaid multiplied by 3.00%; if prepayment occurs after the one-year anniversary of the Closing Date and on or before the two-year anniversary of the Closing Date, the Company is required to pay a fee equal to the principal amount of the Loans prepaid multiplied by 2.00%; if prepayment occurs after the two-year anniversary and on or before the three-year anniversary of the Closing Date, the Company is required to pay a fee equal to the principal amount of the Loans prepaid multiplied by 1.50%; and if prepayment occurs after the three-year anniversary of the Closing Date and before the Maturity Date, the Company is required to pay a fee equal to the principal amount of the Loans prepaid multiplied by 1.00%. A final payment fee of 3.50% of the principal amount of the Tranche 1 and Tranche 2 Loans is also due upon the Maturity Date or any earlier date of prepayment (in the case of any partial prepayment, solely with respect to the principal amount being prepaid). The Loans are guaranteed by the Company’s subsidiaries, Beyond Air Ltd. and Beyond Air Ireland Limited, and certain of the Company’s future subsidiaries (collectively, the “Guarantors”). The Company’s obligations under the Loan Agreement and the guarantee of such obligations are secured by a pledge of substantially all of the Company’s assets and have been or will be secured by a pledge of substantially all of the assets of the Guarantors.

 

Pursuant to the Loan Agreement, the Company is subject to a financial covenant requiring the Company to maintain at all times $5.0 million in unrestricted cash. The Loan Agreement also contains affirmative and negative covenants customary for financings of this type that, among other things, limit the ability of the Company and its subsidiaries to (i) incur additional debt, guarantees or liens; (ii) pay any dividends; (iii) enter into certain change of control transactions; (iv) sell, transfer, lease, license, or otherwise dispose of certain assets; (v) make certain investments or loans; and (vi) engage in certain transactions with related persons, in each case, subject to certain exceptions.

 

The Loan Agreement also includes events of default customary for financings of this type, in certain cases subject to customary periods to cure, following which the Agent may accelerate all amounts outstanding under the Loans. The Company granted the Lenders warrants to purchase an aggregate of 233,843 shares of common stock at an exercise price of the lesser of $5.88 or the price per share of the Company’s next bona fide round of equity financing before June 30, 2024.

 

The Company also granted the Lenders conversion rights for up to $3.0 million in aggregate of the principal amount in common stock at a price equal to 130% of the exercise price of the warrant (392,465 shares of common stock at $7.644), for the life of the loan.

 

The warrants are freestanding liability classified financial instruments to which a portion of the debt proceeds were allocated to warrants and based on the warrants estimated fair value at issuance. The remaining proceeds were allocated to the long-term debt. Costs allocated to the warrants were expensed immediately and costs allocated to the debt are recorded as a debt discount and are amortized into interest expense over the life of the debt using the effective interest method. The conversion feature was bifurcated from the debt and is accounted for as a derivative liability (Note 2).

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 10 COMMITMENTS AND CONTINGENCIES (continued)

 

The Company received $15.8 million in net proceeds on June 15, 2023 after all fees and advanced interest had been deducted.

 

Maturity of Long-Term Loan (in thousands)  December 31, 2023 
     
2025  $1,750 
2026   7,000 
2027   7,000 
2028   1,750 
Total  $17,500 

 

Components of Loan and Security Agreement

 

  

December 31,

2023

  

June 15,

2023 (Closing)

 
         
Amount outstanding  $17,500   $17,500 
Debt discount   (4,541)   (4,541)
Amortization of debt discount   779    - 
Final payment liability   613    613 
Total  $14,351   $13,572 

 

v3.24.0.1
SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (Policies)
9 Months Ended
Dec. 31, 2023
Accounting Policies [Abstract]  
Basis of Presentation

Basis of Presentation

 

The unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) for interim financial information and with the instructions to the Form 10-Q. Accordingly, they do not include all 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 sheet as of December 31, 2023 has been derived from the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended March 31, 2023 (the “2023 Annual Report”), filed with the U.S. Securities and Exchange Commission on June 22, 2023. The unaudited condensed consolidated financial statements and related disclosures should be read in conjunction with the Company’s audited consolidated financial statements and the related notes thereto included in the 2023 Annual Report.

 

Principles of Consolidation

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 and a variable interest entity (“VIE”) for which the Company is the primary beneficiary. As the Company has both the power to direct activities of Beyond Cancer that most significantly impact Beyond Cancer’s economic performance and the right to receive benefits and losses that may potentially be significant, these financial statements are fully consolidated with those of the Company. The non-controlling owners’ 20% interest in Beyond Cancer’s net assets and results of operations is reported as “non-controlling interest” on the Company’s unaudited condensed consolidated balance sheets and as “net loss attributable to non-controlling interest” in the Company’s unaudited condensed consolidated statements of operations and comprehensive loss. All intercompany balances and transactions have been eliminated in the accompanying unaudited condensed consolidated financial statements.

 

Reclassifications

Reclassifications

 

Certain prior period amounts have been reclassified to conform to the current period presentation. These reclassifications had no effect on the reported results of operations.

 

Use of Estimates

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, contingency recognition and the determination of deferred tax attributes and the valuation allowance thereon.

 

Liquidity Risks and Uncertainties

Liquidity Risks and Uncertainties

 

The Company used cash in operating activities of $45.3 million for the nine months ended December 31, 2023, and has accumulated losses attributable to the stockholders of Beyond Air of $226.0 million. The Company had cash, cash equivalents and marketable securities of $31.3 million as of December 31, 2023. In addition, $5.2 million of cash is held on deposit by their contract manufacturer to be applied against future purchases.

 

The Company expects to incur net losses and have significant cash outflows for at least the next eighteen months, including making significant investments in research and development. Management believes these factors raise substantial doubt about the Company’s ability to meet its obligations with cash on hand and concluded that the Company will require additional funding within one year from the date these financial statements are issued.

 

Management is confident that the efforts to arrange financing as described below, while not assured, will enable them to meet the Company’s obligations.

 

Management currently has various funding options in place to raise additional capital such as a debt line of $22.5 million with Avenue Capital (Note 10), an ATM sales agreement with $34.3 million of available funds (Note 4), assets that can be leveraged such as Beyond Cancer, Autism, LungFit PH ex-US partnerships, LungFit PRO ex-US partnerships and LungFit GO partnerships. Additionally, in January 2023 the Company filed a shelf registration statement on form S-3, which allows the Company to offer and sell up to $200,000,000 of its equity or equity-linked securities.

 

With respect to Beyond Cancer, discussions are underway with investment banks to raise capital based on their most recent top line data from the phase 1a, first-in-human trial which was successful in the first 6 patients with no dose limiting toxicities at the first dose. Treatment in the next dosing cohort has begun.

 

The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue operating as a going concern. This basis of accounting contemplates the recovery of the Company’s assets and the satisfaction of liabilities in the normal course of business.

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

Other Risks and Uncertainties

Other Risks and Uncertainties

 

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

 

The Company’s products require approval or clearance from the FDA prior to commencement of commercial sales in the United States. There can be no assurance that the Company’s products beyond LungFit® PH in the U.S. will receive the required approvals or clearances. Certifications, 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 certifications or approvals or clearances or such certifications, approvals or clearances are delayed, such denial or delay may have a material adverse impact on the Company’s results of operations, financial position and liquidity. 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.

 

Conditions in Israel may materially and adversely affect the Company’s business.

 

In October 2023, Hamas conducted several terrorist attacks in Israel resulting in ongoing war across the country, forcing the closure of the Company’s offices in Israel for several days. Any armed conflicts, terrorist activities or political instability involving Israel or other countries in the region could adversely affect the Company’s business. Moreover, the Company has a significant number of employees located in Israel. The Company’s operations could also be disrupted by the absence for significant periods of one or more key employees or a significant number of other employees because of military service. While there are business continuity plans in place to address the military call-ups, any of these circumstances could have a material adverse effect on the Company’s business.

 

Fair Value Measurements

Fair Value Measurements

 

ASC 820, Fair Value Measurements and Disclosures (“ASC 820”), defines fair value as the price that would be received to sell an asset, or paid to transfer a liability, in the principal or most advantageous market in an orderly transaction between market participants on the measurement date. The fair value standard also establishes a three-level hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The valuation hierarchy is based upon the transparency of inputs to the valuation of an asset or liability on the measurement date. The three levels are defined as follows:

 

Level 1—inputs to the valuation methodology are quoted prices (unadjusted) for an identical asset or liability in an active market.

 

Level 2—inputs to the valuation methodology include quoted prices for a similar asset or liability in an active market or model-derived valuations in which all significant inputs are observable for substantially the full term of the asset or liability.

 

Level 3—inputs to the valuation methodology are unobservable and significant to the fair value measurement of the asset or liability.

 

As of December 31, 2023 and March 31, 2023, the Company’s financial instruments included cash and cash equivalents, restricted cash, marketable securities, accounts payable, long-term debt, liability classified warrants and derivative liabilities. The carrying amounts reported in the accompanying unaudited condensed consolidated financial statements for cash and cash equivalents, restricted cash and marketable securities approximate their respective fair values because of the short-term nature of these accounts. The carrying value of the Company’s long-term debt approximates fair value based on current interest rates for similar types of borrowings and is in Level 3 of the fair value hierarchy. The liability classified warrants and derivative liabilities are each recorded at their fair value and are Level 3 of the fair value hierarchy.

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

The following table presents, for each of the fair value hierarchy levels required under ASC 820, the Company’s assets and liabilities that are measured at fair value on a recurring basis:

 

The fair value amounts as of December 31, 2023 are:

 

(in thousands)  Total   Level 1   Level 2   Level 3 
                 
Marketable securities :                    
Corporate debt securities  $-   $-   $-   $- 
Government securities   12,903    12,903    -    - 
Mutual funds   10,388    10,338    -    - 
Total assets measured and recorded at fair value  $23,292   $23,292   $-   $- 
                     
Liabilities :                    
Warrant liability  $192   $-   $-   $192 
Derivative liability   214    -    -    214 
Total liabilities measured and recorded at fair value  $406   $-   $-   $406 

 

The fair value amounts as of March 31, 2023 are:

 

(in thousands)  Total   Level 1   Level 2   Level 3 
                 
Marketable securities :                    
Corporate debt securities  $1,597   $1,597   $-   $- 
Government securities   1,013    1,013    -    - 
Mutual funds   14,114    14,114    -    - 
Total assets measured and recorded at fair value  $16,724   $16,724   $-   $- 
                     
Liabilities :                    
Warrant liability  $-   $-   $-   $- 
Derivative liability   -    -    -    - 
Total liabilities measured and recorded at fair value  $-   $-   $-   $- 

 

Level 3 Valuation

 

The common stock warrants issued in connection with the Loan and Security Agreement (as defined below) in June 2023 (Note 10) are recorded as a warrant liability within the unaudited condensed consolidated balance sheet as of December 31, 2023 as the warrants contain certain settlement features that are not indexed to the Company’s own stock. In addition, the conversion feature embedded within the long-term debt required bifurcation as certain adjustments to the conversion price were not indexed to the Company’s own stock and recorded as a derivative liability. The warrants and derivative liability are remeasured each reporting period with the change in fair value recorded to other income (expense) in the condensed consolidated statement of operations and comprehensive loss until the warrants and derivative are exercised, expired, reclassified or otherwise settled. The significant assumptions used in valuing the warrants and derivative were as follows:

 

   Warrants   Derivative 
Expected term (in years)   4.5    3.5 
Volatility   81%   81%
Risk-free rate   3.88%   3.97%

 

The table presented below is a summary of changes in the fair value of the Company’s Level 3 valuation for the warrants and derivatives for the nine months ended December 31, 2023 (in thousands):

 

   Warrants   Derivative 
Issuances  $885   $1,361 
Change in fair value   (693)   (1,147)
Balance at December 31, 2023  $192   $214 

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

Warrant Liability

Warrant Liability

 

The Company classifies warrants as equity any contracts that (i) require physical settlement or net-share settlement or (ii) gives the Company a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). The Company classifies warrants as assets or liabilities any contracts that (i) require net-cash settlement (including a requirement to net-cash settle the contract if an event occurs and if that event is outside the control of the Company) or (ii) gives the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). Such warrants are subject to remeasurement at each condensed consolidated balance sheet date and any change in fair value is recognized as a component of other expense on the condensed consolidated statements of operations and comprehensive loss. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of such warrants. At that time, the portion of the warrant liability related to warrants will be reclassified to additional paid-in capital.

 

Derivative Liability

Derivative Liability

 

The Company evaluates its financial instruments to determine if such instruments are derivatives or contain features that qualify as embedded derivatives in accordance with ASC 815, Derivatives and Hedging. For derivative financial instruments that are accounted for as assets or liabilities, the derivative instrument is initially recorded at its fair value on the grant date and is then re-valued at each reporting date, with changes in the fair value reported in the condensed consolidated statements of operations and comprehensive loss. The classification of derivative instruments, including whether such instruments should be recorded as assets or liabilities or as equity, is evaluated at the end of each reporting period. Derivative liabilities classified in the condensed consolidated balance sheets as current or non-current based on whether or not net-cash settlement or conversion of the instrument could be required within 12 months of the balance sheet date.

 

Cash and Cash Equivalents, Short-Term Investments and Restricted Cash

Cash and Cash Equivalents, Short-Term Investments and Restricted Cash

 

The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase and an investment in a U.S. government money market fund to be cash equivalents. The Company maintains its cash and cash equivalents in highly rated financial institutions in Australia, Israel, Ireland and the U.S., the balances of which, at times, may exceed federally insured limits. Marketable securities include investment in fixed income bonds and U.S. Treasury securities that are considered to be highly liquid and easily tradeable. The marketable securities are considered trading securities and are measured at fair value and are accounted for in accordance with ASC 320. The marketable securities are valued using inputs observable in active markets for identical securities and are therefore classified as Level 1 within the Company’s fair value hierarchy.

 

As of December 31, 2023 and March 31, 2023, restricted cash included approximately $0.2 million and $7.6 million, respectively. Restricted cash declined by $7.4 million from March 31, 2023 to December 31, 2023, as a $7.4 million supersedeas bond held as collateral pending the outcome of the appeal on Empery Asset Master, Ltd., et. al. vs. AIT Therapeutics, Inc. (the “Empery Suit”) was released in satisfaction of judgement in April 2023 (Note 10).

 

The following table is the reconciliation of the presentation and disclosure of cash, cash equivalents, marketable securities by major security type and restricted cash as shown on the Company’s condensed consolidated statements of cash flows for:

 

(in thousands) 

December 31,

2023

  

March 31,

2023

 
Cash and cash equivalents  $7,971   $29,158 
Restricted cash   231    7,610 
Total cash, cash equivalents and restricted cash  $8,202   $36,768 
Marketable securities:          
Marketable debt securities   -    - 
Corporate debt securities  $-   $1,597 
U.S. government securities   12,903    1,013 
Mutual fund (ultra-short-term income)   10,388    14,114 
Total marketable securities  $23,292   $16,724 
           
Total cash, cash equivalents, marketable securities and restricted cash  $31,494   $53,492 

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

The following table summarizes the Company’s short-term marketable securities with unrealized gains and losses as of December 31, 2023, aggregated by major security type:

 

(in thousands)  Fair Value  

Unrealized
Gains and

(Losses)

 
Corporate debt securities  $-   $- 
U.S. government securities   12,903    79 
Mutual fund (ultra-short-term income)   10,388    20 
Total short-term marketable securities  $23,292   $99 

 

The following table summarizes the Company’s short-term marketable securities with unrealized gains and losses as of March 31, 2023, aggregated by major security type:

 

(in thousands)  Fair Value  

Unrealized
Gains and

(Losses)

 
Corporate debt securities  $1,597   $2 
U.S. government securities   1,013    10 
Mutual fund (ultra-short-term income)   14,114    - 
Total short-term marketable securities  $16,724   $12 

 

All marketable securities are A- or higher rated. No marketable securities have maturities greater than 12 months. All investments are level 1 investments.

 

Revenue Recognition

Revenue Recognition

 

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

 

The Company will be required to use 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 the transaction price in step (iv) above. The Company will also be required to use judgment to determine whether variable consideration 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 contract are satisfied.

 

Segment Reporting

Segment Reporting

 

Commencing with the creation of Beyond Cancer in November 2021, the Company’s operations became classified into two segments, Beyond Air and Beyond Cancer. Each segment has its own management team, board of directors, corporate officers and legal entities. As of December 31, 2023, Beyond Air, Inc. owns 80% of the common stock of Beyond Cancer. The segment reporting is based on the manner in which the Company’s CEO as chief operating decision maker assesses performance and allocates resources across the organization. The Beyond Air segment includes unallocated corporate expenses associated with the public company fees as well as all corporate related assets and liabilities.

 

The following table summarizes segment financial information by business segment as of December 31, 2023:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Cash, cash equivalents, marketable securities and restricted cash  $18,081   $13,413   $31,494 
All other assets   19,781    636    20,417 
Total assets  $37,862   $14,048   $51,911 
Total liabilities  $(27,596)  $(844)  $(28,440)
Net assets  $10,266   $13,205   $23,471 
Non-controlling interest  $-   $2,657   $2,657 

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

The following table summarizes segment financial information by business segment as of March 31, 2023:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Cash, cash equivalents, marketable securities and restricted cash  $32,998   $20,494   $53,492 
All other assets   14,700    557    15,257 
Total assets  $47,699   $21,051   $68,749 
Total liabilities  $(26,201)  $(520)  $(26,721)
Net assets  $21,498   $20,530   $42,028 
Non-controlling interest  $-   $4,113   $4,113 

 

The following table summarizes segment financial performance by business segment for the nine months ended December 31, 2023:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Revenue  $689   $-   $689 
Net loss for the nine months ended December 31, 2023  $(33,721)  $(16,018)  $(49,739)

 

The following table summarizes segment financial performance by business segment for the three months ended December 31, 2023:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Revenue  $391   $-   $391 
Net loss for the three months ended December 31, 2023  $(12,065)  $(5,193)  $(17,258)

 

The following table summarizes segment financial performance by business segment for the nine months ended December 31, 2022:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
             
Revenue  $-   $-   $- 
Net loss for the nine months ended December 31, 2022  $(25,246)  $(13,004)  $(38,250)

 

The following table summarizes segment financial performance by business segment for the three months ended December 31, 2022:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Revenue  $-   $-   $- 
Net loss for the three months ended December 31, 2022  $(8,543)  $(5,255)  $(13,798)

 

Research and Development

Research and Development

 

Research and development expenses are charged to the condensed consolidated statements of operations and comprehensive loss as incurred. Research and development expenses include salaries, benefits, stock-based compensation and costs incurred by outside laboratories, manufacturers, clinical research organizations, consultants, and accredited facilities in connection with preclinical studies and clinical trials. Research and development 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. In the three months ended December 31, 2023 and December 31, 2022, the Company received $0 and $0 thousand, respectively, in AU Tax Rebates. In the nine months ended December 31, 2023 and December 31, 2022, the Company received $0 and $182 thousand, respectively, in AU Tax Rebates.

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

Stock-Based Compensation

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 date fair value of the award. Fair value for restricted stock unit awards is valued using the closing price of the Company’s common stock on the date of grant. The 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, using the accelerated method with each tranche being expensed over its vesting period. The grant 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. Starting in 2023, Beyond Air solely used its own historical volatility as the input for expected volatility, but due to Beyond Cancer’s lack of marketability, the Company utilizes the implied volatility based on an aggregate of guideline companies for expected volatility. The Company uses the simplified method to estimate the expected term.

 

Supplier Concentration

Supplier Concentration

 

The Company relies on third-party suppliers to provide materials for its devices and consumables.

 

In the three months ended December 31, 2023, the Company purchased approximately 92% of its materials from two third-party vendors, with these vendors representing 87% and 5%, respectively. In the three months ended December 31, 2022, the Company purchased approximately 87% of its materials from two third-party vendors, with these vendors representing 76% and 11%, respectively.

 

In the nine months ended December 31, 2023, the Company purchased approximately 89% of its materials from two third-party vendors, with these vendors representing 80% and 9%, respectively. In the nine months ended December 31, 2022, the Company purchased approximately 78% of its materials from two third-party vendors, with these vendors representing 65% and 13%, respectively.

 

Recently Adopted Accounting Standards

Recently Adopted Accounting Standards

 

In August 2020, the FASB issued ASU 2020-06 (“ASU 2020-06”), Debt — Debt with Conversion and Other Options (“Subtopic 470-20”), to address the complexity associated with applying U.S.GAAP to certain financial instruments with characteristics of liabilities and equity, which the Company adopted on April 1, 2023. ASU 2020-06 eliminated the beneficial conversion (and cash conversion) accounting models in Subtopic 470-20 that require separate accounting for embedded conversion features, and simplified the settlement assessment to determine whether it qualifies for equity classification. In addition, the new guidance requires entities to use the if-converted method to calculate earnings per share for all convertible instruments and to include the effect of share settlement for instruments that may be settled in cash or shares. The Company adopted ASU 2020-06 using the modified retrospective approach and applied the guidance to all financial instruments that were outstanding as of the beginning of 2023. As the Company had not previously separated any financial instruments under the beneficial conversion or cash conversion accounting models, there was no cumulative effect adjustment to the opening balance of retained earnings as a result of adopting ASU 2020-06.

 

Recently Issued Accounting Standards not yet Adopted

 

In November 2023, the FASB issued ASU-2023-07, Improvements to Reportable Segment Disclosures (Topic 280), to improve reportable segment disclosures about significant segment expenses. The amendments in this update will require public entities to disclose significant segment expenses that are regularly provided to the Company’s Chief Executive Officer as the Company’s Chief Operating Decision Maker (CODM). This guidance is effective for fiscal years beginning after December 15, 2023, (fiscal 2025 for the Company), and interim periods with fiscal years beginning after December 15, 2024, with early adoption permitted and will be applied retrospectively to all prior periods presented in the financial statements. The Company is evaluating the impact of adopting this new accounting guidance on its Consolidated Financial Statements.

 

In December 2023, the FASB issued ASU 2023-09, Improvements to Tax Disclosures (Topic 740), to enhance the transparency and decision usefulness of income tax disclosures through changes to the rate reconciliation and income taxes paid information. This guidance is effective for fiscal years beginning after December 15, 2024 (fiscal 2026 for the Company), with early adoption permitted. The Company is evaluating the impact of adopting this new accounting guidance on its Consolidated Financial Statements.

v3.24.0.1
SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (Tables)
9 Months Ended
Dec. 31, 2023
Accounting Policies [Abstract]  
SCHEDULE OF FAIR VALUE ON A RECURRING BASIS

The following table presents, for each of the fair value hierarchy levels required under ASC 820, the Company’s assets and liabilities that are measured at fair value on a recurring basis:

 

The fair value amounts as of December 31, 2023 are:

 

(in thousands)  Total   Level 1   Level 2   Level 3 
                 
Marketable securities :                    
Corporate debt securities  $-   $-   $-   $- 
Government securities   12,903    12,903    -    - 
Mutual funds   10,388    10,338    -    - 
Total assets measured and recorded at fair value  $23,292   $23,292   $-   $- 
                     
Liabilities :                    
Warrant liability  $192   $-   $-   $192 
Derivative liability   214    -    -    214 
Total liabilities measured and recorded at fair value  $406   $-   $-   $406 

 

The fair value amounts as of March 31, 2023 are:

 

(in thousands)  Total   Level 1   Level 2   Level 3 
                 
Marketable securities :                    
Corporate debt securities  $1,597   $1,597   $-   $- 
Government securities   1,013    1,013    -    - 
Mutual funds   14,114    14,114    -    - 
Total assets measured and recorded at fair value  $16,724   $16,724   $-   $- 
                     
Liabilities :                    
Warrant liability  $-   $-   $-   $- 
Derivative liability   -    -    -    - 
Total liabilities measured and recorded at fair value  $-   $-   $-   $- 
SCHEDULE OF VALUING THE WARRANTS AND DERIVATIVES

 

   Warrants   Derivative 
Expected term (in years)   4.5    3.5 
Volatility   81%   81%
Risk-free rate   3.88%   3.97%
SCHEDULE OF CHANGES IN FAIR VALUE OF WARRANTS AND DERIVATIVES

The table presented below is a summary of changes in the fair value of the Company’s Level 3 valuation for the warrants and derivatives for the nine months ended December 31, 2023 (in thousands):

 

   Warrants   Derivative 
Issuances  $885   $1,361 
Change in fair value   (693)   (1,147)
Balance at December 31, 2023  $192   $214 
SCHEDULE OF CASH AND CASH EQUIVALENTS AND RESTRICTED CASH

The following table is the reconciliation of the presentation and disclosure of cash, cash equivalents, marketable securities by major security type and restricted cash as shown on the Company’s condensed consolidated statements of cash flows for:

 

(in thousands) 

December 31,

2023

  

March 31,

2023

 
Cash and cash equivalents  $7,971   $29,158 
Restricted cash   231    7,610 
Total cash, cash equivalents and restricted cash  $8,202   $36,768 
Marketable securities:          
Marketable debt securities   -    - 
Corporate debt securities  $-   $1,597 
U.S. government securities   12,903    1,013 
Mutual fund (ultra-short-term income)   10,388    14,114 
Total marketable securities  $23,292   $16,724 
           
Total cash, cash equivalents, marketable securities and restricted cash  $31,494   $53,492 
SUMMARY OF SHORT-TERM MARKETABLE SECURITIES WITH UNREALIZED GAINS AND LOSSES

The following table summarizes the Company’s short-term marketable securities with unrealized gains and losses as of December 31, 2023, aggregated by major security type:

 

(in thousands)  Fair Value  

Unrealized
Gains and

(Losses)

 
Corporate debt securities  $-   $- 
U.S. government securities   12,903    79 
Mutual fund (ultra-short-term income)   10,388    20 
Total short-term marketable securities  $23,292   $99 

 

The following table summarizes the Company’s short-term marketable securities with unrealized gains and losses as of March 31, 2023, aggregated by major security type:

 

(in thousands)  Fair Value  

Unrealized
Gains and

(Losses)

 
Corporate debt securities  $1,597   $2 
U.S. government securities   1,013    10 
Mutual fund (ultra-short-term income)   14,114    - 
Total short-term marketable securities  $16,724   $12 

SCHEDULE OF SEGMENT FINANCIAL INFORMATION BY BUSINESS SEGMENT

The following table summarizes segment financial information by business segment as of December 31, 2023:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Cash, cash equivalents, marketable securities and restricted cash  $18,081   $13,413   $31,494 
All other assets   19,781    636    20,417 
Total assets  $37,862   $14,048   $51,911 
Total liabilities  $(27,596)  $(844)  $(28,440)
Net assets  $10,266   $13,205   $23,471 
Non-controlling interest  $-   $2,657   $2,657 

 

 

BEYOND AIR, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

 

NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)

 

The following table summarizes segment financial information by business segment as of March 31, 2023:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Cash, cash equivalents, marketable securities and restricted cash  $32,998   $20,494   $53,492 
All other assets   14,700    557    15,257 
Total assets  $47,699   $21,051   $68,749 
Total liabilities  $(26,201)  $(520)  $(26,721)
Net assets  $21,498   $20,530   $42,028 
Non-controlling interest  $-   $4,113   $4,113 

 

The following table summarizes segment financial performance by business segment for the nine months ended December 31, 2023:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Revenue  $689   $-   $689 
Net loss for the nine months ended December 31, 2023  $(33,721)  $(16,018)  $(49,739)

 

The following table summarizes segment financial performance by business segment for the three months ended December 31, 2023:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Revenue  $391   $-   $391 
Net loss for the three months ended December 31, 2023  $(12,065)  $(5,193)  $(17,258)

 

The following table summarizes segment financial performance by business segment for the nine months ended December 31, 2022:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
             
Revenue  $-   $-   $- 
Net loss for the nine months ended December 31, 2022  $(25,246)  $(13,004)  $(38,250)

 

The following table summarizes segment financial performance by business segment for the three months ended December 31, 2022:

 

(in thousands)  Beyond Air   Beyond Cancer   Total 
Revenue  $-   $-   $- 
Net loss for the three months ended December 31, 2022  $(8,543)  $(5,255)  $(13,798)
v3.24.0.1
PROPERTY AND EQUIPMENT (Tables)
9 Months Ended
Dec. 31, 2023
Property, Plant and Equipment [Abstract]  
SCHEDULE OF PROPERTY AND EQUIPMENT

Property and equipment consist of the following:

 

(in thousands) 

December 31,

2023

   March 31,
2023
 
         
Clinical and medical equipment  $2,041   $1,365 
Equipment deployable as part of a service offering   6,938    3,027 
Computer equipment   869    779 
Furniture and fixtures   532    505 
Leasehold improvements   617    581 
Property and equipment, gross   10,997    6,256 
Accumulated depreciation   (2,446)   (1,254)
Property and equipment, net  $8,551   $5,003 
v3.24.0.1
STOCKHOLDERS’ EQUITY (Tables)
9 Months Ended
Dec. 31, 2023
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
SCHEDULE OF RESTRICTED STOCK AWARDS

A summary of the Company’s restricted stock unit awards for the quarterly period ended December 31, 2023 is as follows:

 

  

Number Of

Shares

  

Weighted

Average Grant

Date Fair

Value

 
         
Unvested as of April 1, 2023   1,101,100   $6.78 
Granted   1,000    5.65 
Vested   (346,900)   6.49 
Forfeited   (6,800)   5.06 
Unvested as of December 31, 2023   748,400   $6.92 
SCHEDULE OF FAIR VALUE OF OPTION

The following was utilized to calculate the fair value of options on the date of grant:

 

   December 31,
2023
   December 31,
2022
 
Risk-free interest rate   4.34.9%   2.54.3%
Expected volatility (Beyond Air)   81.481.7%   87.4 - 89.2%
Expected volatility (Beyond Cancer)   104.3106.2 %   104.7-109.1%
Dividend yield   0%   0%
Expected terms (in years)   6.25    6.25 
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE

The following summarizes the components of stock-based compensation expense which included stock options and restricted stock units for the three and nine months ended December 31, 2023 and December 31, 2022:

 

(in thousands)  2023   2022   2023   2022 
   Three Months Ended   Nine Months Ended 
   December 31,   December 31, 
(in thousands)  2023   2022   2023   2022 
Research and development  $1,428   $1,290   $4,013   $3,247 
General and administrative   5,007    4,576    14,997    11,957 
Total stock-based compensation expense  $6,435   $5,866   $19,010   $15,204 
SUMMARY OF COMPANY’S OUTSTANDING WARRANTS

A summary of the Company’s outstanding warrants as of December 31, 2023 is as follows:

 

Warrant Holders 

Number of

Warrants

  

Exercise

Price

  

Intrinsic Value

(in thousands)

  

Date of

Expiration

 
                 
Third-party license agreement   208,333   $4.80   $       -    January 2024 
March 2020 loan   172,187   $7.26    -    March 2025 
NitricGen agreement   80,000   $6.90    -    January 2028 
Avenue agreement   233,843   $5.88    -    June 2028 
Total   694,363   $6.02   $-      
2013 Beyond Air Equity Incentive Plan [Member]  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
SCHEDULE OF STOCK OPTION ACTIVITY

A summary of the change in options for the nine months ended December 31, 2023,is as follows:

 

  

Number of

Options

  

Weighted

Average

Exercise

Price of

Options

  

Weighted

Average

Remaining

Contractual

Life of

Options

  

Aggregate

Intrinsic

Value

(in thousands)

 
                 
Options outstanding as of April 1, 2023   8,198,881   $5.83    8.4   $8,306 
Granted   132,500    3.95    -    - 
Exercised   (42,500)   5.10    -    - 
Forfeited   (310,787)   5.87    -    - 
Outstanding as of December 31, 2023   7,978,094   $5.82    7.4   $- 
Exercisable as of December 31, 2023   4,765,344   $5.46    6.4   $- 
2021 Beyond Cancer Ltd Equity Incentive Plan [Member]  
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]  
SCHEDULE OF STOCK OPTION ACTIVITY

 

  

Number of

Options

  

Weighted

Average

Exercise

Price of

Options

  

Weighted

Average

Remaining

Contractual

Life of

Options

  

Aggregate

Intrinsic

Value

(thousands)

 
                 
Options outstanding as of April 1, 2023   3,817,000   $2.88    9.2   $23,486 
Granted   155,000    5.50    -    - 
Exercised   -    -    -    - 
Forfeited   (142,500)   5.33    -    - 
Outstanding as of December 31, 2023   3,829,500   $5.50    8.5   $- 
Exercisable as of December 31, 2023   1,349,250   $5.50    8.3   $- 
v3.24.0.1
OTHER CURRENT ASSETS AND PREPAID EXPENSES (Tables)
9 Months Ended
Dec. 31, 2023
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract]  
SCHEDULE OF CURRENT ASSETS AND PREPAID EXPENSES

A summary of current assets and prepaid expenses as of December 31, 2023 and March 31, 2023 is as follows (in thousands):

 

  

December 31,

2023

  

March 31,

2023

 
Research and development  $119   $128 
Insurance   216    908 
Prepaid rents and tenant improvement   49    - 
Prepaid marketing materials   90    - 
Value added tax receivable   240    231 
Demonstration materials   211    245 
Deposits to secure manufacturing materials   5,019    2,519 
Other   174    337 
Total  $6,118   $4,369 
v3.24.0.1
ACCRUED EXPENSES (Tables)
9 Months Ended
Dec. 31, 2023
Payables and Accruals [Abstract]  
SUMMARY OF ACCRUED EXPENSES

A summary of the accrued expenses as of December 31, 2023 and March 31, 2023 is as follows (in thousands):

 

  

December 31,

2023

  

March 31,

2023

 
Research and development  $746   $426 
Professional fees   619    1,221 
Employee salaries and benefits   1,247    985 
Contingent litigation and settlements (Note 10)   400    10,298 
Circassia settlement – current portion (Note 8)   4,500    3,500 
Goods received not invoiced   85    - 
Other   285    184 
Total short-term accrued expenses  $7,882   $16,613 
           
Circassia settlement – long-term portion (Note 8)  $-   $4,500 
Total other long-term liabilities  $-   $4,500 
v3.24.0.1
BASIC AND DILUTED NET INCOME (LOSS) PER SHARE OF COMMON STOCK (Tables)
9 Months Ended
Dec. 31, 2023
Earnings Per Share [Abstract]  
SCHEDULE OF POTENTIAL ANTI-DILUTIVE SECURITIES

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

 

  

December 31,

2023

  

December 31,

2022

 
         
Common stock warrants   694,363    460,520 
Common stock options   7,978,094    5,645,131 
Restricted shares   748,400    769,500 
Loan and Security – conversion feature (Note 10)   392,465    - 
Total   9,813,322    6,875,151 
v3.24.0.1
COMMITMENTS AND CONTINGENCIES (Tables)
9 Months Ended
Dec. 31, 2023
Commitments and Contingencies Disclosure [Abstract]  
SCHEDULE OF MATURITY OF LONG TERM LOAN

The Company received $15.8 million in net proceeds on June 15, 2023 after all fees and advanced interest had been deducted.

 

Maturity of Long-Term Loan (in thousands)  December 31, 2023 
     
2025  $1,750 
2026   7,000 
2027   7,000 
2028   1,750 
Total  $17,500 
SCHEDULE OF LOAN AND SECURITY AGREEMENT

Components of Loan and Security Agreement

 

  

December 31,

2023

  

June 15,

2023 (Closing)

 
         
Amount outstanding  $17,500   $17,500 
Debt discount   (4,541)   (4,541)
Amortization of debt discount   779    - 
Final payment liability   613    613 
Total  $14,351   $13,572 
v3.24.0.1
ORGANIZATION AND BUSINESS (Details Narrative)
Nov. 04, 2021
Beyond Cancer Ltd [Member]  
Ownership percentage 80.00%
v3.24.0.1
SCHEDULE OF FAIR VALUE ON A RECURRING BASIS (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Mar. 31, 2023
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Total assets measured and recorded at fair value $ 23,292 $ 16,724
Warrant liability 192
Derivative liability 214  
Total liabilities measured and recorded at fair value 406
Fair Value, Inputs, Level 1 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Total assets measured and recorded at fair value 23,292 16,724
Total liabilities measured and recorded at fair value
Fair Value, Inputs, Level 2 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Total assets measured and recorded at fair value
Total liabilities measured and recorded at fair value
Fair Value, Inputs, Level 3 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Total assets measured and recorded at fair value
Total liabilities measured and recorded at fair value 406
Corporate Debt Securities [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Total assets measured and recorded at fair value 1,597
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Total assets measured and recorded at fair value 1,597
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Total assets measured and recorded at fair value
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Total assets measured and recorded at fair value
US Government Agencies Debt Securities [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Total assets measured and recorded at fair value 12,903 1,013
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Total assets measured and recorded at fair value 12,903 1,013
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Total assets measured and recorded at fair value
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Total assets measured and recorded at fair value
Mutual Funds [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Total assets measured and recorded at fair value 10,388 14,114
Mutual Funds [Member] | Fair Value, Inputs, Level 1 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Total assets measured and recorded at fair value 10,338 14,114
Mutual Funds [Member] | Fair Value, Inputs, Level 2 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Total assets measured and recorded at fair value
Mutual Funds [Member] | Fair Value, Inputs, Level 3 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Total assets measured and recorded at fair value
Warrant Liability [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Warrant liability 192
Warrant Liability [Member] | Fair Value, Inputs, Level 1 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Warrant liability
Warrant Liability [Member] | Fair Value, Inputs, Level 2 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Warrant liability
Warrant Liability [Member] | Fair Value, Inputs, Level 3 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Warrant liability 192
Derivative Liability [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Derivative liability 214
Derivative Liability [Member] | Fair Value, Inputs, Level 1 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Derivative liability
Derivative Liability [Member] | Fair Value, Inputs, Level 2 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Derivative liability
Derivative Liability [Member] | Fair Value, Inputs, Level 3 [Member]    
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Derivative liability $ 214
v3.24.0.1
SCHEDULE OF VALUING THE WARRANTS AND DERIVATIVES (Details)
9 Months Ended
Dec. 31, 2023
Measurement Input, Expected Term [Member]  
Fair Value Measurement Inputs and Valuation Techniques [Line Items]  
Expected term warrants 4 years 6 months
Expected term derivatives 3 years 6 months
Measurement Input, Price Volatility [Member]  
Fair Value Measurement Inputs and Valuation Techniques [Line Items]  
Warrants risk free rate 0.81
Derivative risk free rate 0.81
Measurement Input, Risk Free Interest Rate [Member]  
Fair Value Measurement Inputs and Valuation Techniques [Line Items]  
Warrants risk free rate 3.88
Derivative risk free rate 3.97
v3.24.0.1
SCHEDULE OF CHANGES IN FAIR VALUE OF WARRANTS AND DERIVATIVES (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2023
Dec. 31, 2022
Mar. 31, 2023
Accounting Policies [Abstract]          
Warrants issuance     $ 885    
Derivative issuance     1,361    
Change in fair value of warrants $ (46) (693)  
Change in fair value of derivatives (135) (1,147)  
Warrants 192   192  
Derivative $ 214   $ 214    
v3.24.0.1
SCHEDULE OF CASH AND CASH EQUIVALENTS AND RESTRICTED CASH (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Mar. 31, 2023
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]    
Cash and cash equivalents $ 7,971 $ 29,158
Restricted cash 231 7,610
Total cash, cash equivalents and restricted cash 8,202 36,768
Marketable securities:    
Total marketable securities 23,292 16,724
Total cash, cash equivalents, marketable securities and restricted cash 31,494 53,492
Marketable Debt Securities [Member]    
Marketable securities:    
Total marketable securities
Corporate Debt Securities [Member]    
Marketable securities:    
Total marketable securities 1,597
US Government Agencies Debt Securities [Member]    
Marketable securities:    
Total marketable securities 12,903 1,013
Mutual Fund [Member]    
Marketable securities:    
Total marketable securities $ 10,388 $ 14,114
v3.24.0.1
SUMMARY OF SHORT-TERM MARKETABLE SECURITIES WITH UNREALIZED GAINS AND LOSSES (Details) - USD ($)
$ in Thousands
9 Months Ended 12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Mar. 31, 2023
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]      
Marketable securities $ 23,292   $ 16,724
Total short-term marketable securities, Unrealized gains and (losses) (99) $ 38  
Short-Term Debt [Member]      
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]      
Marketable securities 23,292   16,724
Total short-term marketable securities, Unrealized gains and (losses) 99   12
Corporate Debt Securities [Member]      
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]      
Marketable securities   1,597
Corporate Debt Securities [Member] | Short-Term Debt [Member]      
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]      
Marketable securities   1,597
Total short-term marketable securities, Unrealized gains and (losses)   2
US Government Agencies Debt Securities [Member]      
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]      
Marketable securities 12,903   1,013
US Government Agencies Debt Securities [Member] | Short-Term Debt [Member]      
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]      
Marketable securities 12,903   1,013
Total short-term marketable securities, Unrealized gains and (losses) 79   10
Mutual Fund [Member]      
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]      
Marketable securities 10,388   14,114
Mutual Fund [Member] | Short-Term Debt [Member]      
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items]      
Marketable securities 10,388   14,114
Total short-term marketable securities, Unrealized gains and (losses) $ 20  
v3.24.0.1
SCHEDULE OF SEGMENT FINANCIAL INFORMATION BY BUSINESS SEGMENT (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2023
Dec. 31, 2022
Mar. 31, 2023
Cash, cash equivalents, marketable securities and restricted cash $ 31,494   $ 31,494   $ 53,492
Total assets 51,911   51,911   68,749
Total liabilities (28,440)   (28,440)   (26,721)
Non-controlling interest 2,657   2,657   4,113
Net loss for the three months ended December 31, 2022 (16,220) $ (12,747) (46,535) $ (35,649)  
Business Segment [Member]          
Cash, cash equivalents, marketable securities and restricted cash 31,494   31,494   53,492
All other assets 20,417   20,417   15,257
Total assets 51,911   51,911   68,749
Total liabilities (28,440)   (28,440)   (26,721)
Net assets 23,471   23,471   42,028
Non-controlling interest 2,657   2,657   4,113
Revenue 391 689  
Net loss for the three months ended December 31, 2022 (17,258) (13,798) (49,739) (38,250)  
Business Segment [Member] | Beyond Air [Member]          
Cash, cash equivalents, marketable securities and restricted cash 18,081   18,081   32,998
All other assets 19,781   19,781   14,700
Total assets 37,862   37,862   47,699
Total liabilities (27,596)   (27,596)   (26,201)
Net assets 10,266   10,266   21,498
Non-controlling interest    
Revenue 391 689  
Net loss for the three months ended December 31, 2022 (12,065) (8,543) (33,721) (25,246)  
Business Segment [Member] | Beyond Cancer [Member]          
Cash, cash equivalents, marketable securities and restricted cash 13,413   13,413   20,494
All other assets 636   636   557
Total assets 14,048   14,048   21,051
Total liabilities (844)   (844)   (520)
Net assets 13,205   13,205   20,530
Non-controlling interest 2,657   2,657   $ 4,113
Revenue  
Net loss for the three months ended December 31, 2022 $ (5,193) $ (5,255) $ (16,018) $ (13,004)  
v3.24.0.1
SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended 9 Months Ended
Feb. 04, 2022
Jan. 31, 2023
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2023
Dec. 31, 2022
Mar. 31, 2023
Product Information [Line Items]              
Net cash used in operating activities         $ 45,289,000 $ 24,569,000  
Accumulated deficit     $ 225,990,000   225,990,000   $ 179,455,000
Cash equivalents     31,300,000   31,300,000    
Cash deposit     5,200,000   5,200,000    
Restricted cash declined         7,400,000    
Marketable securities non-current     $ 0   $ 0    
Accounts Payable [Member] | Supplier Concentration Risk [Member] | Two Third-party Vendors [Member]              
Product Information [Line Items]              
Concentration risk percentage     92.00% 87.00% 89.00% 78.00%  
Accounts Payable [Member] | Supplier Concentration Risk [Member] | Third-Party Vendor One [Member]              
Product Information [Line Items]              
Concentration risk percentage     87.00% 76.00% 80.00% 65.00%  
Accounts Payable [Member] | Supplier Concentration Risk [Member] | Third-Party Vendor Two [Member]              
Product Information [Line Items]              
Concentration risk percentage     5.00% 11.00% 9.00% 13.00%  
Australian Taxation Office [Member]              
Product Information [Line Items]              
Tax Rebate     $ 0 $ 182,000  
Empery Asset Master Ltd [Member]              
Product Information [Line Items]              
Restricted cash declined         7,400,000    
Contract Manufacturer [Member]              
Product Information [Line Items]              
Restricted cash     200,000   200,000   $ 7,600,000
Maximum [Member]              
Product Information [Line Items]              
Proceeds from issuance or sale of equity   $ 200,000,000          
At-The-Market Equity Offering Sales Agreement [Member]              
Product Information [Line Items]              
Proceeds from issuance or sale of equity $ 50,000,000.0       34,300,000    
Loan and Security Agreement [Member] | Avenue Capital Management I I L P [Member]              
Product Information [Line Items]              
Line of credit     $ 22,500,000   $ 22,500,000    
Beyond Cancer Ltd [Member]              
Product Information [Line Items]              
Non-controlling owners interest     20.00%   20.00%    
v3.24.0.1
SCHEDULE OF PROPERTY AND EQUIPMENT (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Mar. 31, 2023
Property, Plant and Equipment [Line Items]    
Property and equipment, gross $ 10,997 $ 6,256
Accumulated depreciation (2,446) (1,254)
Property and equipment, net 8,551 5,003
Clinical and Medical Equipment [Member]    
Property, Plant and Equipment [Line Items]    
Property and equipment, gross 2,041 1,365
Equipment Deployable as Part of Service Offering [Member]    
Property, Plant and Equipment [Line Items]    
Property and equipment, gross 6,938 3,027
Computer Equipment [Member]    
Property, Plant and Equipment [Line Items]    
Property and equipment, gross 869 779
Furniture and Fixtures [Member]    
Property, Plant and Equipment [Line Items]    
Property and equipment, gross 532 505
Leasehold Improvements [Member]    
Property, Plant and Equipment [Line Items]    
Property and equipment, gross $ 617 $ 581
v3.24.0.1
PROPERTY AND EQUIPMENT (Details Narrative) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended 12 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2022
Property, Plant and Equipment [Line Items]          
Depreciation and amortization $ 500 $ 200 $ 1,185 $ 439  
Research and Development expense $ 6,838 5,000 $ 18,664 12,679  
Research and Development Expense [Member]          
Property, Plant and Equipment [Line Items]          
Accumulated depreciation   100   100 $ 100
Clinical and Medical Equipment [Member]          
Property, Plant and Equipment [Line Items]          
Accumulated depreciation   $ 400   $ 400 400
Research and Development expense         $ 200
v3.24.0.1
SCHEDULE OF RESTRICTED STOCK AWARDS (Details) - $ / shares
3 Months Ended 9 Months Ended
Dec. 31, 2023
Dec. 31, 2023
Equity [Abstract]    
Unvested number of shares, beginning balance   1,101,100
Weighted average grant date fair value, beginning balance   $ 6.78
Number of shares, granted   1,000
Weighted average grant date fair value, granted   $ 5.65
Number of shares, vested (346,900) (346,900)
Weighted average grant date fair value, vested   $ 6.49
Number of shares, forfeited   (6,800)
Unvested number of shares, ending balance 748,400 748,400
Weighted average grant date fair value, ending balance $ 6.92 $ 6.92
v3.24.0.1
SCHEDULE OF STOCK OPTION ACTIVITY (Details) - USD ($)
$ / shares in Units, $ in Thousands
9 Months Ended 12 Months Ended
Dec. 31, 2023
Mar. 31, 2023
2013 Beyond Air Equity Incentive Plan [Member]    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Number of Options, Outstanding at beginning of period 8,198,881  
Weighted Average Exercise Price - Options, Outstanding at beginning of period $ 5.83  
Weighted average remaining contractual life - options, outstanding at end of period 7 years 4 months 24 days 8 years 4 months 24 days
Aggregate Intrinsic Value, Outstanding at beginning of period $ 8,306  
Number of Options Outstanding, Granted 132,500  
Weighted Average Exercise Price - Options, Granted $ 3.95  
Number of Options Outstanding, Exercised (42,500)  
Weighted Average Exercise Price - Options, Exercised $ 5.10  
Number of Options Outstanding, Forfeited (310,787)  
Weighted Average Exercise Price - Options, Forfeited $ 5.87  
Number of options outstanding at ending of period 7,978,094 8,198,881
Weighted Average Exercise Price - Options, Outstanding at ending of period $ 5.82 $ 5.83
Aggregate Intrinsic Value, Outstanding at end of period $ 8,306
Number of Options Outstanding, Exercisable 4,765,344  
Weighted Average Exercise Price - Options, Exercisable $ 5.46  
Weighted average remaining contractual life - options, exercisable 6 years 4 months 24 days  
Aggregate Intrinsic Value, Exercisable  
2021 Beyond Cancer Ltd Equity Incentive Plan [Member]    
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items]    
Number of Options, Outstanding at beginning of period 3,817,000  
Weighted Average Exercise Price - Options, Outstanding at beginning of period $ 2.88  
Weighted average remaining contractual life - options, outstanding at end of period 8 years 6 months 9 years 2 months 12 days
Aggregate Intrinsic Value, Outstanding at beginning of period $ 23,486  
Number of Options Outstanding, Granted 155,000  
Weighted Average Exercise Price - Options, Granted $ 5.50  
Number of Options Outstanding, Exercised  
Weighted Average Exercise Price - Options, Exercised  
Number of Options Outstanding, Forfeited (142,500)  
Weighted Average Exercise Price - Options, Forfeited $ 5.33  
Number of options outstanding at ending of period 3,829,500 3,817,000
Weighted Average Exercise Price - Options, Outstanding at ending of period $ 5.50 $ 2.88
Aggregate Intrinsic Value, Outstanding at end of period $ 23,486
Number of Options Outstanding, Exercisable 1,349,250  
Weighted Average Exercise Price - Options, Exercisable $ 5.50  
Weighted average remaining contractual life - options, exercisable 8 years 3 months 18 days  
Aggregate Intrinsic Value, Exercisable  
v3.24.0.1
SCHEDULE OF FAIR VALUE OF OPTION (Details)
9 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dividend yield 0.00% 0.00%
Expected term (in years) 6 years 3 months 6 years 3 months
Minimum [Member]    
Risk-free interest rate 4.30% 2.50%
Minimum [Member] | Beyond Air [Member]    
Expected volatility 81.40% 87.40%
Minimum [Member] | Beyond Cancer Ltd [Member]    
Expected volatility 104.30% 104.70%
Maximum [Member]    
Risk-free interest rate 4.90% 4.30%
Maximum [Member] | Beyond Air [Member]    
Expected volatility 81.70% 89.20%
Maximum [Member] | Beyond Cancer Ltd [Member]    
Expected volatility 106.20% 109.10%
v3.24.0.1
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE (Details) - USD ($)
$ in Thousands
3 Months Ended 9 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Dec. 31, 2023
Dec. 31, 2022
Total stock-based compensation expense $ 6,435 $ 5,866 $ 19,010 $ 15,204
Research and Development Expense [Member]        
Total stock-based compensation expense 1,428 1,290 4,013 3,247
General and Administrative Expense [Member]        
Total stock-based compensation expense $ 5,007 $ 4,576 $ 14,997 $ 11,957
v3.24.0.1
SUMMARY OF COMPANY’S OUTSTANDING WARRANTS (Details) - USD ($)
9 Months Ended
Dec. 31, 2023
Jun. 15, 2023
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Number of Warrants 694,363 233,843
Exercise Price $ 6.02 $ 5.88
Intrinsic Value  
Third Party License Agreement [Member]    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Number of Warrants 208,333  
Exercise Price $ 4.80  
Intrinsic Value  
Date of Expiration January 2024  
March 2020 loan [Member]    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Number of Warrants 172,187  
Exercise Price $ 7.26  
Intrinsic Value  
Date of Expiration March 2025  
NitricGen Agreement [Member]    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Number of Warrants 80,000  
Exercise Price $ 6.90  
Intrinsic Value  
Date of Expiration January 2028  
Avenue Capital [Member]    
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]    
Number of Warrants 233,843  
Exercise Price $ 5.88  
Intrinsic Value  
Date of Expiration June 2028  
v3.24.0.1
STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($)
$ / shares in Units, $ in Thousands
3 Months Ended 9 Months Ended
Feb. 04, 2022
Dec. 31, 2023
Jun. 30, 2023
Dec. 31, 2022
Sep. 30, 2022
Jun. 30, 2022
Dec. 31, 2023
Dec. 31, 2022
Sep. 07, 2023
Mar. 31, 2023
Nov. 03, 2022
Dec. 01, 2021
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Net proceeds from sale of commom stock             $ 11,973 $ 214        
Proceeds from common stock     $ 217   $ 200          
Exercise of stock options             42,500          
Restricted stock units, vested   346,900         346,900          
Shares authorized for issuance   100,000,000         100,000,000     100,000,000    
Employee benefits and share based compensation   $ 700   $ 600     $ 2,200 $ 2,000        
Unrecognized stock-based compensation expense   $ 2,800         $ 2,800          
Weighted average remaining service period             2 years          
Warrant [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Number of warrants exercised                      
Beyond Air Equity Incentive Plan [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Stock options excercised   3,000,000         3,000,000          
Two Thousand Thirteen BA Plan [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Shares authorized for issuance   10,600,000         10,600,000          
Common stock shares available   567,308         567,308          
2021 Beyond Cancer Ltd Equity Incentive Plan [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Stock options excercised   1,349,250         1,349,250          
Unrecognized stock-based compensation expense   $ 11,200         $ 11,200          
Weighted average remaining service period             1 year 2 months 19 days          
Stock option vesting term, description             The vesting terms of the options issued under the 2021 BC Plan are generally four years and expire ten years from the grant date.          
Stock option vesting term             10 years          
Stock option shares authorized for issuance   4,000,000         4,000,000       2,000,000 2,000,000
Number of shares available for grant   170,500         170,500          
Weighted average exercise price options   $ 5.50         $ 5.50   $ 5.50 $ 2.88    
Share based compensation arrangements by share based payment award options grants in period weighted average exercise price             $ 5.50          
Number of warrants exercised                      
2013 BA Plan [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Unrecognized stock-based compensation expense   $ 8,800         $ 8,800          
Weighted average remaining service period             1 year 9 months 18 days          
2021 BC Plan [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Share based compensation arrangements by share based payment award options grants in period weighted average exercise price             $ 4.60          
2013 Beyond Air Equity Incentive Plan [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Stock options excercised   4,765,344         4,765,344          
Weighted average exercise price options   $ 5.82         $ 5.82     $ 5.83    
Share based compensation arrangements by share based payment award options grants in period weighted average exercise price             $ 3.95          
Number of warrants exercised             42,500          
2013 Beyond Air Equity Incentive Plan [Member] | Unvested Stock Options [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Share based compensation arrangements by share based payment award options grants in period weighted average exercise price               $ 8.35        
At-The-Market Equity Offering Sales Agreement [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Funds available under ATM $ 50,000           $ 34,300          
Fees paid percentage 3.00%                      
Net proceeds from sale of commom stock             $ 12,000          
Number of shares sold             4,350,138          
2020 ATM [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Number of shares sold               19,300        
Net proceeds from sale of commom stock               $ 200        
Avenue Capital [Member] | Warrant [Member]                        
Accumulated Other Comprehensive Income (Loss) [Line Items]                        
Number of warrants issued   233,843         233,843          
v3.24.0.1
SCHEDULE OF CURRENT ASSETS AND PREPAID EXPENSES (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Mar. 31, 2023
Total $ 6,118 $ 4,369
Research and Development Expense [Member]    
Total 119 128
Insurance [Member]    
Total 216 908
Prepaid Rents and Tenant Improvement [Member]    
Total 49
Prepaid Marketing Materials [Member]    
Total 90
Value Added Tax Receivable [Member]    
Total 240 231
Demonstration Materials [Member]    
Total 211 245
Other [Member]    
Total $ 5,019 $ 2,519
v3.24.0.1
SUMMARY OF ACCRUED EXPENSES (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Mar. 31, 2023
Payables and Accruals [Abstract]    
Research and development $ 746 $ 426
Professional fees 619 1,221
Employee salaries and benefits 1,247 985
Contingent litigation and settlements (Note 10) 400 10,298
Circassia settlement – current portion (Note 8) 4,500 3,500
Goods received not invoiced 85
Other 285 184
Total short-term accrued expenses 7,882 16,613
Circassia settlement – long-term portion (Note 8) 4,500
Total other long-term liabilities $ 4,500
v3.24.0.1
SCHEDULE OF POTENTIAL ANTI-DILUTIVE SECURITIES (Details) - shares
9 Months Ended
Dec. 31, 2023
Dec. 31, 2022
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 9,813,322 6,875,151
Loan and Security – conversion feature (Note 10) 392,465
Warrant [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 694,363 460,520
Equity Option [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 7,978,094 5,645,131
Restricted Stock [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Total 748,400 769,500
v3.24.0.1
LICENSE AGREEMENT (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended
May 25, 2021
May 25, 2021
Aug. 31, 2023
Jul. 31, 2022
Sep. 30, 2025
Dec. 31, 2023
Mar. 31, 2023
Loss Contingency Accrual, Payments       $ 2,500,000      
Accrued Liabilities           $ 4,500,000 $ 8,000,000.0
Settlement Agreement [Member]              
Litigation Settlement, Amount Awarded to Other Party     $ 3,500,000        
Royalty payment percentage 5.00%            
Settlement Agreement [Member] | Forecast [Member]              
Litigation Settlement, Amount Awarded to Other Party         $ 4,500,000    
Settlement Agreement [Member] | Cricassia Limited [Member]              
Payments for royalties   $ 6.0          
Three Installments [Member] | Settlement Agreement [Member]              
Litigation Settlement, Amount Awarded to Other Party $ 10,500,000            
First Payment [Member] | Settlement Agreement [Member]              
Litigation Settlement, Amount Awarded to Other Party 2,500,000            
First Anniversary [Member] | Settlement Agreement [Member]              
Litigation Settlement, Amount Awarded to Other Party 3,500,000            
Second Anniversary [Member] | Settlement Agreement [Member]              
Litigation Settlement, Amount Awarded to Other Party $ 4,500,000            
v3.24.0.1
GRANT COLLABORATION AGREEMENT (Details Narrative) - USD ($)
$ in Thousands
9 Months Ended
Feb. 10, 2021
Dec. 31, 2023
Mar. 31, 2023
Product Information [Line Items]      
Grants Receivable   $ 420
Cystic Fibrosis Foundation [Member]      
Product Information [Line Items]      
Grants Receivable $ 2,200    
Grants reduction expenses   1,700  
Payments for royalties   $ 1,700  
Cystic Fibrosis Foundation [Member] | Revenue Benchmark [Member] | Customer Concentration Risk [Member]      
Product Information [Line Items]      
Concentration risk percentage 10.00%    
v3.24.0.1
SCHEDULE OF MATURITY OF LONG TERM LOAN (Details) - USD ($)
$ in Thousands
Jun. 15, 2023
Dec. 31, 2023
Commitments and Contingencies Disclosure [Abstract]    
Interest, net proceeds $ 15,800  
2025   $ 1,750
2026   7,000
2027   7,000
2028   1,750
Total   $ 17,500
v3.24.0.1
SCHEDULE OF LOAN AND SECURITY AGREEMENT (Details) - USD ($)
$ in Thousands
Dec. 31, 2023
Jun. 15, 2023
Commitments and Contingencies Disclosure [Abstract]    
Amount outstanding $ 17,500 $ 17,500
Debt discount (4,541) (4,541)
Amortization of debt discount 779
Final payment liability 613 613
Total $ 14,351 $ 13,572
v3.24.0.1
COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($)
1 Months Ended 9 Months Ended
Dec. 31, 2023
Jun. 15, 2023
Apr. 12, 2023
Jan. 31, 2018
Jan. 13, 2017
Mar. 31, 2022
Dec. 31, 2023
Dec. 31, 2022
Mar. 31, 2023
Dec. 28, 2021
Loss Contingencies [Line Items]                    
Cash deposits $ 5,200,000           $ 5,200,000      
Loss Contingency, Damages Paid, Value     $ 7,600,000              
Accrued Liabilities $ 4,500,000           $ 4,500,000   $ 8,000,000.0  
Class of Warrant or Right, Outstanding 694,363 233,843         694,363      
Class of Warrant or Right, Exercise Price of Warrants or Rights $ 6.02 $ 5.88         $ 6.02      
Conversion of shares             392,465    
Loan and Security Agreement [Member]                    
Loss Contingencies [Line Items]                    
Loan, maturity date   Jun. 01, 2027                
Interest rate terms   (i) the prime rate, as published by the Wall Street Journal from time to time, plus 3.75% and (ii) 12.00%. The Company may, subject to certain parameters, voluntarily prepay the Loans, in whole or in part, at any time. If prepayment occurs on or before the one-year anniversary of the Closing Date, the Company is required to pay a fee equal to the principal amount of the Loans prepaid multiplied by 3.00%; if prepayment occurs after the one-year anniversary of the Closing Date and on or before the two-year anniversary of the Closing Date, the Company is required to pay a fee equal to the principal amount of the Loans prepaid multiplied by 2.00%; if prepayment occurs after the two-year anniversary and on or before the three-year anniversary of the Closing Date, the Company is required to pay a fee equal to the principal amount of the Loans prepaid multiplied by 1.50%; and if prepayment occurs after the three-year anniversary of the Closing Date and before the Maturity Date, the Company is required to pay a fee equal to the principal amount of the Loans prepaid multiplied by 1.00%.                
Debt interest rate, stated percentage   3.50%                
Unrestricted cash   $ 5.0                
Loan and Security Agreement [Member] | Tranche 1 [Member]                    
Loss Contingencies [Line Items]                    
Secured debt   $ 17,500,000                
Loan and Security Agreement [Member] | Tranche 2 [Member]                    
Loss Contingencies [Line Items]                    
Principal payment term   additional 6 to 18 months                
Revenues   $ 40,000,000.0                
Loan and Security Agreement [Member] | Maximum [Member]                    
Loss Contingencies [Line Items]                    
Secured debt   40,000,000.0                
Loan and Security Agreement [Member] | Maximum [Member] | Tranche 2 [Member]                    
Loss Contingencies [Line Items]                    
Secured debt   $ 10,000,000.0                
Product revenue percentage   85.00%                
Loan and Security Agreement [Member] | Maximum [Member] | Tranche 3 [Member]                    
Loss Contingencies [Line Items]                    
Secured debt   $ 12,500,000                
Hudson Bay Master Fund [Member]                    
Loss Contingencies [Line Items]                    
Loss Contingency Accrual $ 3,100,000           $ 3,100,000      
Accrued Liabilities 0           0   $ 2,700,000  
January 2017 Offering [Member] | Hudson Bay Master Fund [Member]                    
Loss Contingencies [Line Items]                    
Warrants to purchase common stock                   83,334
Supplier Concentration Risk [Member] | Supplier [Member]                    
Loss Contingencies [Line Items]                    
Outstanding amount under purchase 5,500,000           5,500,000      
Supplier Concentration Risk [Member] | Supplier [Member] | Cost of Goods and Service Benchmark [Member]                    
Loss Contingencies [Line Items]                    
Cash deposits 5,100,000           5,100,000      
Avenue Capital Group [Member]                    
Loss Contingencies [Line Items]                    
Conversion principal amount             $ 3,000,000.0      
Conversion stock price             130.00%      
Avenue Capital Group [Member] | Common Stock [Member]                    
Loss Contingencies [Line Items]                    
Conversion of shares             392,465      
Conversion amount             $ 7.644      
Option Agreement [Member]                    
Loss Contingencies [Line Items]                    
Payments for stock option exercised         $ 500,000          
Milestone payments         87,000,000          
Sales related milestones payments         $ 83,000,000          
NitricGen Agreement [Member]                    
Loss Contingencies [Line Items]                    
Milestone payments $ 300,000                  
Class of Warrant or Right, Outstanding 80,000           80,000      
Class of Warrant or Right, Exercise Price of Warrants or Rights $ 6.90           $ 6.90      
NitricGen Agreement [Member] | NitricGen, Inc [Member]                    
Loss Contingencies [Line Items]                    
Milestone payments       $ 2,000,000.0            
Future payments based on certain milestones       $ 100,000   $ 1,500,000        
Warrants to purchase common stock       100,000            
NitricGen Agreement [Member] | NitricGen, Inc [Member] | Next Milestones [Member]                    
Loss Contingencies [Line Items]                    
Future payments based on certain milestones       $ 100,000            

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