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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
PART
I FINANCIAL INFORMATION
ITEM
1. Financial Statements.
CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
INDEX
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.
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.
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 | |
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 | |
Balance | |
| 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 | ) |
Other comprehensive income (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 | |
Balance | |
| 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.
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 | |
| | | |
| | |
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.
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.
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.
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:
SCHEDULE OF FAIR VALUE ON A RECURRING BASIS
(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:
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 | % |
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):
SCHEDULE OF CHANGES IN FAIR VALUE OF WARRANTS AND DERIVATIVES
| |
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:
SCHEDULE OF CASH AND CASH EQUIVALENTS AND RESTRICTED CASH
(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:
SUMMARY OF SHORT-TERM MARKETABLE SECURITIES WITH UNREALIZED GAINS AND LOSSES
(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:
SCHEDULE OF SEGMENT FINANCIAL INFORMATION BY BUSINESS SEGMENT
(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.
NOTE
3 PROPERTY AND EQUIPMENT
Property
and equipment consist of the following:
SCHEDULE OF PROPERTY AND EQUIPMENT
(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)
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:
SCHEDULE OF RESTRICTED STOCK AWARDS
| |
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:
SCHEDULE OF STOCK OPTION ACTIVITY
| |
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.
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 | | |
$ | - | |
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:
SCHEDULE OF FAIR VALUE OF OPTION
| |
December 31,
2023 | | |
December 31,
2022 | |
Risk-free interest rate | |
| 4.3
– 4.9 | % | |
| 2.5
– 4.3 | % |
Expected volatility (Beyond Air) | |
| 81.4
– 81.7 | % | |
| 87.4
- 89.2 | % |
Expected volatility (Beyond Cancer) | |
| 104.3
– 106.2 | % | |
| 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:
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE
(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:
SUMMARY OF COMPANY’S OUTSTANDING WARRANTS
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)
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):
SCHEDULE OF CURRENT ASSETS AND PREPAID EXPENSES
| |
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):
SUMMARY OF ACCRUED EXPENSES
| |
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)
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:
SCHEDULE OF POTENTIAL ANTI-DILUTIVE SECURITIES
| |
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.
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.
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.
SCHEDULE OF MATURITY OF LONG TERM LOAN
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
SCHEDULE 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 | |
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.
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.
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.
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.
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.
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 |
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 | |
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.
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.
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.
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.
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.
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.
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) |
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.
v3.24.0.1
Cover - shares
|
9 Months Ended |
|
Dec. 31, 2023 |
Feb. 12, 2024 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Dec. 31, 2023
|
|
Document Fiscal Period Focus |
Q3
|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--03-31
|
|
Entity File Number |
001-38892
|
|
Entity Registrant Name |
BEYOND
AIR, INC.
|
|
Entity Central Index Key |
0001641631
|
|
Entity Tax Identification Number |
47-3812456
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
900
Stewart Avenue
|
|
Entity Address, Address Line Two |
Suite 301
|
|
Entity Address, City or Town |
Garden
City
|
|
Entity Address, State or Province |
NY
|
|
Entity Address, Postal Zip Code |
11530
|
|
City Area Code |
516
|
|
Local Phone Number |
665-8200
|
|
Title of 12(b) Security |
Common
Stock, par value $0.0001 per share
|
|
Trading Symbol |
XAIR
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
false
|
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Entity Shell Company |
false
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Entity Common Stock, Shares Outstanding |
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36,039,056
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v3.24.0.1
Condensed Consolidated Balance Sheets - USD ($) $ 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
|
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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
|
X |
- DefinitionFace amount or stated value per share of common stock.
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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
|
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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
|
|
|
|
|
|
|
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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
|
|
X |
- DefinitionChange in fair value of derivative liability.
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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)
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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:
SCHEDULE OF FAIR VALUE ON A RECURRING BASIS
(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:
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 | % |
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):
SCHEDULE OF CHANGES IN FAIR VALUE OF WARRANTS AND DERIVATIVES
| |
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:
SCHEDULE OF CASH AND CASH EQUIVALENTS AND RESTRICTED CASH
(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:
SUMMARY OF SHORT-TERM MARKETABLE SECURITIES WITH UNREALIZED GAINS AND LOSSES
(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:
SCHEDULE OF SEGMENT FINANCIAL INFORMATION BY BUSINESS SEGMENT
(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.
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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:
SCHEDULE OF PROPERTY AND EQUIPMENT
(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)
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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:
SCHEDULE OF RESTRICTED STOCK AWARDS
| |
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:
SCHEDULE OF STOCK OPTION ACTIVITY
| |
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.
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 | | |
$ | - | |
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:
SCHEDULE OF FAIR VALUE OF OPTION
| |
December 31,
2023 | | |
December 31,
2022 | |
Risk-free interest rate | |
| 4.3
– 4.9 | % | |
| 2.5
– 4.3 | % |
Expected volatility (Beyond Air) | |
| 81.4
– 81.7 | % | |
| 87.4
- 89.2 | % |
Expected volatility (Beyond Cancer) | |
| 104.3
– 106.2 | % | |
| 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:
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE
(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:
SUMMARY OF COMPANY’S OUTSTANDING WARRANTS
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)
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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):
SCHEDULE OF CURRENT ASSETS AND PREPAID EXPENSES
| |
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 | |
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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):
SUMMARY OF ACCRUED EXPENSES
| |
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)
|
X |
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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:
SCHEDULE OF POTENTIAL ANTI-DILUTIVE SECURITIES
| |
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 | |
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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.
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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)
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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.
SCHEDULE OF MATURITY OF LONG TERM LOAN
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
SCHEDULE 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 | |
|
X |
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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:
SCHEDULE OF FAIR VALUE ON A RECURRING BASIS
(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:
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 | % |
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):
SCHEDULE OF CHANGES IN FAIR VALUE OF WARRANTS AND DERIVATIVES
| |
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:
SCHEDULE OF CASH AND CASH EQUIVALENTS AND RESTRICTED CASH
(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:
SUMMARY OF SHORT-TERM MARKETABLE SECURITIES WITH UNREALIZED GAINS AND LOSSES
(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:
SCHEDULE OF SEGMENT FINANCIAL INFORMATION BY BUSINESS SEGMENT
(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.
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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:
SCHEDULE OF FAIR VALUE ON A RECURRING BASIS
(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 |
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):
SCHEDULE OF CHANGES IN FAIR VALUE OF WARRANTS AND DERIVATIVES
| |
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:
SCHEDULE OF CASH AND CASH EQUIVALENTS AND RESTRICTED CASH
(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:
SUMMARY OF SHORT-TERM MARKETABLE SECURITIES WITH UNREALIZED GAINS AND LOSSES
(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:
SCHEDULE OF SEGMENT FINANCIAL INFORMATION BY BUSINESS SEGMENT
(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 | ) |
|
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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:
SCHEDULE OF PROPERTY AND EQUIPMENT
(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 | |
|
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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:
SCHEDULE OF RESTRICTED STOCK AWARDS
| |
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:
SCHEDULE OF FAIR VALUE OF OPTION
| |
December 31,
2023 | | |
December 31,
2022 | |
Risk-free interest rate | |
| 4.3
– 4.9 | % | |
| 2.5
– 4.3 | % |
Expected volatility (Beyond Air) | |
| 81.4
– 81.7 | % | |
| 87.4
- 89.2 | % |
Expected volatility (Beyond Cancer) | |
| 104.3
– 106.2 | % | |
| 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:
SCHEDULE OF STOCK-BASED COMPENSATION EXPENSE
(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:
SUMMARY OF COMPANY’S OUTSTANDING WARRANTS
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:
SCHEDULE OF STOCK OPTION ACTIVITY
| |
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 |
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 | | |
$ | - | |
|
X |
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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):
SCHEDULE OF CURRENT ASSETS AND PREPAID EXPENSES
| |
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 | |
|
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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):
SUMMARY OF ACCRUED EXPENSES
| |
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 | |
|
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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:
SCHEDULE OF POTENTIAL ANTI-DILUTIVE SECURITIES
| |
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 | |
|
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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.
SCHEDULE OF MATURITY OF LONG TERM LOAN
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
SCHEDULE 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 | |
|
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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
|
|
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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
|
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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
|
|
|
X |
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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)
|
|
X |
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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%
|
|
|
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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] |
|
|
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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
|
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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
|
X |
- DefinitionThe current period expense charged against earnings on long-lived, physical assets not used in production, and which are not intended for resale, to allocate or recognize the cost of such assets over their useful lives; or to record the reduction in book value of an intangible asset over the benefit period of such asset; or to reflect consumption during the period of an asset that is not used in production.
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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
|
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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 |
|
|
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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
|
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- DefinitionAmount of noncash expense for share-based payment arrangement.
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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
|
|
|
|
|
|
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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
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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
|
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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
|
|
|
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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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