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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 June 30, 2024
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 August 2, 2024, there were 46,520,515 shares of common stock, par value $0.0001 per share, outstanding.
BEYOND
AIR, INC. AND SUBSIDIARIES
INDEX
TO FORM 10-Q FILING
FOR
THE PERIOD ENDED JUNE 30, 2024
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)
| |
June 30, 2024 | | |
March 31, 2024 | |
| |
| (Unaudited) | | |
| | |
ASSETS | |
| | | |
| | |
Current Assets | |
| | | |
| | |
Cash and cash equivalents | |
$ | 4,161 | | |
$ | 11,378 | |
Marketable securities | |
| 17,213 | | |
| 23,090 | |
Restricted cash | |
| 229 | | |
| 230 | |
Accounts receivable | |
| 475 | | |
| 319 | |
Inventory | |
| 2,391 | | |
| 2,127 | |
Other current assets and prepaid expenses | |
| 6,405 | | |
| 6,792 | |
Total current assets | |
| 30,874 | | |
| 43,936 | |
Licensed right to use technology | |
| 1,376 | | |
| 1,427 | |
Right-of-use lease assets | |
| 2,021 | | |
| 2,121 | |
Property and equipment, net | |
| 12,117 | | |
| 9,364 | |
Other assets | |
| 112 | | |
| 113 | |
TOTAL ASSETS | |
$ | 46,500 | | |
$ | 56,961 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable | |
$ | 3,114 | | |
$ | 1,948 | |
Accrued expenses and other current liabilities | |
| 7,674 | | |
| 8,402 | |
Operating lease liability, current portion | |
| 429 | | |
| 418 | |
Loans payable, current portion | |
| 536 | | |
| 800 | |
Total current liabilities | |
| 11,753 | | |
| 11,567 | |
| |
| | | |
| | |
Operating lease liability, net | |
| 1,790 | | |
| 1,898 | |
Long-term debt, net | |
| 14,946 | | |
| 14,721 | |
Warrant liability | |
| 56 | | |
| 275 | |
Derivative liability | |
| 256 | | |
| 1,314 | |
Total liabilities | |
| 28,801 | | |
| 29,775 | |
| |
| | | |
| | |
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, 45,900,821 shares issued and outstanding as of June 30, 2024 and March 31, 2024, respectively | |
| 5 | | |
| 5 | |
Treasury stock | |
| (25 | ) | |
| (25 | ) |
Additional paid-in capital | |
| 267,960 | | |
| 264,780 | |
Accumulated deficit | |
| (251,898 | ) | |
| (239,697 | ) |
Accumulated other comprehensive income (loss) | |
| 88 | | |
| (15 | ) |
Total stockholders’ equity attributable to Beyond Air, Inc. | |
| 16,130 | | |
| 25,048 | |
Non-controlling interest | |
| 1,570 | | |
| 2,138 | |
Total equity | |
| 17,699 | | |
| 27,186 | |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | |
$ | 46,500 | | |
$ | 56,961 | |
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)
| |
| | | |
| | |
| |
For the Three Months Ended | |
| |
June 30, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Revenues | |
$ | 683 | | |
$ | 59 | |
| |
| | | |
| | |
Cost of revenues | |
| (1,016 | ) | |
| (303 | ) |
| |
| | | |
| | |
Gross loss | |
| (332 | ) | |
| (244 | ) |
| |
| | | |
| | |
Operating expenses: | |
| | | |
| | |
| |
| | | |
| | |
Research and development | |
| (6,009 | ) | |
| (4,695 | ) |
Selling, general and administrative | |
| (7,239 | ) | |
| (10,936 | ) |
Total operating expenses | |
| (13,247 | ) | |
| (15,631 | ) |
| |
| | | |
| | |
Loss from operations | |
| (13,580 | ) | |
| (15,875 | ) |
| |
| | | |
| | |
Other income (expense) | |
| | | |
| | |
Dividend and interest income | |
| 361 | | |
| 409 | |
Interest and finance expense | |
| (964 | ) | |
| (158 | ) |
Change in fair value of warrant liability | |
| 219 | | |
| 324 | |
Change in fair value of derivative liability | |
| 1,058 | | |
| 512 | |
Foreign exchange gain / (loss) | |
| (146 | ) | |
| 8 | |
Estimated liability for contingent loss | |
| - | | |
| (198 | ) |
Other income / (expense) | |
| (2 | ) | |
| (77 | ) |
Total other income/(expense) | |
| 525 | | |
| 820 | |
| |
| | | |
| | |
| |
| | | |
| | |
Provision for income taxes | |
| - | | |
| - | |
| |
| | | |
| | |
Net loss | |
$ | (13,055 | ) | |
$ | (15,055 | ) |
| |
| | | |
| | |
Less : net loss attributable to non-controlling interest | |
| (854 | ) | |
| (960 | ) |
| |
| | | |
| | |
Net loss attributable to Beyond Air, Inc. | |
$ | (12,201 | ) | |
$ | (14,095 | ) |
| |
| | | |
| | |
Foreign currency translation gain | |
| 103 | | |
| 25 | |
| |
| | | |
| | |
Comprehensive loss attributable to Beyond Air, Inc. | |
$ | (12,098 | ) | |
$ | (14,070 | ) |
| |
| | | |
| | |
Net basic and diluted loss per share attributable to Beyond Air, Inc. | |
$ | (0.27 | ) | |
$ | (0.45 | ) |
| |
| | | |
| | |
Weighted average number of shares, outstanding basic and diluted | |
| 45,900,821 | | |
| 31,382,986 | |
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 MONTHS ENDED JUNE 30, 2024
(amounts
in thousands, except share data)
| |
Number | | |
Amount | | |
Stock | | |
Capital | | |
Deficit | | |
Income | | |
Interest | | |
Equity | |
| |
Common Stock | | |
Treasury | | |
Additional Paid-in | | |
Accumulated | | |
Accumulated Other Comprehensive
(loss) | | |
Non-Controlling | | |
Total | |
| |
Number | | |
Amount | | |
Stock | | |
Capital | | |
Deficit | | |
Income | | |
Interest | | |
Equity | |
Balance as of April 1, 2024 | |
| 45,900,821 | | |
$ | 5 | | |
$ | (25 | ) | |
$ | 264,780 | | |
$ | (239,697 | ) | |
$ | (15 | ) | |
$ | 2,138 | | |
$ | 27,186 | |
Issuance of common stock warrants | |
| - | | |
| - | | |
| - | | |
| 86 | | |
| - | | |
| - | | |
| - | | |
| 86 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| 3,093 | | |
| - | | |
| - | | |
| 285 | | |
| 3,379 | |
Other comprehensive income | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 103 | | |
| - | | |
| 103 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| (12,201 | ) | |
| - | | |
| (854 | ) | |
| (13,055 | ) |
Balance as of June 30, 2024 | |
| 45,900,821 | | |
$ | 5 | | |
$ | (25 | ) | |
$ | 267,960 | | |
$ | (251,898 | ) | |
$ | 88 | | |
$ | 1,570 | | |
$ | 17,699 | |
FOR
THE THREE MONTHS ENDED JUNE 30, 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 | |
Balance | |
| 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 | |
Balance | |
| 31,711,317 | | |
$ | 3 | | |
$ | (25 | ) | |
$ | 228,949 | | |
$ | (193,550 | ) | |
$ | 78 | | |
$ | 3,688 | | |
$ | 39,143 | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(amounts
in thousands)
| |
| | | |
| | |
| |
For the Three Months Ended | |
| |
June 30, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Cash flows from operating activities | |
| | | |
| | |
Net loss | |
$ | (13,055 | ) | |
$ | (15,055 | ) |
Adjustments to reconcile net loss to net cash used in operating activities | |
| | | |
| | |
Depreciation and amortization | |
| 685 | | |
| 309 | |
Amortization of licensed right to use technology | |
| 51 | | |
| 52 | |
Stock-based compensation | |
| 3,379 | | |
| 6,115 | |
Amortization of debt discount | |
| 409 | | |
| 57 | |
Change in fair value of warrant liability | |
| (219 | ) | |
| (324 | ) |
Change in fair value of derivative liability | |
| (1,058 | ) | |
| (512 | ) |
Amortization of operating lease assets | |
| 94 | | |
| 90 | |
Un-realized gain in marketable securities | |
| 90 | | |
| (75 | ) |
Foreign currency adjustments | |
| - | | |
| (8 | ) |
Changes in: | |
| | | |
| | |
Grant receivable | |
| - | | |
| (5 | ) |
Inventory | |
| (338 | ) | |
| (209 | ) |
Accounts receivable | |
| (156 | ) | |
| (44 | ) |
Other current assets and prepaid expenses | |
| 391 | | |
| 74 | |
Accounts payable | |
| 491 | | |
| (306 | ) |
Accrued expenses | |
| (848 | ) | |
| (7,228 | ) |
Operating lease liabilities | |
| (97 | ) | |
| (84 | ) |
Net cash used in operating activities | |
$ | (10,180 | ) | |
$ | (17,153 | ) |
| |
| | | |
| | |
Cash flows from investing activities | |
| | | |
| | |
Proceeds from sale of marketable securities | |
| 20,361 | | |
| 886 | |
Purchase of property and equipment | |
| (2,673 | ) | |
| (795 | ) |
Net cash provided by and (used in) investing activities | |
$ | 3,114 | | |
$ | (9,653 | ) |
| |
| | | |
| | |
Cash flows from financing activities | |
| | | |
| | |
Proceeds from issuance of common stock through at the market offerings | |
| - | | |
| 5,814 | |
Proceeds from issuance of common stock through exercise of stock options | |
| - | | |
| 217 | |
Proceeds from loan | |
| - | | |
| 15,817 | |
Payment of loan | |
| (264 | ) | |
| (280 | ) |
Net cash (used in) and provided by financing activities | |
$ | (264 | ) | |
$ | 21,567 | |
| |
| | | |
| | |
Effect of exchange rate changes on cash and cash equivalents | |
| 111 | | |
| 40 | |
| |
| | | |
| | |
Decrease in cash, cash equivalents and restricted cash | |
$ | (7,218 | ) | |
$ | (5,199 | ) |
Cash, cash equivalents and restricted cash at beginning of period | |
| 11,608 | | |
| 36,768 | |
Cash, cash equivalents and restricted cash at end of period | |
$ | 4,390 | | |
$ | 31,569 | |
Supplemental disclosure of non-cash investing and financing activities | |
| | | |
| | |
Debt discount | |
$ | 621 | | |
$ | 4,541 | |
End of term loan liability | |
$ | (438 | ) | |
$ | (613 | ) |
Warrant liability | |
$ | - | | |
$ | (885 | ) |
Derivative liability | |
$ | - | | |
$ | (1,361 | ) |
Fixed assets recorded in accounts payable and accrued assets | |
$ | 749 | | |
$ | - | |
Supplemental disclosure of cash flow items: | |
| | | |
| | |
Interest paid | |
$ | 556 | | |
$ | 289 | |
Income taxes paid | |
$ | - | | |
$ | - | |
The
accompanying notes are an integral part of these condensed consolidated financial statements.
BEYOND
AIR, INC. AND ITS 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 phase 1 human clinical trials.
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 the end of 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 ITS 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 June 30, 2024 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, 2024 (the “2024
Annual Report”), filed with the U.S. Securities and Exchange Commission (the “SEC”) on June 24, 2024. 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 2024 Annual Report on Form 10-K.
Principles
of Consolidation
These
unaudited condensed consolidated financial statements include the accounts of the Company and the accounts of all of the
Company’s subsidiaries 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 result 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 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. Of the restricted cash originally recorded
in the unaudited condensed consolidated statement of cash flows for the three months ended June 30, 2023, $2.5 million has been reclassified
and is now recorded in prepaid assets. These reclassifications had no effect on the reported results of operations.
Use
of Estimates
The
preparation of financial statements in conformity with generally accepted accounting principles in the United States (“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 significantly differ from those estimates. On an ongoing basis, the Company evaluates its significant estimates
and assumptions including expense recognition and accrual assumptions under consulting and clinical trial agreements, stock-based compensation,
impairment assessments, accounting for licensed rights to use technologies and other long-lived assets, contingency recognition and accruals
and the determination of valuation allowance requirements on deferred tax attributes.
Going
Concern, Liquidity and Other Uncertainties
The
Company used cash in operating activities of $10.2 million for the three months ended June 30, 2024, and has accumulated losses attributable
to the stockholders of Beyond Air of $251.9 million. The Company had cash, cash equivalents and marketable securities of $21.4 million
as of June 30, 2024.
The
Company expects to incur net losses and have significant cash outflows for at least the next year, 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 the Company to meet its obligations.
Management
currently has various funding options in place to raise additional capital such as a debt line of $12.5 million with Avenue (as defined below) and its affiliates,
subject to the agent and lenders receiving investment committee approval and negotiations of the terms and conditions between both parties, (Note 11),
an ATM sales agreement with $32.9 million of available funds (Note 4), assets that can be leveraged such as Beyond Cancer, Autism, LungFit
PH international partnerships, LungFit PRO international partnerships and LungFit GO partnerships. Additionally, in January 2022 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. The securities purchase agreement entered into in March 2024 contains restrictions to the Company’s
ability to enter into variable rate transactions for a period of 6 months.
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. A combination study with anti-PD1 therapy is expected to begin before the
end of calendar 2024.
The
Company’s future capital needs and the adequacy of its available funds will depend on many factors, including, but not necessarily
limited to the success and costs of commercialization of the Company’s approved product and the actual cost and time necessary
for current and anticipated preclinical studies, clinical trials and other actions needed to obtain certification or regulatory approval
of the Company’s product candidates.
The
Company will be required to raise additional funds through equity or debt securities offerings or strategic collaboration and/or licensing
agreements in order to fund operations if it is unable to generate enough product or royalty revenues, if any. Such financing may not
be available on acceptable terms, or at all, and the Company’s failure to raise capital when needed could have a material adverse
effect on its strategic objectives, results of operations and financial condition.
The accompanying unaudited 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 ITS 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.
Lease
Revenue Recognition
The
Company generates revenue from the leases of its LungFit® PH devices to its customers under fixed fee arrangements over periods of
up to three years. The fixed fee is typically broken down into ratable monthly payments over the term of the arrangement. The Company’s
customers include hospitals and medical facilities. The Company’s LungFit® PH leases include filters, calibration gas, bagging
kits, cables, adapters, and other components and accessories required to use the LungFit® PH device (the “Consumables”).
The Consumables’ quantities are varied and may be supplied upon demand of the customers and are unlimited, or the arrangement may
provide for the maximum quantities available to the customer over the term of the arrangement. The Company’s LungFit® PH leases
also include maintenance and training required to use the LungFit® PH device, as well as device back-up services (the “Services”),
which are recorded in cost of revenue.
The
Company accounts for its rental arrangements of LungFit® PH devices in accordance with Accounting Standards Codification 842, Leases
(“ASC 842”). Under ASC 842, leases may be classified as either financing, sales-type, or operating, and the Company is required
to disclose key information about leasing arrangements. The classification determines the pattern of revenue recognition and classification
within the statement of operations and comprehensive loss. The Company typically classifies the rental arrangement of its LungFit®
PH contracts as operating leases. The Company’s leases do not contain any restrictive covenants or any material residual value
guarantees. The Company’s equipment leases may contain renewal options which range from one month to two years. The lease term
is adjusted for renewal or termination options that the Company believe the customer is reasonably certain to exercise.
The
Company elected the practical expedient applied to operating leases not to separate lease and non-lease components as long as the lease
and at non-lease components have the same timing and pattern of transfer. As such, the non-lease components, including the Consumables
and Services, are combined with the predominant lease component. The total fixed fees that the Company is reasonably certain to collect
are recognized on a straight line basis over the term of the arrangement. Additionally, the Company made an accounting policy election
to present LungFit® PH revenue net of sales and other similar taxes.
Amounts
billed in advance of performance obligations being satisfied are recognized as deferred revenue.
At
the lease commencement date, the Company will defer initial direct costs, including commission expense and the cost is recognized over
the lease term on the same basis as lease income.
The
Company records the costs of shipping related to contract devices and consumables in cost of revenue in its consolidated statements of
operations.
See
Note 12 to the unaudited condensed consolidated financial statements for more information regarding leasing arrangements.
Fair
Value Measurements
As
of June 30, 2024 and March 31, 2024, the Company’s financial instruments included restricted cash, marketable securities, accounts
payable, long-term debt, liability classified warrants and derivative liabilities. The carrying amounts reported in the accompanying
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 ITS 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 at June 30, 2024 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 | |
| 17,213 | | |
| 17,213 | | |
| - | | |
| - | |
Mutual funds | |
| - | | |
| - | | |
| - | | |
| - | |
Total assets measured and recorded at fair value | |
$ | 17,213 | | |
$ | 17,213 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities : | |
| | | |
| | | |
| | | |
| | |
Warrant liability | |
$ | 56 | | |
$ | - | | |
$ | - | | |
$ | 56 | |
Derivative liability | |
| 256 | | |
| - | | |
| - | | |
| 256 | |
Total liabilities measured and recorded at fair value | |
$ | 312 | | |
$ | 0 | | |
$ | - | | |
$ | 312 | |
The
fair value amounts at March 31, 2024 are:
(in thousands) | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Marketable securities : | |
| | | |
| | | |
| | | |
| | |
Corporate debt securities | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
Government securities | |
| 16,388 | | |
| 16,388 | | |
| - | | |
| - | |
Mutual funds | |
| 6,702 | | |
| 6,702 | | |
| - | | |
| - | |
Total assets measured and recorded at fair value | |
$ | 23,090 | | |
$ | 23,090 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities : | |
| | | |
| | | |
| | | |
| | |
Warrant liability | |
$ | 275 | | |
$ | - | | |
$ | - | | |
$ | 275 | |
Derivative liability | |
| 1,314 | | |
| - | | |
| - | | |
| 1,314 | |
Total liabilities measured and recorded at fair value | |
$ | 1,589 | | |
$ | - | | |
$ | - | | |
$ | 1,589 | |
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)
Level
3 Valuation
The
common stock warrants issued in connection with the Loan and Security Agreement in June 2023 (Note 11) are recorded as a warrant
liability within the unaudited condensed consolidated balance sheet at June 30, 2024 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
At June 30, 2024 | |
Warrants | | |
Derivative | |
Expected term (in years) | |
| 4 | | |
| 3 | |
Volatility | |
| 90 | % | |
| 90 | % |
Risk-free rate | |
| 4.24 | % | |
| 4.52 | % |
At March 31, 2024 | |
Warrants | | |
Derivative | |
Expected term (in years) | |
| 4.25 | | |
| 3.25 | |
Volatility | |
| 88 | % | |
| 86 | % |
Risk-free rate | |
| 4.09 | % | |
| 4.38 | % |
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 three months ended June 30, 2024 (in thousands):
SCHEDULE
OF CHANGES IN FAIR VALUE OF WARRANTS AND DERIVATIVES
| |
Warrants | | |
Derivative | |
Balance at March 31,2024 | |
$ | 275 | | |
$ | 1,314 | |
Issuances | |
| - | | |
| - | |
Change in fair value | |
| (219 | ) | |
| (1,058 | ) |
Balance at June 30, 2024 | |
$ | 56 | | |
$ | 256 | |
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 investments 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 June 30, 2024 and March 31, 2024, restricted cash included approximately $0.2 million and $0.2 million, respectively.
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentrations of credit risk consist of cash accounts in a financial institution,
which at times, may exceed the federal depository insurance coverage of $250,000 in the United States, A$250,000 in Australia, $25,000
in Bermuda, €100,000 in Ireland and €100,000 in Cyprus. There is currently no official federal depository insurance in Israel.
The Company has not experienced losses on these accounts, and management believes the Company is not exposed to significant risks on
such accounts. As of June 30, 2024, the Company had greater than $250,000 at United States financial institutions, greater than A$250,000
at Australian financial institutions, greater than €100,000 at Irish financial institutions and also has funds on deposit in Israel.
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, MARKETABLE SECURITIES AND RESTRICTED CASH
(in thousands) | |
June 30, 2024 | | |
March 31, 2024 | |
Cash and cash equivalents | |
$ | 4,161 | | |
$ | 11,378 | |
Restricted cash | |
| 229 | | |
| 230 | |
Total cash, cash equivalents and restricted cash | |
$ | 4,390 | | |
$ | 11,608 | |
Marketable securities: | |
| | | |
| | |
Marketable debt securities | |
| - | | |
| - | |
Corporate debt securities | |
$ | - | | |
$ | - | |
U.S. government securities | |
| 17,213 | | |
| 16,388 | |
Mutual fund (ultra-short-term income) | |
| - | | |
| 6,702 | |
Total marketable securities | |
$ | 17,213 | | |
$ | 23,090 | |
| |
| | | |
| | |
Total cash, cash equivalents, marketable securities and restricted cash | |
$ | 21,603 | | |
$ | 34,698 | |
The
following table summarizes our short-term marketable securities with unrealized gains and losses as of June 30, 2024, 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 | |
| 17,213 | | |
| 90 | |
Mutual fund (ultra-short-term income) | |
| - | | |
| - | |
Total short-term marketable securities | |
$ | 17,213 | | |
$ | 90 | |
The
following table summarizes our short-term marketable securities with unrealized gains and losses as of March 31, 2024, aggregated by
major security type:
(in thousands) | |
Fair Value | | |
Unrealized Gains and (Losses) | |
Corporate debt securities | |
$ | - | | |
$ | - | |
U.S. government securities | |
| 16,388 | | |
| 117 | |
Mutual fund (ultra-short-term income) | |
| 6,702 | | |
| 6 | |
Total short-term marketable securities | |
$ | 23,090 | | |
$ | 123 | |
All
marketable securities are A- or higher rated. No marketable securities have maturities greater than 12 months. All investments are level
1 investments.
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)
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 June 30, 2024,
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 at June 30, 2024:
SCHEDULE
OF SEGMENT FINANCIAL INFORMATION BY BUSINESS SEGMENT
(in thousands) | |
Beyond Air | | |
Beyond Cancer | | |
Total | |
Cash, cash equivalents, marketable securities and certain restricted cash | |
$ | 13,371 | | |
$ | 8,230 | | |
$ | 21,603 | |
All other assets | |
| 24,144 | | |
| 755 | | |
| 24,897 | |
Total assets | |
$ | 37,515 | | |
$ | 8,985 | | |
$ | 46,500 | |
Total liabilities | |
$ | (27,722 | ) | |
$ | (1,078 | ) | |
$ | (28,801 | ) |
Net assets | |
$ | 9,793 | | |
$ | 7,907 | | |
$ | 17,699 | |
Non-controlling interests | |
$ | - | | |
$ | 1,570 | | |
$ | 1,570 | |
The
following table summarizes segment financial information by business segment at March 31, 2024:
(in thousands) | |
Beyond Air | | |
Beyond Cancer | | |
Total | |
Cash, cash equivalents, marketable securities and certain restricted cash | |
$ | 23,591 | | |
$ | 10,877 | | |
$ | 34,468 | |
All other assets | |
| 21,747 | | |
| 746 | | |
| 22,493 | |
Total assets | |
$ | 45,338 | | |
$ | 11,623 | | |
$ | 56,961 | |
Total liabilities | |
$ | (28,810 | ) | |
$ | (965 | ) | |
$ | (29,775 | ) |
Net assets | |
$ | 16,528 | | |
$ | 10,658 | | |
$ | 27,186 | |
Non-controlling interests | |
$ | - | | |
$ | 2,138 | | |
$ | 2,138 | |
The
following table summarizes segment financial performance by business segment for the three months ended June 30, 2024:
(in thousands) | |
Beyond Air | | |
Beyond Cancer | | |
Total | |
Revenue | |
$ | 683 | | |
$ | - | | |
$ | 683 | |
Net loss for the three months ended June 30, 2024 | |
$ | (8,786 | ) | |
$ | (4,269 | ) | |
$ | (13,055 | ) |
The
following table summarizes segment financial performance by business segment for the three months ended June 30, 2023:
(in thousands) | |
Beyond Air | | |
Beyond Cancer | | |
Total | |
| |
| | |
| | |
| |
Revenue | |
$ | 59 | | |
$ | - | | |
$ | 59 | |
Net loss for the three months ended June 30, 2023 | |
$ | (10,256 | ) | |
$ | (4,799 | ) | |
$ | (15,055 | ) |
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)
Research
and Development
Research
and development expenses are charged to the unaudited 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 June 30, 2024 and
June 30, 2023, the Company did not
receive any AU Tax Rebates.
Supplier
Concentration
The
Company relies on third-party suppliers to provide materials for its devices and consumables. In the three months ended June 30, 2024,
the Company purchased approximately 87% of its materials from one third party vendor. In the three months ended June 30, 2023, the Company
purchased approximately 84% of its materials from two third-party vendors, with these vendors representing 65% and 19%, respectively.
Leases
Operating
lease assets are included within operating lease right-of-use assets, and the corresponding operating lease obligation on the consolidated
balance sheets as of June 30, 2024 and March 31, 2024 in accordance with ASC 842, Leases. The Company has elected not to present
short-term leases as these leases have a lease term of 12 months or less at lease inception and do not contain purchase options or renewal
terms that the Company is reasonably certain to exercise. All other lease assets and lease liabilities are recognized based on the present
value of lease payments over the lease term at commencement date. Because most of the Company’s leases do not provide an implicit
rate of return, the Company used an incremental borrowing rate based on the information available at adoption date in determining the
present value of lease payments.
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
3 PROPERTY AND EQUIPMENT
Property
and equipment consist of the following:
SCHEDULE OF PROPERTY AND EQUIPMENT
(in thousands) | |
June 30, 2024 | | |
March 31, 2024 | |
| |
| | |
| |
Clinical and medical equipment | |
$ | 2,174 | | |
$ | 2,174 | |
Equipment deployable as part of a service offering | |
| 11,638 | | |
| 8,208 | |
Computer equipment | |
| 855 | | |
| 860 | |
Furniture and fixtures | |
| 534 | | |
| 534 | |
Leasehold improvements | |
| 612 | | |
| 612 | |
Property
and equipment, gross | |
| 15,812 | | |
| 12,388 | |
Accumulated depreciation | |
| (3,695 | ) | |
| (3,024 | ) |
Property
and equipment, net | |
$ | 12,117 | | |
$ | 9,364 | |
Depreciation
and amortization for the three months ended June 30, 2024 and June 30, 2023 was $0.7 million and $0.3 million, respectively.
NOTE
4 STOCKHOLDERS’ EQUITY
On
February 4, 2022, the Company entered into an At-The-Market Equity Offering Sales Agreement with Truist Securities, Inc (the “2022 ATM”), allowing the Company to sell its common stock for aggregate sales proceeds of up to $50
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.
During
the three months ended June 30, 2024, the Company received net proceeds of $0.0
million from the sale shares of common stock
through the 2022 ATM. During the three months ended June 30, 2023, the Company received net proceeds of $5.8
million from the sale of 930,232
shares of common stock. As of June 30, 2024,
there were $32.9
million in funds available under the 2022 ATM.
On
March 20, 2024, the Company, entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain
institutional and accredited investors, including certain directors and officers of the Company, (the “Purchasers”) pursuant
to which the Company sold, in a registered direct offering, an aggregate of (i) 9,638,556 shares (the “Shares”) of common
stock and (ii) 9,638,556 common stock purchase warrants (the “common stock warrants”) to purchase up to 9,638,556 shares
of Common Stock (the “common stock warrant shares”) for gross proceeds of $16 million (which includes $1.2 million from related
parties). Members of the Board of the Directors and certain executives of the Company are considered related parties to this offering.
These warrants contain a call provision which can be exercised if the Company reports $4.5 million of net sales in the quarter ending
March 31, 2025. The combined offering price per share and accompanying common stock warrant is $1.66. Subject to certain ownership limitations,
each common stock warrant is immediately exercisable upon issuance at an exercise price of $2.25 per share and expires three years from
the date of issuance. The offering closed on March 22, 2024. The Company received net proceeds of $14.6 million after deductions for
placement agent commissions and other offering costs of $1.1 million and $0.3 million, respectively.
On
March 20, 2024, the Company also entered into a placement agency agreement (the “Placement Agency Agreement”) with Roth
Capital Partners, LLC and Laidlaw & Company (UK) Ltd. (the “Co-Placement Agents”) as the co-placement agents in
connection with the March 20, 2024 offering. Pursuant to the terms of the Placement Agency Agreement, the Co-Placement Agents agreed
to use their reasonable best efforts to arrange for the sale of the securities in the offering. As compensation to the Co-Placement
Agents, the Company paid the Co-Placement Agents a cash fee of 7%
of the aggregate gross proceeds raised in the offering and the reimbursement of certain expenses and legal fees.
In
addition, under the Securities Purchase Agreement, until 90 days after March 22, 2024, subject to certain exceptions, neither the Company
nor any of its subsidiaries were allowed to (i) issue, enter into any agreement to issue or announce the issuance or proposed issuance of any common
stock or common stock equivalents or (ii) file any registration statement or amendment or supplement thereto.
In
addition, from the date of the Securities Purchase Agreement, the Company has agreed not to enter into variable rate transactions (as
defined in the Securities Purchase Agreement) for a period of six (6) months from the closing of the offering, subject to certain exceptions.
Stock
Option Plans
The
Company’s Sixth 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 10, 2024, 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 2024 annual stockholder meeting
on March 8, 2024. The 2013 BA Plan has 13,600,000 shares authorized for issuance. As of June 30, 2024, 421,558 shares were available
under the 2013 BA Plan.
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
4 STOCKHOLDERS’ EQUITY (continued)
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 three months ended June 30, 2024 is as follows:
SCHEDULE OF RESTRICTED STOCK AWARDS
| |
Number Of Shares | | |
Weighted Average Grant Date Fair Value | |
| |
| | |
| |
Unvested as of April 1, 2024 | |
| 618,900 | | |
$ | 6.98 | |
Granted | |
| - | | |
| - | |
Vested | |
| - | | |
| - | |
Forfeited | |
| (6,000 | ) | |
| 14.36 | |
Unvested as of June 30, 2024 | |
| 612,900 | | |
$ | 6.91 | |
Stock-based
compensation expense related to these grants for the three months ended June 30, 2024 and June 30, 2023 was $0.3 million and $0.7 million,
respectively.
As
of June 30, 2024, the Company had unrecognized stock-based compensation expense for the restricted stock unit awards in the 2013 BA Plan
of approximately $1.6 million which is expected to be expensed over the weighted average remaining service period of 1.6 years.
A
summary of the change in options for the three months ended June 30, 2024 is as follows:
SCHEDULE OF 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, 2024 | | |
| 11,283,469 | | |
$ | 4.45 | | |
| 8.0 | | |
$ | 760 | |
Granted | | |
| 27,500 | | |
| 4.25 | | |
| - | | |
| - | |
Exercised | | |
| - | | |
| - | | |
| - | | |
| - | |
Forfeited | | |
| (144,125 | ) | |
| 4.94 | | |
| - | | |
| - | |
Outstanding as of June 30, 2024 | | |
| 11,166,844 | | |
$ | 4.41 | | |
| 7.76 | | |
$ | 0 | |
Exercisable as of June 30, 2024 | | |
| 4,758,469 | | |
$ | 5.44 | | |
| 5.95 | | |
$ | 0 | |
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
4 STOCKHOLDERS’ EQUITY (continued)
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 Ltd.’s common stock.
The vesting terms of the options issued under the 2021 BC Plan are generally four years and they expire ten years from the grant date.
On November 3, 2022, the Company’s Board of Directors approved an amendment to reserve for issuance an additional 2,000,000 shares
of common stock. The 2021 BC Plan has 4,000,000 shares authorized for issuance. As of June 30, 2024, 243,250 common shares were available
under the 2021 BC Plan.
SCHEDULE
OF 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, 2024 | | |
| 3,819,000 | | |
$ | 5.50 | | |
| 8.3 | | |
$ | - | |
Granted | | |
| - | | |
| - | | |
| - | | |
| - | |
Exercised | | |
| - | | |
| - | | |
| - | | |
| - | |
Forfeited | | |
| (62,250 | ) | |
| 5.50 | | |
| - | | |
| - | |
Outstanding as of June 30, 2024 | | |
| 3,756,750 | | |
$ | 5.50 | | |
| 8.0 | | |
$ | 0 | |
Exercisable as of June 30, 2024 | | |
| 1,354,000 | | |
$ | 5.50 | | |
| 7.8 | | |
$ | 0 | |
As
of June 30, 2024, the Company had unrecognized stock-based compensation expense in the 2013 BA Plan of approximately $9.0
million which is expected to be expensed over
the weighted average remaining service period of 1.8
years
As
of June 30, 2024, the Company had unrecognized stock-based compensation expense in the 2021 BC Plan of approximately $7.6 million which
is expected to be expensed over the weighted average remaining service period of 1.4 years.
The
following was utilized to calculate the fair value of options on the date of grant:
SCHEDULE OF FAIR VALUE OF OPTION
| |
June 30, 2024 | |
|
June 30, 2023 | |
Risk-free interest rate | |
| 4.3-4.5 | % |
|
| 3.5 - 3.9 | % |
Expected volatility (Beyond Air) | |
| 83.5 – 83.8 | % |
|
| 81.6-82.7 | % |
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 months ended June 30, 2024 and June 30, 2023:
SCHEDULE
OF STOCK-BASED COMPENSATION EXPENSE
|
|
2024 |
|
|
2023 |
|
|
|
Three Months Ended |
|
(in thousands) |
|
June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
629 |
|
|
$ |
1,206 |
|
General and administrative |
|
|
2,750 |
|
|
|
4,911 |
|
Total stock-based compensation expense |
|
$ |
3,379 |
|
|
$ |
6,115 |
|
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
4 STOCKHOLDERS’ EQUITY (continued)
Warrants
A
summary of the Company’s outstanding warrants as of June 30, 2024 is as follows:
SUMMARY
OF COMPANY’S OUTSTANDING WARRANTS
Warrant Holders | |
Number of Warrants | | |
Exercise Price | | |
Intrinsic Value (in thousands) | | |
Date of Expiration | |
| |
| | |
| | |
| | |
| |
March 2020 loan | |
| 172,187 | | |
$ | 7.26 | | |
$ | - | | |
| March 2025 | |
NitricGen agreement | |
| 80,000 | | |
$ | 6.90 | | |
| - | | |
| January 2028 | |
Avenue agreement | |
| 233,843 | | |
$ | 1.66 | | |
| - | | |
| June 2028 | |
March 2024 Roth/Laidlaw raise | |
| 9,638,556 | | |
$ | 2.25 | | |
| - | | |
| March 2027 | |
Avenue extension agreement | |
| 100,000 | | |
$ | 1.28 | | |
| - | | |
| June 2029 | |
Total | |
| 10,224,586 | | |
$ | 2.35 | | |
$ | - | | |
| | |
On
June 21, 2024, warrants to purchase up to an aggregate of 100,000
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 return for extending the interest-only period for an additional 6 months on the
Loan and Security Agreement with Avenue Capital. The warrant exercise price was calculated at the average closing share price for
the 5 trading days prior to June 21, 2024. No warrants were exercised in this period.
NOTE
5 OTHER CURRENT ASSETS AND PREPAID EXPENSES
A
summary of current assets and prepaid expenses is as follows (in thousands):
SCHEDULE OF CURRENT ASSETS AND PREPAID EXPENSES
| |
June 30, 2024 | | |
March 31, 2024 | |
Prepaid research and development | |
$ | 148 | | |
$ | 104 | |
Prepaid insurance | |
| 605 | | |
| 886 | |
Prepaid rents and tenant improvements | |
| 48 | | |
| 49 | |
Value added tax receivable | |
| 179 | | |
| 229 | |
Deposits to secure manufacturing materials | |
| 5,019 | | |
| 5,019 | |
Demonstration materials | |
| 145 | | |
| 228 | |
Other | |
| 261 | | |
| 277 | |
Total | |
$ | 6,405 | | |
$ | 6,792 | |
Prepaid
expenses and other current assets | |
$ | 6,405 | | |
$ | 6,792 | |
NOTE
6 ACCRUED EXPENSES
A
summary of the accrued expenses as of June 30, 2024 and March 31, 2024 is as follows (in thousands):
SUMMARY OF ACCRUED EXPENSES
| |
June 30, 2024 | | |
March 31, 2024 | |
Research and development | |
$ | 848 | | |
$ | 965 | |
Professional fees | |
| 575 | | |
| 466 | |
Employee salaries and benefits | |
| 1,280 | | |
| 1,302 | |
Contingent litigation and settlements (Note 10) | |
| 200 | | |
| 400 | |
Circassia settlement – current portion (Note 8) | |
| 4,500 | | |
| 4,500 | |
Deferred revenue | |
| - | | |
| 138 | |
Goods received not invoiced | |
| 130 | | |
| 356 | |
Other | |
| 141 | | |
| 275 | |
Total short-term accrued expenses | |
$ | 7,674 | | |
$ | 8,402 | |
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
7 BASIC AND DILUTED NET INCOME (LOSS) PER SHARE OF COMMON STOCK
In
accordance with ASC 260, Earnings Per Share, warrants that are accounted for as liabilities which are potentially dilutive have
not been included in diluted earnings per share as they would have been anti-dilutive during the three months ended June 30, 2024.
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
| |
June 30, 2024 | | |
June 30, 2023 | |
| |
| | |
| |
Common stock warrants | |
| 10,224,586 | | |
| 694,363 | |
Common stock options | |
| 11,166,844 | | |
| 8,132,952 | |
Restricted shares | |
| 612,900 | | |
| 1,095,300 | |
Loan and Security – conversion feature (note 11) | |
| 1,390,176 | | |
| 392,465 | |
Total | |
| 23,394,506 | | |
| 10,315,080 | |
Anti-dilutive
securities | |
| 23,394,506 | | |
| 10,315,080 | |
NOTE
8 CIRCASSIA 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 installments. The first payment of $2.5 million
was triggered upon FDA approval for the LungFit® PH (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
As of June 30, 2024 and March 31, 2024 $4.5 million
is included in accrued liabilities and is payable in the second fiscal quarter of 2025.
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 with CFF, the funding will be
allocated to the ongoing LungFit® GO NTM pilot study. 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. For the three months ended June 30,
2024 and June 30, 2023, the Company recorded $0
and $5
thousand as a reduction to R&D expense, respectively. 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. The trial is now successfully completed and no further payments are expected.
BEYOND
AIR, INC. AND ITS 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 $0.5
million 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 $0.1 million upon the execution
of the NitricGen Agreement, $0.1 million 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 June 30, 2024 the remaining future milestone payments total $0.3 million.
Supply
Agreement and Purchase Order
In
August 2020, the Company entered into a supply agreement with an initial expiration date of 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. As of the date of this report, the Company has not provided such notice. The Company has opened several non-cancellable
purchase orders and the outstanding amount remaining under the purchase order as of June 30, 2024 was approximately $1.4
million with this supplier. This supplier holds $5.0
million of restricted cash to partially secure materials on the Company’s behalf recorded in other current assets and prepaid
expenses.
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.
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 the Company paid
$3.1 million for defense and indemnity costs in the quarter ended September 30, 2023.
From
time to time, we are involved in various legal matters arising in the normal course of business. We do not expect the outcome of such
proceedings, either individually or in the aggregate, to have a material effect on our financial position, cash flows or results of operations.
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
11 LOANS
LOAN
AND SECURITY AGREEMENT
On
June 15, 2023 (the “Closing Date”), Beyond Air, Inc. and its wholly-owned subsidiary, Beyond Air Ltd., 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 September 30, 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 installments 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. For the quarter ended June 30, 2024 and June 30 2023 , the Company incurred and paid $0.6 million and $0 million
respectively in interest on the loan.
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 on deposit in a US bank. 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 (1,390,176
of common stock at $2.158),
for the life of the loan (“the “Conversion Right”).
On
June 21, 2024, the Company, in return for extending the interest-only period for an additional 6 months on the Loan and Security
Agreement with Avenue Capital, entered into an agreement to issue warrants to purchase up to 100,000
shares of common stock at an exercise price of $1.28
per share and an additional end of term payment of $87,500
plus legal and amendment fees, which resulted in an increase to debt discount and this increase will be amortized over the remainder
of the loan period. As the transaction did not have a substantially different impact to the terms of the original instrument, the
company determined that this transaction was a modification to the original loan and security agreement. The maturity of the debt
remains unchanged.
Upon consummation
of the offering contemplated by the Securities Purchase Agreement and in accordance
with their original terms, the 233,843 liability classified warrants issued the lenders
had their original exercise price of $5.88 per share repriced to $1.66 per share and the original conversion price of $7.64 per
share of the Conversion Right was reset to $2.16 per share. The previously issued warrants and bifurcated conversion feature have
been, and will continue to be, liability classified and remeasured at each reporting period until they are exercised, expire,
reclassified or otherwise settled. The adjustment for the exercise price has been recorded as a revaluation of warrants fair value
and revaluation of derivative fair value respectively in the statement of operations.
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.
The
agreement contains an end of term liability of $1.1
million, equal to 3.5%
of the committed funds plus an additional end of term payment of $0.1 million.
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
11 LOANS (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) | |
June 30 | |
| |
| |
2025 | |
| - | |
2026 | |
| 8,750 | |
2027 | |
| 8,750 | |
Total | |
$ | 17,500 | |
Components
of Loan and Security Agreement
SCHEDULE OF LOAN AND SECURITY AGREEMENT
| |
June 30, 2024 | | |
March 31, 2024 | |
| |
| | |
| |
Amount outstanding | |
$ | 17,500 | | |
$ | 17,500 | |
Debt discount | |
| (5,163 | ) | |
| (4,541 | ) |
Amortization of debt discount | |
| 1,559 | | |
| 1,149 | |
Final payment liability | |
| 1,050 | | |
| 613 | |
Total | |
$ | 14,946 | | |
$ | 14,721 | |
NOTE
12 – LEASE REVENUES
The
Company leases the LungFit® PH device to customers and receives a fixed rental fee over the term of the arrangement. Contract terms
(generally one-to-three years) vary by customer and may include options to terminate the contract or options to extend the contract.
The LungFit® PH lease agreements are accounted for as operating leases. The non-lease components, including consumables and device-related
services are combined with the predominant lease component under the practical expedient. The fixed rental fee is recognized over the
period of the lease agreement on a straight-line basis.
The
Company recognized $0.6 million and $0.1 million in LungFit® PH lease revenues for the three months ended June 30, 2024 and June
30,2023, respectively, included revenues in the accompanying consolidated statements of operations. The Company received approximately
$0.4 million and $0 million in cash associated with leases which the Company is the for lessor for the three months ended June 30, 2024
and June 30,2023, respectively. The Company has recorded $0.1 million and $0 million in deferred revenue as of June 30, 2024 and June
30, 2023, respectively.
The
following schedule presents the minimum future lease payments under the LungFit® PH lease arrangements that were in place as of June
30, 2024 (in thousands):
SCHEDULE
OF MATURITY OF FUTURE LEASE PAYMENTS
Future lease payments under the LungFit® PH lease arrangements | |
June 30 | |
| |
| |
2025 | |
$ | 2,155 | |
2026 | |
| 1,975 | |
2027 | |
| 997 | |
2028 | |
| 29 | |
Total | |
$ | 5,156 | |
The
LungFit® PH devices are included in Property and Equipment (Note 3) and have the useful life of five years. Depreciation expense
related to leased LungFit® PH devices was $0.5 million and $0.2 million for the three months ended June 30, 2024 and June 30, 2023,
respectively. The depreciation expense related to customer leased devices is included in the cost of revenue in the consolidated statements
of operations and comprehensive loss.
Capitalized
sales commissions
Sales
commissions related to obtaining LungFit® PH lease agreements are accounted for as initial direct costs and are capitalized and amortized
on a straight-line basis over the lease term. Total capitalized costs for the three months ended June 30, 2024 and 2023 were immaterial.
NOTE
13 – SUBSEQUENT EVENTS
On
July 8, 2024 David Webster joined the company as Chief Commercial Officer (CCO). In connection with his appointment, the Company granted
an inducement stock option award (the “Inducement Option”) to Mr. Webster upon his entering into employment with the Company
in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4) (the “Inducement Award”). The Inducement Option is being granted
effective as of July 8, 2024 and is exercisable for the purchase of 125,000 shares of the Company’s common stock, at an exercise
price equal to the last reported sale price on Nasdaq on July 8, 2024. The Inducement Award was approved by the independent compensation
committee of the Board in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). The Inducement Option has a ten-year term and
will vest over a four-year period, with 25% of the shares underlying the stock option award vesting on the first anniversary of the date
of grant and annually thereafter in three equal installments, subject to Mr. Webster’s continued service with the Company through
the applicable vesting dates. The Inducement Award is subject to the terms and conditions of the Company’s 2013 Equity Incentive
Plan.
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.” We intend 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 phase 1 clinical trials.
On
November 4, 2021, we reorganized our oncology business into a new private company called Beyond Cancer. Our 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”). 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 in 2025. Beyond Air has formed a wholly owned subsidiary called NeuroNOS
which is responsible for pre-clinical and clinical development.
LungFit®
PH is the first FDA-approved system using our patented plasma pulse 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
submitted a PMA supplement to the FDA in November 2023 for the expansion of the label to include certain cardiac surgeries and we
expect to receive CE mark under the Medical Device Regulation (“MDR”) in the EU during the second half of calendar 2024.
According to the most recent year-end report from Mallinckrodt Pharmaceuticals (“Mallinckrodt”), sales of NO were $303.2
million in 2023 (down from $339.7 million in 2022) 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 addressable U.S. market for LungFit® PH to be approximately $350 million and worldwide to be
approximately $700 million. We initiated the first phase of our commercial launch (the limited launch phase to introduce Lungfit PH
and Beyond Air to hospitals) in July 2022, and entered into phase 2 (to target initial market share gains in certain geographies)
with an expanded commercial presence during the spring of 2023 in the U.S. and will continue to work towards a potential launch in
the EU and globally in 2024 and beyond. We anticipate entering the final phase of our launch process in calendar 2025 where we intend to
equip our commercial organization to become the market leader in the U.S. in a few years.
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 7 million deaths worldwide reported as of January 2024,
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 the second half of calendar 2023 in the United States and has made the decision to pause this study pending future
funding.
Bronchiolitis
(BRO)
Bronchiolitis
is the leading cause of hospital admission in children less than 1 year of age. The incidence is estimated to be 150 million new cases
a year worldwide, with 2-3% (over 3 million) of 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.
Current
estimates place the number of people with NTM infections in the U.S as high as 220,000. It is estimated that 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 2026 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 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 Company’s 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.
In
June 2024 at the American Society of Clinical Oncology (ASCO), the Company presented single agent treatment in relapsed or refractory
unresectable, primary or metastatic cutaneous and subcutaneous malignancies at UNO doses of 25,000 and 50,000 parts per million. The
immune biomarker data at Day 21, following a single 5 minute dose of UNO 50,000 ppm, demonstrated increases in dendritic cells, cytotoxic
T-cells, central memory T-cells and a favorable increase in the M1/M2 ratio. Myeloid Derived Suppressor Cells (MDSCs) also showed a 54%
decrease. In the 25,000 ppm cohort, the same stimulatory immune biomarkers were upregulated. UNO was generally well tolerated with primarily
Grade 1 related toxicities. One Grade 3 adverse event was deemed a dose limiting toxicity in the 50,000 ppm cohort resulting in the expansion
of the cohort to six total subjects.
The
Company also reported a case of relapsed/refractory Triple Negative Breast Cancer (TNBC) in which the subject showed no evidence of malignancy
in a satellite lesion 21 days following UNO treatment and a corollary, rapid and durable clinical resolution of radiation-induced dermatitis.
A
Phase 1b trial protocol has been submitted to the Israeli Ministry of Health (IMOH) and upon regulatory approval, this trial will enroll
up to 20 subjects with prior exposure to anti-PD-1 antibody that have either progressed, not achieved a response, or have prolonged stable
disease ( 12 weeks) on single agent anti-PD-1 without radiographic evidence of continued tumor reduction. Subjects enrolled in the Phase
1b trial will be treated with the UNO + anti-PD-1 combination.
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 prior to the end of 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 U.S. GAAP, and all applicable U.S. GAAP accounting
standards effective as of June 30, 2024, 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 months ended June 30, 2024 and June 30, 2023:
(in
thousands)
| |
For the Three Months Ended | |
| |
June 30, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Revenues | |
$ | 683 | | |
$ | 59 | |
| |
| | | |
| | |
Cost of revenues | |
| (1,016 | ) | |
| (303 | ) |
| |
| | | |
| | |
Gross loss | |
| (332 | ) | |
| (244 | ) |
| |
| | | |
| | |
Research and development | |
| (6,009 | ) | |
| (4,695 | ) |
Selling, general and administrative | |
| (7,239 | ) | |
| (10,936 | ) |
Operating expenses | |
| (13,247 | ) | |
| (15,631 | ) |
| |
| | | |
| | |
Operating loss | |
| (13,580 | ) | |
| (15,875 | ) |
| |
| | | |
| | |
Other income (loss) | |
| | | |
| | |
Dividend /interest income and gains on marketable securities | |
| 361 | | |
| 409 | |
Interest Expense | |
| (964 | ) | |
| (158 | ) |
Change in fair value of warrant liability | |
| 219 | | |
| 324 | |
Change in fair value of derivative liability | |
| 1,058 | | |
| 512 | |
Foreign Exchange gain/loss | |
| (146 | ) | |
| 8 | |
Estimated liability for contingent loss | |
| - | | |
| (198 | ) |
Other income / (expense) | |
| (2 | ) | |
| (77 | ) |
Total other income/(expense) | |
| 525 | | |
| 820 | |
| |
| | | |
| | |
Benefit from income taxes | |
| - | | |
| - | |
| |
| | | |
| | |
Net loss | |
$ | (13,055 | ) | |
$ | (15,055 | ) |
| |
| | | |
| | |
Less: net loss attributable to non-controlling interest | |
| (854 | ) | |
| (960 | ) |
| |
| | | |
| | |
Net loss attributable to Beyond Air, Inc. Stockholders | |
$ | (12,201 | ) | |
$ | (14,095 | ) |
| |
| | | |
| | |
Foreign currency translation gain | |
| 103 | | |
| 25 | |
Comprehensive loss attributable to Beyond Air, Inc. | |
$ | (12,098 | ) | |
| (14,070 | ) |
Net basic and diluted loss per share of common stock | |
| | | |
| | |
attributable to Beyond Air, Inc. | |
$ | (0.27 | ) | |
$ | (0.45 | ) |
| |
| | | |
| | |
Weighted average number of shares outstanding, basic and diluted | |
| 45,900,821 | | |
| 31,382,986 | |
Comparison
of Three Months Ended June 30, 2024 with the Three Months Ended June 30, 2023
Revenues
and Cost of Revenues
$0.7 million
and $0.1 million revenue was recognized for the three months ended June 30, 2024 and June 30, 2023, respectively. Cost of
revenue of $1.0 million and gross losses of $0.3 million were recognized for the three months ended June 30, 2024, compared to cost
of revenue of $0.3 million and gross losses of $0.2 million for the three months ended June 30, 2023. The increase in revenue 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 Lung Fit devices built to be able to capture
future revenue.
Research
and Development Expenses
Research
and development expenses for the three months ended June 30, 2024 were $6.0 million as compared to $4.7 million for the three months
ended June 30, 2023. The increase of $1.3 million was attributed primarily to an increase in development costs in Beyond Air ($1.1
million) and Autism ($0.1 million), an increase in salaries $0.9 million ($0.3 million for Beyond Air and $0.6 million for Beyond
Cancer), offset by a decrease in stock compensation costs $0.6 million ($0.4 million in Beyond Air and $0.2 million in Beyond
Cancer) and a decrease in development costs in Cancer research ($0.3 million).
Selling,
General and Administrative Expenses
Selling,
general and administrative expenses for the three months ended June 30, 2024 and June 30, 2023 were $7.2 million and $10.9 million, respectively.
The decrease of $3.7 million was attributed primarily to a decrease in stock-based compensation $2.2 million ($1.2 million in Beyond
Air and $1.0 million in Beyond Cancer), salaries $0.4 million (Beyond Air $0.8 million offset by an increase in Beyond Cancer $0.4 million), professional
fees ($0.7 million) rent ($0.2 million), and travel expenses ($0.1 million).
Other
Income/Expense
Other
income for the three months ended June 30, 2024, and June 30, 2023 was income of $0.5 million and income of $0.8 million, respectively.
The $0.3 million decrease in income is mainly due to increased interest payable ($0.8 million), increased foreign exchange loss ($0.1
million), a change in fair value of warrant liability ($0.1 million), offset by a change in the derivative liability of $0.5 million
on the Loan and Security Agreement (as defined below) and a reduction in contingent losses ($0.2m).
Net
Loss Attributable to Non-controlling Interest
Net
loss attributed to non-controlling interest for the three months ended June 30, 2024, was $0.9 million, compared to $1.0 million for
the three months ended June 30, 2023. Non-controlling interests represent 20% of the net loss of our Beyond Cancer majority-owned affiliate
and the increase in net loss is reflective of the increase in spend in Beyond Cancer versus the prior year.
Net
Loss Attributed to Common Stockholders
Net
loss attributed to common stockholders for the three months ended June 30, 2024, was $12.2 million or a loss of $0.27 per share,
basic and diluted. Our net loss attributed to common stockholders for the three months ended June 30, 2023 was $14.1 million or a loss
of $0.45 per share, basic and diluted.
Liquidity
and Capital Resources
Cash
Flows
Below
is a summary of the Company’s cash flows activities for the three months ended June 30, 2024 and June 30, 2023:
| |
Three Months Ended | |
| |
June 30, | |
(in thousands) | |
2024 | | |
2023 | |
| |
| | |
| |
Net cash provided by (used in): | |
| | | |
| | |
Operating activities | |
$ | (10,180 | ) | |
$ | (17,153 | ) |
Investing activities | |
| 3,114 | | |
| (9,653 | ) |
Financing activities | |
| (264 | ) | |
| (21,567 | ) |
Effect of exchange rate changes on cash and cash equivalents | |
| 111 | | |
| 40 | |
Net increase (decrease) in cash, cash equivalents and restricted cash | |
$ | (7,218 | ) | |
$ | (5,199 | ) |
Operating
Activities
For
the three months ended June 30, 2024, the net cash used in operating activities was $10.2 million which was primarily due to the Company’s
net loss before adjustment for non-cash items of $13.1 million and stock compensation costs of $3.4 million.
For
the three months ended June 30, 2023, the net cash used in operating activities was $17.2 million which was primarily due to the Company’s
net loss adjusted for non-cash items of $9.4 million, and a decrease of $7.2 million due to a one-time payment of $7.6 million attributable
to the resolution of Empery Asset Master, Ltd. Et AL, vs AIT Therapeutics Inc.
Investing
Activities
For
the three months ended June 30, 2024, net cash provided by investing activities was $3.1 million which was mainly attributable to a
net redemption of investments in marketable securities of $5.8 million and for the purchase of property and equipment of $2.7
million. For the three months ended June 30, 2023, net cash used in investing activities was $9.7 million, which was mainly
attributable to an increase in investments in marketable securities of $9.7 million and for the purchase of property and equipment
of $0.8 million.
Financing
Activities
Net
cash used by financing activities for the three months ended June 30, 2024 was $0.3 million, which were wholly comprised of loan
repayments. Net cash provided by financing
activities for the three months ended June 30, 2023 was $21.6 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 ATM of $6.0 million partially offset by $0.3
million from the payment of short-term loans.
Future
Funding Requirements
We
have generated revenue of $1.9 million from the sale of products to date. We had an operating cash flow decrease of $7.2 million for
the three months ended June 30, 2024 and we have experienced an accumulated loss of $252 million since inception through June 30, 2024.
As of June 30, 2024, we had cash, cash equivalents and marketable securities of $21.4 million ($13.2 million excluding Beyond Cancer)
and $0.2 million in restricted cash.
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, the Company and Circassia Limited and its affiliates (collectively “Circassia”) entered into a settlement
agreement (“the Settlement Agreement”) resolving all claims by and between the parties and mutually terminating the
agreement with Circassia disclosed in Note 8 above. Pursuant to the terms of the Settlement Agreement, the Company agreed to pay Circassia $10.5
million in three installments. The first payment of $2.5 million was triggered upon FDA approval for the LungFit®
PH (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. $4.5 million is included in accrued liabilities at June 30, 2024 and 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 June 30, 2024, there was a balance of $32.9 million available under the 2022 ATM.
On June 15, 2023 (the “Closing Date”), the Company and its
wholly owned subsidiary, Beyond Air Ltd. entered into a Loan and Security Agreement (the “LSA”) 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”). Also on June 15, 2023, the Company entered into a Supplement to the LSA
(collectively with the Agreement, the “Loan Agreement”) with the Agent and the Lenders for senior secured term
loans in an aggregate principal amount of up to $40.0 million, with (i) $17.5 million advanced on the Closing Date, (ii) up to $10.0
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 and an additional final payment of $0.8 million is also due upon
repayment of the principal.
We
are subject to a financial covenant requiring us to maintain $5.0 million in unrestricted cash on deposit in a US bank. 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.
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 June 30, 2024.
Changes
in Internal Control Over Financial Reporting
During
the three months ended June 30, 2024, 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
None.
ITEM
1A. Risk Factors
There
have been no material changes to the risk factors previously disclosed in Part I, “Item 1A. Risk Factors” of our 2024 Annual
Report.
ITEM
2. Unregistered Sales of Equity Securities and Use of Proceeds
On
June 21, 2024 in connection with our amendment of the Loan Agreement with the Agent and Lenders, the Company issued to each of Avenue
and Avenue 2 warrants to purchase up to 40,000 and 60,000 shares, respectively, of common stock. The Warrants expire on June 30, 2029
and have an exercise price per share of $1.28, subject to further adjustments in accordance with the terms of the warrants. The
warrants and the shares of common stock issuable upon exercise thereof were offered and sold without registration under the Securities
Act of 1933, as amended (the “Securities Act”), pursuant to the exemption provided by Section 4(a)(2) of the Securities Act
and Rule 506 promulgated thereunder as transactions not involving a public offering, as well as similar exemptions under applicable state
securities laws.
ITEM
3. Defaults Upon Senior Securities
None.
ITEM
4. Mine Safety Disclosures
Not
Applicable.
ITEM
5. Other Information
None.
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. |
|
|
|
3.4 |
|
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. |
|
|
|
4.8 |
|
Form of Common Stock Purchase Warrant, by and between Beyond Air, Inc. and the Holders party thereto, filed as Exhibit 4.1 to our Current Report on Form 8-K, filed with the SEC on March 22, 2024 and incorporated herein by reference. |
|
|
|
4.9 |
|
Form of Common Stock Purchase Warrant, by and between Beyond Air, Inc. and Avenue Venture Opportunities Fund, L.P., dated as of June 21, 2024, filed as Exhibit 4.1 to our Current Report on Form 8-K, filed with the SEC on June 27, 2024 and incorporated herein by reference. |
|
|
|
4.10 |
|
Form of Common Stock Purchase Warrant, by and between Beyond Air, Inc. and Avenue Venture Opportunities Fund II, L.P., dated as of June 21, 2024, filed as Exhibit 4.2 to our Current Report on Form 8-K, filed with the SEC on June 27, 2024 and incorporated herein by reference. |
|
|
|
10.1 |
|
Loan and Security Agreement, by and among Beyond Air, Inc., Beyond Air Ltd., Avenue Capital Management II, L.P., as Agent, and the Lenders party thereto, dated as of June 15, 2023, filed as Exhibit 10.1 to our Current Report on Form 8-K, as filed with the SEC on June 20, 2023, and incorporated herein by reference. |
|
|
|
10.2 |
|
Supplement to the Loan and Security Agreement, by and among Beyond Air, Inc., Avenue Capital Management II, L.P., as Agent, and the Lenders party thereto, dated as of June 15, 2023, filed as Exhibit 10.2 to our Current Report on Form 8-K, as filed with the SEC on June 20, 2023, and incorporated herein by reference. |
|
|
|
10.3 |
|
First Amendment to Loan Documents, by and among Beyond Air, Inc., Beyond Air Ltd., Avenue Capital Management II, L.P., as Agent, and the Lenders party thereto, dated as of June 21, 2024, filed as Exhibit 10.1 to our Current Report on Form 8-K, filed with the SEC on June 27, 2024 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:
August 6, 2024 |
Steven
Lisi |
|
President
and Chief Executive Officer |
|
(Principal
Executive Officer) |
|
|
|
/s/
Douglas Larson |
Date:
August 6, 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 its 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 13(a)-15(f) and 15(d)-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 any transitional 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:
August 6, 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 its 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 13(a)-15(f) and 15(d)-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:
August 6, 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 its subsidiaries for the period ended June 30,
2024 (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. |
|
/s/
Steven Lisi |
|
Steven
Lisi |
|
President
and Chief Executive Officer |
|
(Principal
Executive Officer) |
August
6, 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 its subsidiaries for the period ended June 30,
2024 (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) |
August
6, 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.
v3.24.2.u1
Cover - $ / shares
|
3 Months Ended |
|
Jun. 30, 2024 |
Aug. 02, 2024 |
Cover [Abstract] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Jun. 30, 2024
|
|
Document Fiscal Period Focus |
Q1
|
|
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
|
|
Entity Shell Company |
false
|
|
Entity Common Stock, Shares Outstanding |
|
46,520,515
|
Entity Listing, Par Value Per Share |
$ 0.0001
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v3.24.2.u1
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands |
Jun. 30, 2024 |
Mar. 31, 2024 |
Current Assets |
|
|
Cash and cash equivalents |
$ 4,161
|
$ 11,378
|
Marketable securities |
17,213
|
23,090
|
Restricted cash |
229
|
230
|
Accounts receivable |
475
|
319
|
Inventory |
2,391
|
2,127
|
Other current assets and prepaid expenses |
6,405
|
6,792
|
Total current assets |
30,874
|
43,936
|
Licensed right to use technology |
1,376
|
1,427
|
Right-of-use lease assets |
2,021
|
2,121
|
Property and equipment, net |
12,117
|
9,364
|
Other assets |
112
|
113
|
TOTAL ASSETS |
46,500
|
56,961
|
Current liabilities |
|
|
Accounts payable |
3,114
|
1,948
|
Accrued expenses and other current liabilities |
7,674
|
8,402
|
Operating lease liability, current portion |
429
|
418
|
Loans payable, current portion |
536
|
800
|
Total current liabilities |
11,753
|
11,567
|
Operating lease liability, net |
1,790
|
1,898
|
Long-term debt, net |
14,946
|
14,721
|
Warrant liability |
56
|
275
|
Derivative liability |
256
|
1,314
|
Total liabilities |
28,801
|
29,775
|
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, 45,900,821 shares issued and outstanding as of June 30, 2024 and March 31, 2024, respectively |
5
|
5
|
Treasury stock |
(25)
|
(25)
|
Additional paid-in capital |
267,960
|
264,780
|
Accumulated deficit |
(251,898)
|
(239,697)
|
Accumulated other comprehensive income (loss) |
88
|
(15)
|
Total stockholders’ equity attributable to Beyond Air, Inc. |
16,130
|
25,048
|
Non-controlling interest |
1,570
|
2,138
|
Total equity |
17,699
|
27,186
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ 46,500
|
$ 56,961
|
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v3.24.2.u1
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Mar. 31, 2024 |
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 |
45,900,821
|
45,900,821
|
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45,900,821
|
45,900,821
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.2.u1
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
Revenues |
$ 683
|
$ 59
|
Cost of revenues |
(1,016)
|
(303)
|
Gross loss |
(332)
|
(244)
|
Operating expenses: |
|
|
Research and development |
(6,009)
|
(4,695)
|
Selling, general and administrative |
(7,239)
|
(10,936)
|
Total operating expenses |
(13,247)
|
(15,631)
|
Loss from operations |
(13,580)
|
(15,875)
|
Other income (expense) |
|
|
Dividend and interest income |
361
|
409
|
Interest and finance expense |
(964)
|
(158)
|
Change in fair value of warrant liability |
219
|
324
|
Change in fair value of derivative liability |
1,058
|
512
|
Foreign exchange gain / (loss) |
(146)
|
8
|
Estimated liability for contingent loss |
|
(198)
|
Other income / (expense) |
(2)
|
(77)
|
Total other income/(expense) |
525
|
820
|
Net loss before income taxes |
(13,055)
|
(15,055)
|
Provision for income taxes |
|
|
Net loss |
(13,055)
|
(15,055)
|
Less : net loss attributable to non-controlling interest |
(854)
|
(960)
|
Net loss attributable to Beyond Air, Inc. |
(12,201)
|
(14,095)
|
Foreign currency translation gain |
103
|
25
|
Comprehensive loss attributable to Beyond Air, Inc. |
$ (12,098)
|
$ (14,070)
|
Net basic loss per share attributable to Beyond Air, Inc. |
$ (0.27)
|
$ (0.45)
|
Net diluted loss per share attributable to Beyond Air, Inc. |
$ (0.27)
|
$ (0.45)
|
Weighted average number of shares, outstanding basic |
45,900,821
|
31,382,986
|
Weighted average number of shares, outstanding diluted |
45,900,821
|
31,382,986
|
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v3.24.2.u1
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, 2023 |
$ 3
|
$ (25)
|
$ 217,339
|
$ (179,455)
|
$ 53
|
$ 4,113
|
$ 42,028
|
Balance, shares at Mar. 31, 2023 |
30,738,585
|
|
|
|
|
|
|
Stock-based compensation |
|
|
5,580
|
|
|
535
|
6,115
|
Other comprehensive income |
|
|
|
|
25
|
|
25
|
Net loss |
|
|
|
(14,095)
|
|
(960)
|
(15,055)
|
Issuance of common stock upon exercise of options |
|
|
217
|
|
|
|
217
|
Issuance of common stock upon exercise of options, shares |
42,500
|
|
|
|
|
|
|
At the market equity offering stock issuance of common stock, net |
|
|
5,813
|
|
|
|
5,813
|
At the market equity offering stock issuance of common stock, net, shares |
930,232
|
|
|
|
|
|
|
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, 2024 |
$ 5
|
(25)
|
264,780
|
(239,697)
|
(15)
|
2,138
|
27,186
|
Balance, shares at Mar. 31, 2024 |
45,900,821
|
|
|
|
|
|
|
Issuance of common stock warrants |
|
|
86
|
|
|
|
86
|
Stock-based compensation |
|
|
3,093
|
|
|
285
|
3,379
|
Other comprehensive income |
|
|
|
|
103
|
|
103
|
Net loss |
|
|
|
(12,201)
|
|
(854)
|
(13,055)
|
Balance at Jun. 30, 2024 |
$ 5
|
$ (25)
|
$ 267,960
|
$ (251,898)
|
$ 88
|
$ 1,570
|
$ 17,699
|
Balance, shares at Jun. 30, 2024 |
45,900,821
|
|
|
|
|
|
|
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v3.24.2.u1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Mar. 31, 2024 |
Cash flows from operating activities |
|
|
|
Net loss |
$ (13,055)
|
$ (15,055)
|
|
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
|
Depreciation and amortization |
685
|
309
|
|
Amortization of licensed right to use technology |
51
|
52
|
|
Stock-based compensation |
3,379
|
6,115
|
|
Amortization of debt discount |
409
|
57
|
|
Change in fair value of warrant liability |
(219)
|
(324)
|
|
Change in fair value of derivative liability |
(1,058)
|
(512)
|
|
Amortization of operating lease assets |
94
|
90
|
|
Un-realized gain in marketable securities |
90
|
(75)
|
$ 123
|
Foreign currency adjustments |
|
(8)
|
|
Changes in: |
|
|
|
Grant receivable |
|
(5)
|
|
Inventory |
(338)
|
(209)
|
|
Accounts receivable |
(156)
|
(44)
|
|
Other current assets and prepaid expenses |
391
|
74
|
|
Accounts payable |
491
|
(306)
|
|
Accrued expenses |
(848)
|
(7,228)
|
|
Operating lease liabilities |
(97)
|
(84)
|
|
Net cash used in operating activities |
(10,180)
|
(17,153)
|
|
Cash flows from investing activities |
|
|
|
Purchase of marketable securities |
(14,574)
|
(9,744)
|
|
Proceeds from sale of marketable securities |
20,361
|
886
|
|
Purchase of property and equipment |
(2,673)
|
(795)
|
|
Net cash provided by and (used in) investing activities |
3,114
|
(9,653)
|
|
Cash flows from financing activities |
|
|
|
Proceeds from issuance of common stock through at the market offerings |
|
5,814
|
|
Proceeds from issuance of common stock through exercise of stock options |
|
217
|
|
Proceeds from loan |
|
15,817
|
|
Payment of loan |
(264)
|
(280)
|
|
Net cash (used in) and provided by financing activities |
(264)
|
21,567
|
|
Effect of exchange rate changes on cash and cash equivalents |
111
|
40
|
|
Decrease in cash, cash equivalents and restricted cash |
(7,218)
|
(5,199)
|
|
Cash, cash equivalents and restricted cash at beginning of period |
11,608
|
36,768
|
36,768
|
Cash, cash equivalents and restricted cash at end of period |
4,390
|
31,569
|
$ 11,608
|
Supplemental disclosure of non-cash investing and financing activities |
|
|
|
Debt discount |
621
|
4,541
|
|
End of term loan liability |
(438)
|
(613)
|
|
Warrant liability |
|
(885)
|
|
Derivative liability |
|
(1,361)
|
|
Fixed assets recorded in accounts payable and accrued assets |
749
|
|
|
Supplemental disclosure of cash flow items: |
|
|
|
Interest paid |
556
|
289
|
|
Income taxes paid |
|
|
|
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v3.24.2.u1
ORGANIZATION AND BUSINESS
|
3 Months Ended |
Jun. 30, 2024 |
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 phase 1 human clinical trials.
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 the end of 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 ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
|
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v3.24.2.u1
SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES
|
3 Months Ended |
Jun. 30, 2024 |
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 June 30, 2024 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, 2024 (the “2024
Annual Report”), filed with the U.S. Securities and Exchange Commission (the “SEC”) on June 24, 2024. 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 2024 Annual Report on Form 10-K.
Principles
of Consolidation
These
unaudited condensed consolidated financial statements include the accounts of the Company and the accounts of all of the
Company’s subsidiaries 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 result 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 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. Of the restricted cash originally recorded
in the unaudited condensed consolidated statement of cash flows for the three months ended June 30, 2023, $2.5 million has been reclassified
and is now recorded in prepaid assets. These reclassifications had no effect on the reported results of operations.
Use
of Estimates
The
preparation of financial statements in conformity with generally accepted accounting principles in the United States (“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 significantly differ from those estimates. On an ongoing basis, the Company evaluates its significant estimates
and assumptions including expense recognition and accrual assumptions under consulting and clinical trial agreements, stock-based compensation,
impairment assessments, accounting for licensed rights to use technologies and other long-lived assets, contingency recognition and accruals
and the determination of valuation allowance requirements on deferred tax attributes.
Going
Concern, Liquidity and Other Uncertainties
The
Company used cash in operating activities of $10.2 million for the three months ended June 30, 2024, and has accumulated losses attributable
to the stockholders of Beyond Air of $251.9 million. The Company had cash, cash equivalents and marketable securities of $21.4 million
as of June 30, 2024.
The
Company expects to incur net losses and have significant cash outflows for at least the next year, 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 the Company to meet its obligations.
Management
currently has various funding options in place to raise additional capital such as a debt line of $12.5 million with Avenue (as defined below) and its affiliates,
subject to the agent and lenders receiving investment committee approval and negotiations of the terms and conditions between both parties, (Note 11),
an ATM sales agreement with $32.9 million of available funds (Note 4), assets that can be leveraged such as Beyond Cancer, Autism, LungFit
PH international partnerships, LungFit PRO international partnerships and LungFit GO partnerships. Additionally, in January 2022 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. The securities purchase agreement entered into in March 2024 contains restrictions to the Company’s
ability to enter into variable rate transactions for a period of 6 months.
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. A combination study with anti-PD1 therapy is expected to begin before the
end of calendar 2024.
The
Company’s future capital needs and the adequacy of its available funds will depend on many factors, including, but not necessarily
limited to the success and costs of commercialization of the Company’s approved product and the actual cost and time necessary
for current and anticipated preclinical studies, clinical trials and other actions needed to obtain certification or regulatory approval
of the Company’s product candidates.
The
Company will be required to raise additional funds through equity or debt securities offerings or strategic collaboration and/or licensing
agreements in order to fund operations if it is unable to generate enough product or royalty revenues, if any. Such financing may not
be available on acceptable terms, or at all, and the Company’s failure to raise capital when needed could have a material adverse
effect on its strategic objectives, results of operations and financial condition.
The accompanying unaudited 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 ITS 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.
Lease
Revenue Recognition
The
Company generates revenue from the leases of its LungFit® PH devices to its customers under fixed fee arrangements over periods of
up to three years. The fixed fee is typically broken down into ratable monthly payments over the term of the arrangement. The Company’s
customers include hospitals and medical facilities. The Company’s LungFit® PH leases include filters, calibration gas, bagging
kits, cables, adapters, and other components and accessories required to use the LungFit® PH device (the “Consumables”).
The Consumables’ quantities are varied and may be supplied upon demand of the customers and are unlimited, or the arrangement may
provide for the maximum quantities available to the customer over the term of the arrangement. The Company’s LungFit® PH leases
also include maintenance and training required to use the LungFit® PH device, as well as device back-up services (the “Services”),
which are recorded in cost of revenue.
The
Company accounts for its rental arrangements of LungFit® PH devices in accordance with Accounting Standards Codification 842, Leases
(“ASC 842”). Under ASC 842, leases may be classified as either financing, sales-type, or operating, and the Company is required
to disclose key information about leasing arrangements. The classification determines the pattern of revenue recognition and classification
within the statement of operations and comprehensive loss. The Company typically classifies the rental arrangement of its LungFit®
PH contracts as operating leases. The Company’s leases do not contain any restrictive covenants or any material residual value
guarantees. The Company’s equipment leases may contain renewal options which range from one month to two years. The lease term
is adjusted for renewal or termination options that the Company believe the customer is reasonably certain to exercise.
The
Company elected the practical expedient applied to operating leases not to separate lease and non-lease components as long as the lease
and at non-lease components have the same timing and pattern of transfer. As such, the non-lease components, including the Consumables
and Services, are combined with the predominant lease component. The total fixed fees that the Company is reasonably certain to collect
are recognized on a straight line basis over the term of the arrangement. Additionally, the Company made an accounting policy election
to present LungFit® PH revenue net of sales and other similar taxes.
Amounts
billed in advance of performance obligations being satisfied are recognized as deferred revenue.
At
the lease commencement date, the Company will defer initial direct costs, including commission expense and the cost is recognized over
the lease term on the same basis as lease income.
The
Company records the costs of shipping related to contract devices and consumables in cost of revenue in its consolidated statements of
operations.
See
Note 12 to the unaudited condensed consolidated financial statements for more information regarding leasing arrangements.
Fair
Value Measurements
As
of June 30, 2024 and March 31, 2024, the Company’s financial instruments included restricted cash, marketable securities, accounts
payable, long-term debt, liability classified warrants and derivative liabilities. The carrying amounts reported in the accompanying
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 ITS 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 at June 30, 2024 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 | |
| 17,213 | | |
| 17,213 | | |
| - | | |
| - | |
Mutual funds | |
| - | | |
| - | | |
| - | | |
| - | |
Total assets measured and recorded at fair value | |
$ | 17,213 | | |
$ | 17,213 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities : | |
| | | |
| | | |
| | | |
| | |
Warrant liability | |
$ | 56 | | |
$ | - | | |
$ | - | | |
$ | 56 | |
Derivative liability | |
| 256 | | |
| - | | |
| - | | |
| 256 | |
Total liabilities measured and recorded at fair value | |
$ | 312 | | |
$ | 0 | | |
$ | - | | |
$ | 312 | |
The
fair value amounts at March 31, 2024 are:
(in thousands) | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Marketable securities : | |
| | | |
| | | |
| | | |
| | |
Corporate debt securities | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
Government securities | |
| 16,388 | | |
| 16,388 | | |
| - | | |
| - | |
Mutual funds | |
| 6,702 | | |
| 6,702 | | |
| - | | |
| - | |
Total assets measured and recorded at fair value | |
$ | 23,090 | | |
$ | 23,090 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities : | |
| | | |
| | | |
| | | |
| | |
Warrant liability | |
$ | 275 | | |
$ | - | | |
$ | - | | |
$ | 275 | |
Derivative liability | |
| 1,314 | | |
| - | | |
| - | | |
| 1,314 | |
Total liabilities measured and recorded at fair value | |
$ | 1,589 | | |
$ | - | | |
$ | - | | |
$ | 1,589 | |
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)
Level
3 Valuation
The
common stock warrants issued in connection with the Loan and Security Agreement in June 2023 (Note 11) are recorded as a warrant
liability within the unaudited condensed consolidated balance sheet at June 30, 2024 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
At June 30, 2024 | |
Warrants | | |
Derivative | |
Expected term (in years) | |
| 4 | | |
| 3 | |
Volatility | |
| 90 | % | |
| 90 | % |
Risk-free rate | |
| 4.24 | % | |
| 4.52 | % |
At March 31, 2024 | |
Warrants | | |
Derivative | |
Expected term (in years) | |
| 4.25 | | |
| 3.25 | |
Volatility | |
| 88 | % | |
| 86 | % |
Risk-free rate | |
| 4.09 | % | |
| 4.38 | % |
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 three months ended June 30, 2024 (in thousands):
SCHEDULE
OF CHANGES IN FAIR VALUE OF WARRANTS AND DERIVATIVES
| |
Warrants | | |
Derivative | |
Balance at March 31,2024 | |
$ | 275 | | |
$ | 1,314 | |
Issuances | |
| - | | |
| - | |
Change in fair value | |
| (219 | ) | |
| (1,058 | ) |
Balance at June 30, 2024 | |
$ | 56 | | |
$ | 256 | |
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 investments 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 June 30, 2024 and March 31, 2024, restricted cash included approximately $0.2 million and $0.2 million, respectively.
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentrations of credit risk consist of cash accounts in a financial institution,
which at times, may exceed the federal depository insurance coverage of $250,000 in the United States, A$250,000 in Australia, $25,000
in Bermuda, €100,000 in Ireland and €100,000 in Cyprus. There is currently no official federal depository insurance in Israel.
The Company has not experienced losses on these accounts, and management believes the Company is not exposed to significant risks on
such accounts. As of June 30, 2024, the Company had greater than $250,000 at United States financial institutions, greater than A$250,000
at Australian financial institutions, greater than €100,000 at Irish financial institutions and also has funds on deposit in Israel.
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, MARKETABLE SECURITIES AND RESTRICTED CASH
(in thousands) | |
June 30, 2024 | | |
March 31, 2024 | |
Cash and cash equivalents | |
$ | 4,161 | | |
$ | 11,378 | |
Restricted cash | |
| 229 | | |
| 230 | |
Total cash, cash equivalents and restricted cash | |
$ | 4,390 | | |
$ | 11,608 | |
Marketable securities: | |
| | | |
| | |
Marketable debt securities | |
| - | | |
| - | |
Corporate debt securities | |
$ | - | | |
$ | - | |
U.S. government securities | |
| 17,213 | | |
| 16,388 | |
Mutual fund (ultra-short-term income) | |
| - | | |
| 6,702 | |
Total marketable securities | |
$ | 17,213 | | |
$ | 23,090 | |
| |
| | | |
| | |
Total cash, cash equivalents, marketable securities and restricted cash | |
$ | 21,603 | | |
$ | 34,698 | |
The
following table summarizes our short-term marketable securities with unrealized gains and losses as of June 30, 2024, 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 | |
| 17,213 | | |
| 90 | |
Mutual fund (ultra-short-term income) | |
| - | | |
| - | |
Total short-term marketable securities | |
$ | 17,213 | | |
$ | 90 | |
The
following table summarizes our short-term marketable securities with unrealized gains and losses as of March 31, 2024, aggregated by
major security type:
(in thousands) | |
Fair Value | | |
Unrealized Gains and (Losses) | |
Corporate debt securities | |
$ | - | | |
$ | - | |
U.S. government securities | |
| 16,388 | | |
| 117 | |
Mutual fund (ultra-short-term income) | |
| 6,702 | | |
| 6 | |
Total short-term marketable securities | |
$ | 23,090 | | |
$ | 123 | |
All
marketable securities are A- or higher rated. No marketable securities have maturities greater than 12 months. All investments are level
1 investments.
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)
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 June 30, 2024,
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 at June 30, 2024:
SCHEDULE
OF SEGMENT FINANCIAL INFORMATION BY BUSINESS SEGMENT
(in thousands) | |
Beyond Air | | |
Beyond Cancer | | |
Total | |
Cash, cash equivalents, marketable securities and certain restricted cash | |
$ | 13,371 | | |
$ | 8,230 | | |
$ | 21,603 | |
All other assets | |
| 24,144 | | |
| 755 | | |
| 24,897 | |
Total assets | |
$ | 37,515 | | |
$ | 8,985 | | |
$ | 46,500 | |
Total liabilities | |
$ | (27,722 | ) | |
$ | (1,078 | ) | |
$ | (28,801 | ) |
Net assets | |
$ | 9,793 | | |
$ | 7,907 | | |
$ | 17,699 | |
Non-controlling interests | |
$ | - | | |
$ | 1,570 | | |
$ | 1,570 | |
The
following table summarizes segment financial information by business segment at March 31, 2024:
(in thousands) | |
Beyond Air | | |
Beyond Cancer | | |
Total | |
Cash, cash equivalents, marketable securities and certain restricted cash | |
$ | 23,591 | | |
$ | 10,877 | | |
$ | 34,468 | |
All other assets | |
| 21,747 | | |
| 746 | | |
| 22,493 | |
Total assets | |
$ | 45,338 | | |
$ | 11,623 | | |
$ | 56,961 | |
Total liabilities | |
$ | (28,810 | ) | |
$ | (965 | ) | |
$ | (29,775 | ) |
Net assets | |
$ | 16,528 | | |
$ | 10,658 | | |
$ | 27,186 | |
Non-controlling interests | |
$ | - | | |
$ | 2,138 | | |
$ | 2,138 | |
The
following table summarizes segment financial performance by business segment for the three months ended June 30, 2024:
(in thousands) | |
Beyond Air | | |
Beyond Cancer | | |
Total | |
Revenue | |
$ | 683 | | |
$ | - | | |
$ | 683 | |
Net loss for the three months ended June 30, 2024 | |
$ | (8,786 | ) | |
$ | (4,269 | ) | |
$ | (13,055 | ) |
The
following table summarizes segment financial performance by business segment for the three months ended June 30, 2023:
(in thousands) | |
Beyond Air | | |
Beyond Cancer | | |
Total | |
| |
| | |
| | |
| |
Revenue | |
$ | 59 | | |
$ | - | | |
$ | 59 | |
Net loss for the three months ended June 30, 2023 | |
$ | (10,256 | ) | |
$ | (4,799 | ) | |
$ | (15,055 | ) |
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)
Research
and Development
Research
and development expenses are charged to the unaudited 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 June 30, 2024 and
June 30, 2023, the Company did not
receive any AU Tax Rebates.
Supplier
Concentration
The
Company relies on third-party suppliers to provide materials for its devices and consumables. In the three months ended June 30, 2024,
the Company purchased approximately 87% of its materials from one third party vendor. In the three months ended June 30, 2023, the Company
purchased approximately 84% of its materials from two third-party vendors, with these vendors representing 65% and 19%, respectively.
Leases
Operating
lease assets are included within operating lease right-of-use assets, and the corresponding operating lease obligation on the consolidated
balance sheets as of June 30, 2024 and March 31, 2024 in accordance with ASC 842, Leases. The Company has elected not to present
short-term leases as these leases have a lease term of 12 months or less at lease inception and do not contain purchase options or renewal
terms that the Company is reasonably certain to exercise. All other lease assets and lease liabilities are recognized based on the present
value of lease payments over the lease term at commencement date. Because most of the Company’s leases do not provide an implicit
rate of return, the Company used an incremental borrowing rate based on the information available at adoption date in determining the
present value of lease payments.
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
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- DefinitionThe entire disclosure for all significant accounting policies of the reporting entity.
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v3.24.2.u1
PROPERTY AND EQUIPMENT
|
3 Months Ended |
Jun. 30, 2024 |
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) | |
June 30, 2024 | | |
March 31, 2024 | |
| |
| | |
| |
Clinical and medical equipment | |
$ | 2,174 | | |
$ | 2,174 | |
Equipment deployable as part of a service offering | |
| 11,638 | | |
| 8,208 | |
Computer equipment | |
| 855 | | |
| 860 | |
Furniture and fixtures | |
| 534 | | |
| 534 | |
Leasehold improvements | |
| 612 | | |
| 612 | |
Property
and equipment, gross | |
| 15,812 | | |
| 12,388 | |
Accumulated depreciation | |
| (3,695 | ) | |
| (3,024 | ) |
Property
and equipment, net | |
$ | 12,117 | | |
$ | 9,364 | |
Depreciation
and amortization for the three months ended June 30, 2024 and June 30, 2023 was $0.7 million and $0.3 million, respectively.
|
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.24.2.u1
STOCKHOLDERS’ EQUITY
|
3 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
STOCKHOLDERS’ EQUITY |
NOTE
4 STOCKHOLDERS’ EQUITY
On
February 4, 2022, the Company entered into an At-The-Market Equity Offering Sales Agreement with Truist Securities, Inc (the “2022 ATM”), allowing the Company to sell its common stock for aggregate sales proceeds of up to $50
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.
During
the three months ended June 30, 2024, the Company received net proceeds of $0.0
million from the sale shares of common stock
through the 2022 ATM. During the three months ended June 30, 2023, the Company received net proceeds of $5.8
million from the sale of 930,232
shares of common stock. As of June 30, 2024,
there were $32.9
million in funds available under the 2022 ATM.
On
March 20, 2024, the Company, entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain
institutional and accredited investors, including certain directors and officers of the Company, (the “Purchasers”) pursuant
to which the Company sold, in a registered direct offering, an aggregate of (i) 9,638,556 shares (the “Shares”) of common
stock and (ii) 9,638,556 common stock purchase warrants (the “common stock warrants”) to purchase up to 9,638,556 shares
of Common Stock (the “common stock warrant shares”) for gross proceeds of $16 million (which includes $1.2 million from related
parties). Members of the Board of the Directors and certain executives of the Company are considered related parties to this offering.
These warrants contain a call provision which can be exercised if the Company reports $4.5 million of net sales in the quarter ending
March 31, 2025. The combined offering price per share and accompanying common stock warrant is $1.66. Subject to certain ownership limitations,
each common stock warrant is immediately exercisable upon issuance at an exercise price of $2.25 per share and expires three years from
the date of issuance. The offering closed on March 22, 2024. The Company received net proceeds of $14.6 million after deductions for
placement agent commissions and other offering costs of $1.1 million and $0.3 million, respectively.
On
March 20, 2024, the Company also entered into a placement agency agreement (the “Placement Agency Agreement”) with Roth
Capital Partners, LLC and Laidlaw & Company (UK) Ltd. (the “Co-Placement Agents”) as the co-placement agents in
connection with the March 20, 2024 offering. Pursuant to the terms of the Placement Agency Agreement, the Co-Placement Agents agreed
to use their reasonable best efforts to arrange for the sale of the securities in the offering. As compensation to the Co-Placement
Agents, the Company paid the Co-Placement Agents a cash fee of 7%
of the aggregate gross proceeds raised in the offering and the reimbursement of certain expenses and legal fees.
In
addition, under the Securities Purchase Agreement, until 90 days after March 22, 2024, subject to certain exceptions, neither the Company
nor any of its subsidiaries were allowed to (i) issue, enter into any agreement to issue or announce the issuance or proposed issuance of any common
stock or common stock equivalents or (ii) file any registration statement or amendment or supplement thereto.
In
addition, from the date of the Securities Purchase Agreement, the Company has agreed not to enter into variable rate transactions (as
defined in the Securities Purchase Agreement) for a period of six (6) months from the closing of the offering, subject to certain exceptions.
Stock
Option Plans
The
Company’s Sixth 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 10, 2024, 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 2024 annual stockholder meeting
on March 8, 2024. The 2013 BA Plan has 13,600,000 shares authorized for issuance. As of June 30, 2024, 421,558 shares were available
under the 2013 BA Plan.
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
4 STOCKHOLDERS’ EQUITY (continued)
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 three months ended June 30, 2024 is as follows:
SCHEDULE OF RESTRICTED STOCK AWARDS
| |
Number Of Shares | | |
Weighted Average Grant Date Fair Value | |
| |
| | |
| |
Unvested as of April 1, 2024 | |
| 618,900 | | |
$ | 6.98 | |
Granted | |
| - | | |
| - | |
Vested | |
| - | | |
| - | |
Forfeited | |
| (6,000 | ) | |
| 14.36 | |
Unvested as of June 30, 2024 | |
| 612,900 | | |
$ | 6.91 | |
Stock-based
compensation expense related to these grants for the three months ended June 30, 2024 and June 30, 2023 was $0.3 million and $0.7 million,
respectively.
As
of June 30, 2024, the Company had unrecognized stock-based compensation expense for the restricted stock unit awards in the 2013 BA Plan
of approximately $1.6 million which is expected to be expensed over the weighted average remaining service period of 1.6 years.
A
summary of the change in options for the three months ended June 30, 2024 is as follows:
SCHEDULE OF 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, 2024 | | |
| 11,283,469 | | |
$ | 4.45 | | |
| 8.0 | | |
$ | 760 | |
Granted | | |
| 27,500 | | |
| 4.25 | | |
| - | | |
| - | |
Exercised | | |
| - | | |
| - | | |
| - | | |
| - | |
Forfeited | | |
| (144,125 | ) | |
| 4.94 | | |
| - | | |
| - | |
Outstanding as of June 30, 2024 | | |
| 11,166,844 | | |
$ | 4.41 | | |
| 7.76 | | |
$ | 0 | |
Exercisable as of June 30, 2024 | | |
| 4,758,469 | | |
$ | 5.44 | | |
| 5.95 | | |
$ | 0 | |
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
4 STOCKHOLDERS’ EQUITY (continued)
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 Ltd.’s common stock.
The vesting terms of the options issued under the 2021 BC Plan are generally four years and they expire ten years from the grant date.
On November 3, 2022, the Company’s Board of Directors approved an amendment to reserve for issuance an additional 2,000,000 shares
of common stock. The 2021 BC Plan has 4,000,000 shares authorized for issuance. As of June 30, 2024, 243,250 common shares were available
under the 2021 BC Plan.
SCHEDULE
OF 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, 2024 | | |
| 3,819,000 | | |
$ | 5.50 | | |
| 8.3 | | |
$ | - | |
Granted | | |
| - | | |
| - | | |
| - | | |
| - | |
Exercised | | |
| - | | |
| - | | |
| - | | |
| - | |
Forfeited | | |
| (62,250 | ) | |
| 5.50 | | |
| - | | |
| - | |
Outstanding as of June 30, 2024 | | |
| 3,756,750 | | |
$ | 5.50 | | |
| 8.0 | | |
$ | 0 | |
Exercisable as of June 30, 2024 | | |
| 1,354,000 | | |
$ | 5.50 | | |
| 7.8 | | |
$ | 0 | |
As
of June 30, 2024, the Company had unrecognized stock-based compensation expense in the 2013 BA Plan of approximately $9.0
million which is expected to be expensed over
the weighted average remaining service period of 1.8
years
As
of June 30, 2024, the Company had unrecognized stock-based compensation expense in the 2021 BC Plan of approximately $7.6 million which
is expected to be expensed over the weighted average remaining service period of 1.4 years.
The
following was utilized to calculate the fair value of options on the date of grant:
SCHEDULE OF FAIR VALUE OF OPTION
| |
June 30, 2024 | |
|
June 30, 2023 | |
Risk-free interest rate | |
| 4.3-4.5 | % |
|
| 3.5 - 3.9 | % |
Expected volatility (Beyond Air) | |
| 83.5 – 83.8 | % |
|
| 81.6-82.7 | % |
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 months ended June 30, 2024 and June 30, 2023:
SCHEDULE
OF STOCK-BASED COMPENSATION EXPENSE
|
|
2024 |
|
|
2023 |
|
|
|
Three Months Ended |
|
(in thousands) |
|
June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
629 |
|
|
$ |
1,206 |
|
General and administrative |
|
|
2,750 |
|
|
|
4,911 |
|
Total stock-based compensation expense |
|
$ |
3,379 |
|
|
$ |
6,115 |
|
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
4 STOCKHOLDERS’ EQUITY (continued)
Warrants
A
summary of the Company’s outstanding warrants as of June 30, 2024 is as follows:
SUMMARY
OF COMPANY’S OUTSTANDING WARRANTS
Warrant Holders | |
Number of Warrants | | |
Exercise Price | | |
Intrinsic Value (in thousands) | | |
Date of Expiration | |
| |
| | |
| | |
| | |
| |
March 2020 loan | |
| 172,187 | | |
$ | 7.26 | | |
$ | - | | |
| March 2025 | |
NitricGen agreement | |
| 80,000 | | |
$ | 6.90 | | |
| - | | |
| January 2028 | |
Avenue agreement | |
| 233,843 | | |
$ | 1.66 | | |
| - | | |
| June 2028 | |
March 2024 Roth/Laidlaw raise | |
| 9,638,556 | | |
$ | 2.25 | | |
| - | | |
| March 2027 | |
Avenue extension agreement | |
| 100,000 | | |
$ | 1.28 | | |
| - | | |
| June 2029 | |
Total | |
| 10,224,586 | | |
$ | 2.35 | | |
$ | - | | |
| | |
On
June 21, 2024, warrants to purchase up to an aggregate of 100,000
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 return for extending the interest-only period for an additional 6 months on the
Loan and Security Agreement with Avenue Capital. The warrant exercise price was calculated at the average closing share price for
the 5 trading days prior to June 21, 2024. No warrants were exercised in this period.
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OTHER CURRENT ASSETS AND PREPAID EXPENSES
|
3 Months Ended |
Jun. 30, 2024 |
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 is as follows (in thousands):
SCHEDULE OF CURRENT ASSETS AND PREPAID EXPENSES
| |
June 30, 2024 | | |
March 31, 2024 | |
Prepaid research and development | |
$ | 148 | | |
$ | 104 | |
Prepaid insurance | |
| 605 | | |
| 886 | |
Prepaid rents and tenant improvements | |
| 48 | | |
| 49 | |
Value added tax receivable | |
| 179 | | |
| 229 | |
Deposits to secure manufacturing materials | |
| 5,019 | | |
| 5,019 | |
Demonstration materials | |
| 145 | | |
| 228 | |
Other | |
| 261 | | |
| 277 | |
Total | |
$ | 6,405 | | |
$ | 6,792 | |
Prepaid
expenses and other current assets | |
$ | 6,405 | | |
$ | 6,792 | |
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ACCRUED EXPENSES
|
3 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
ACCRUED EXPENSES |
NOTE
6 ACCRUED EXPENSES
A
summary of the accrued expenses as of June 30, 2024 and March 31, 2024 is as follows (in thousands):
SUMMARY OF ACCRUED EXPENSES
| |
June 30, 2024 | | |
March 31, 2024 | |
Research and development | |
$ | 848 | | |
$ | 965 | |
Professional fees | |
| 575 | | |
| 466 | |
Employee salaries and benefits | |
| 1,280 | | |
| 1,302 | |
Contingent litigation and settlements (Note 10) | |
| 200 | | |
| 400 | |
Circassia settlement – current portion (Note 8) | |
| 4,500 | | |
| 4,500 | |
Deferred revenue | |
| - | | |
| 138 | |
Goods received not invoiced | |
| 130 | | |
| 356 | |
Other | |
| 141 | | |
| 275 | |
Total short-term accrued expenses | |
$ | 7,674 | | |
$ | 8,402 | |
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
|
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BASIC AND DILUTED NET INCOME (LOSS) PER SHARE OF COMMON STOCK
|
3 Months Ended |
Jun. 30, 2024 |
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
In
accordance with ASC 260, Earnings Per Share, warrants that are accounted for as liabilities which are potentially dilutive have
not been included in diluted earnings per share as they would have been anti-dilutive during the three months ended June 30, 2024.
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
| |
June 30, 2024 | | |
June 30, 2023 | |
| |
| | |
| |
Common stock warrants | |
| 10,224,586 | | |
| 694,363 | |
Common stock options | |
| 11,166,844 | | |
| 8,132,952 | |
Restricted shares | |
| 612,900 | | |
| 1,095,300 | |
Loan and Security – conversion feature (note 11) | |
| 1,390,176 | | |
| 392,465 | |
Total | |
| 23,394,506 | | |
| 10,315,080 | |
Anti-dilutive
securities | |
| 23,394,506 | | |
| 10,315,080 | |
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v3.24.2.u1
CIRCASSIA AGREEMENT
|
3 Months Ended |
Jun. 30, 2024 |
Circassia Agreement |
|
CIRCASSIA AGREEMENT |
NOTE
8 CIRCASSIA 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 installments. The first payment of $2.5 million
was triggered upon FDA approval for the LungFit® PH (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
As of June 30, 2024 and March 31, 2024 $4.5 million
is included in accrued liabilities and is payable in the second fiscal quarter of 2025.
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v3.24.2.u1
GRANT COLLABORATION AGREEMENT
|
3 Months Ended |
Jun. 30, 2024 |
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 with CFF, the funding will be
allocated to the ongoing LungFit® GO NTM pilot study. 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. For the three months ended June 30,
2024 and June 30, 2023, the Company recorded $0
and $5
thousand as a reduction to R&D expense, respectively. 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. The trial is now successfully completed and no further payments are expected.
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
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v3.24.2.u1
COMMITMENTS AND CONTINGENCIES
|
3 Months Ended |
Jun. 30, 2024 |
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 $0.5
million 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 $0.1 million upon the execution
of the NitricGen Agreement, $0.1 million 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 June 30, 2024 the remaining future milestone payments total $0.3 million.
Supply
Agreement and Purchase Order
In
August 2020, the Company entered into a supply agreement with an initial expiration date of 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. As of the date of this report, the Company has not provided such notice. The Company has opened several non-cancellable
purchase orders and the outstanding amount remaining under the purchase order as of June 30, 2024 was approximately $1.4
million with this supplier. This supplier holds $5.0
million of restricted cash to partially secure materials on the Company’s behalf recorded in other current assets and prepaid
expenses.
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.
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 the Company paid
$3.1 million for defense and indemnity costs in the quarter ended September 30, 2023.
From
time to time, we are involved in various legal matters arising in the normal course of business. We do not expect the outcome of such
proceedings, either individually or in the aggregate, to have a material effect on our financial position, cash flows or results of operations.
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
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- DefinitionThe entire disclosure for commitments and contingencies.
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v3.24.2.u1
LOANS
|
3 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
LOANS |
NOTE
11 LOANS
LOAN
AND SECURITY AGREEMENT
On
June 15, 2023 (the “Closing Date”), Beyond Air, Inc. and its wholly-owned subsidiary, Beyond Air Ltd., 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 September 30, 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 installments 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. For the quarter ended June 30, 2024 and June 30 2023 , the Company incurred and paid $0.6 million and $0 million
respectively in interest on the loan.
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 on deposit in a US bank. 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 (1,390,176
of common stock at $2.158),
for the life of the loan (“the “Conversion Right”).
On
June 21, 2024, the Company, in return for extending the interest-only period for an additional 6 months on the Loan and Security
Agreement with Avenue Capital, entered into an agreement to issue warrants to purchase up to 100,000
shares of common stock at an exercise price of $1.28
per share and an additional end of term payment of $87,500
plus legal and amendment fees, which resulted in an increase to debt discount and this increase will be amortized over the remainder
of the loan period. As the transaction did not have a substantially different impact to the terms of the original instrument, the
company determined that this transaction was a modification to the original loan and security agreement. The maturity of the debt
remains unchanged.
Upon consummation
of the offering contemplated by the Securities Purchase Agreement and in accordance
with their original terms, the 233,843 liability classified warrants issued the lenders
had their original exercise price of $5.88 per share repriced to $1.66 per share and the original conversion price of $7.64 per
share of the Conversion Right was reset to $2.16 per share. The previously issued warrants and bifurcated conversion feature have
been, and will continue to be, liability classified and remeasured at each reporting period until they are exercised, expire,
reclassified or otherwise settled. The adjustment for the exercise price has been recorded as a revaluation of warrants fair value
and revaluation of derivative fair value respectively in the statement of operations.
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.
The
agreement contains an end of term liability of $1.1
million, equal to 3.5%
of the committed funds plus an additional end of term payment of $0.1 million.
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
11 LOANS (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) | |
June 30 | |
| |
| |
2025 | |
| - | |
2026 | |
| 8,750 | |
2027 | |
| 8,750 | |
Total | |
$ | 17,500 | |
Components
of Loan and Security Agreement
SCHEDULE OF LOAN AND SECURITY AGREEMENT
| |
June 30, 2024 | | |
March 31, 2024 | |
| |
| | |
| |
Amount outstanding | |
$ | 17,500 | | |
$ | 17,500 | |
Debt discount | |
| (5,163 | ) | |
| (4,541 | ) |
Amortization of debt discount | |
| 1,559 | | |
| 1,149 | |
Final payment liability | |
| 1,050 | | |
| 613 | |
Total | |
$ | 14,946 | | |
$ | 14,721 | |
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- DefinitionThe entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.
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v3.24.2.u1
LEASE REVENUES
|
3 Months Ended |
Jun. 30, 2024 |
Lease Revenues |
|
LEASE REVENUES |
NOTE
12 – LEASE REVENUES
The
Company leases the LungFit® PH device to customers and receives a fixed rental fee over the term of the arrangement. Contract terms
(generally one-to-three years) vary by customer and may include options to terminate the contract or options to extend the contract.
The LungFit® PH lease agreements are accounted for as operating leases. The non-lease components, including consumables and device-related
services are combined with the predominant lease component under the practical expedient. The fixed rental fee is recognized over the
period of the lease agreement on a straight-line basis.
The
Company recognized $0.6 million and $0.1 million in LungFit® PH lease revenues for the three months ended June 30, 2024 and June
30,2023, respectively, included revenues in the accompanying consolidated statements of operations. The Company received approximately
$0.4 million and $0 million in cash associated with leases which the Company is the for lessor for the three months ended June 30, 2024
and June 30,2023, respectively. The Company has recorded $0.1 million and $0 million in deferred revenue as of June 30, 2024 and June
30, 2023, respectively.
The
following schedule presents the minimum future lease payments under the LungFit® PH lease arrangements that were in place as of June
30, 2024 (in thousands):
SCHEDULE
OF MATURITY OF FUTURE LEASE PAYMENTS
Future lease payments under the LungFit® PH lease arrangements | |
June 30 | |
| |
| |
2025 | |
$ | 2,155 | |
2026 | |
| 1,975 | |
2027 | |
| 997 | |
2028 | |
| 29 | |
Total | |
$ | 5,156 | |
The
LungFit® PH devices are included in Property and Equipment (Note 3) and have the useful life of five years. Depreciation expense
related to leased LungFit® PH devices was $0.5 million and $0.2 million for the three months ended June 30, 2024 and June 30, 2023,
respectively. The depreciation expense related to customer leased devices is included in the cost of revenue in the consolidated statements
of operations and comprehensive loss.
Capitalized
sales commissions
Sales
commissions related to obtaining LungFit® PH lease agreements are accounted for as initial direct costs and are capitalized and amortized
on a straight-line basis over the lease term. Total capitalized costs for the three months ended June 30, 2024 and 2023 were immaterial.
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v3.24.2.u1
SUBSEQUENT EVENTS
|
3 Months Ended |
Jun. 30, 2024 |
Subsequent Events [Abstract] |
|
SUBSEQUENT EVENTS |
NOTE
13 – SUBSEQUENT EVENTS
On
July 8, 2024 David Webster joined the company as Chief Commercial Officer (CCO). In connection with his appointment, the Company granted
an inducement stock option award (the “Inducement Option”) to Mr. Webster upon his entering into employment with the Company
in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4) (the “Inducement Award”). The Inducement Option is being granted
effective as of July 8, 2024 and is exercisable for the purchase of 125,000 shares of the Company’s common stock, at an exercise
price equal to the last reported sale price on Nasdaq on July 8, 2024. The Inducement Award was approved by the independent compensation
committee of the Board in accordance with Nasdaq Stock Market Listing Rule 5635(c)(4). The Inducement Option has a ten-year term and
will vest over a four-year period, with 25% of the shares underlying the stock option award vesting on the first anniversary of the date
of grant and annually thereafter in three equal installments, subject to Mr. Webster’s continued service with the Company through
the applicable vesting dates. The Inducement Award is subject to the terms and conditions of the Company’s 2013 Equity Incentive
Plan.
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- DefinitionThe entire disclosure for significant events or transactions that occurred after the balance sheet date through the date the financial statements were issued or the date the financial statements were available to be issued. Examples include: the sale of a capital stock issue, purchase of a business, settlement of litigation, catastrophic loss, significant foreign exchange rate changes, loans to insiders or affiliates, and transactions not in the ordinary course of business.
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v3.24.2.u1
SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (Policies)
|
3 Months Ended |
Jun. 30, 2024 |
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 June 30, 2024 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, 2024 (the “2024
Annual Report”), filed with the U.S. Securities and Exchange Commission (the “SEC”) on June 24, 2024. 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 2024 Annual Report on Form 10-K.
|
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 result 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 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. Of the restricted cash originally recorded
in the unaudited condensed consolidated statement of cash flows for the three months ended June 30, 2023, $2.5 million has been reclassified
and is now recorded in prepaid assets. 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 generally accepted accounting principles in the United States (“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 significantly differ from those estimates. On an ongoing basis, the Company evaluates its significant estimates
and assumptions including expense recognition and accrual assumptions under consulting and clinical trial agreements, stock-based compensation,
impairment assessments, accounting for licensed rights to use technologies and other long-lived assets, contingency recognition and accruals
and the determination of valuation allowance requirements on deferred tax attributes.
|
Going Concern, Liquidity and Other Uncertainties |
Going
Concern, Liquidity and Other Uncertainties
The
Company used cash in operating activities of $10.2 million for the three months ended June 30, 2024, and has accumulated losses attributable
to the stockholders of Beyond Air of $251.9 million. The Company had cash, cash equivalents and marketable securities of $21.4 million
as of June 30, 2024.
The
Company expects to incur net losses and have significant cash outflows for at least the next year, 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 the Company to meet its obligations.
Management
currently has various funding options in place to raise additional capital such as a debt line of $12.5 million with Avenue (as defined below) and its affiliates,
subject to the agent and lenders receiving investment committee approval and negotiations of the terms and conditions between both parties, (Note 11),
an ATM sales agreement with $32.9 million of available funds (Note 4), assets that can be leveraged such as Beyond Cancer, Autism, LungFit
PH international partnerships, LungFit PRO international partnerships and LungFit GO partnerships. Additionally, in January 2022 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. The securities purchase agreement entered into in March 2024 contains restrictions to the Company’s
ability to enter into variable rate transactions for a period of 6 months.
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. A combination study with anti-PD1 therapy is expected to begin before the
end of calendar 2024.
The
Company’s future capital needs and the adequacy of its available funds will depend on many factors, including, but not necessarily
limited to the success and costs of commercialization of the Company’s approved product and the actual cost and time necessary
for current and anticipated preclinical studies, clinical trials and other actions needed to obtain certification or regulatory approval
of the Company’s product candidates.
The
Company will be required to raise additional funds through equity or debt securities offerings or strategic collaboration and/or licensing
agreements in order to fund operations if it is unable to generate enough product or royalty revenues, if any. Such financing may not
be available on acceptable terms, or at all, and the Company’s failure to raise capital when needed could have a material adverse
effect on its strategic objectives, results of operations and financial condition.
The accompanying unaudited 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 ITS 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.
|
Lease Revenue Recognition |
Lease
Revenue Recognition
The
Company generates revenue from the leases of its LungFit® PH devices to its customers under fixed fee arrangements over periods of
up to three years. The fixed fee is typically broken down into ratable monthly payments over the term of the arrangement. The Company’s
customers include hospitals and medical facilities. The Company’s LungFit® PH leases include filters, calibration gas, bagging
kits, cables, adapters, and other components and accessories required to use the LungFit® PH device (the “Consumables”).
The Consumables’ quantities are varied and may be supplied upon demand of the customers and are unlimited, or the arrangement may
provide for the maximum quantities available to the customer over the term of the arrangement. The Company’s LungFit® PH leases
also include maintenance and training required to use the LungFit® PH device, as well as device back-up services (the “Services”),
which are recorded in cost of revenue.
The
Company accounts for its rental arrangements of LungFit® PH devices in accordance with Accounting Standards Codification 842, Leases
(“ASC 842”). Under ASC 842, leases may be classified as either financing, sales-type, or operating, and the Company is required
to disclose key information about leasing arrangements. The classification determines the pattern of revenue recognition and classification
within the statement of operations and comprehensive loss. The Company typically classifies the rental arrangement of its LungFit®
PH contracts as operating leases. The Company’s leases do not contain any restrictive covenants or any material residual value
guarantees. The Company’s equipment leases may contain renewal options which range from one month to two years. The lease term
is adjusted for renewal or termination options that the Company believe the customer is reasonably certain to exercise.
The
Company elected the practical expedient applied to operating leases not to separate lease and non-lease components as long as the lease
and at non-lease components have the same timing and pattern of transfer. As such, the non-lease components, including the Consumables
and Services, are combined with the predominant lease component. The total fixed fees that the Company is reasonably certain to collect
are recognized on a straight line basis over the term of the arrangement. Additionally, the Company made an accounting policy election
to present LungFit® PH revenue net of sales and other similar taxes.
Amounts
billed in advance of performance obligations being satisfied are recognized as deferred revenue.
At
the lease commencement date, the Company will defer initial direct costs, including commission expense and the cost is recognized over
the lease term on the same basis as lease income.
The
Company records the costs of shipping related to contract devices and consumables in cost of revenue in its consolidated statements of
operations.
See
Note 12 to the unaudited condensed consolidated financial statements for more information regarding leasing arrangements.
|
Fair Value Measurements |
Fair
Value Measurements
As
of June 30, 2024 and March 31, 2024, the Company’s financial instruments included restricted cash, marketable securities, accounts
payable, long-term debt, liability classified warrants and derivative liabilities. The carrying amounts reported in the accompanying
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 ITS 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 at June 30, 2024 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 | |
| 17,213 | | |
| 17,213 | | |
| - | | |
| - | |
Mutual funds | |
| - | | |
| - | | |
| - | | |
| - | |
Total assets measured and recorded at fair value | |
$ | 17,213 | | |
$ | 17,213 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities : | |
| | | |
| | | |
| | | |
| | |
Warrant liability | |
$ | 56 | | |
$ | - | | |
$ | - | | |
$ | 56 | |
Derivative liability | |
| 256 | | |
| - | | |
| - | | |
| 256 | |
Total liabilities measured and recorded at fair value | |
$ | 312 | | |
$ | 0 | | |
$ | - | | |
$ | 312 | |
The
fair value amounts at March 31, 2024 are:
(in thousands) | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Marketable securities : | |
| | | |
| | | |
| | | |
| | |
Corporate debt securities | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
Government securities | |
| 16,388 | | |
| 16,388 | | |
| - | | |
| - | |
Mutual funds | |
| 6,702 | | |
| 6,702 | | |
| - | | |
| - | |
Total assets measured and recorded at fair value | |
$ | 23,090 | | |
$ | 23,090 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities : | |
| | | |
| | | |
| | | |
| | |
Warrant liability | |
$ | 275 | | |
$ | - | | |
$ | - | | |
$ | 275 | |
Derivative liability | |
| 1,314 | | |
| - | | |
| - | | |
| 1,314 | |
Total liabilities measured and recorded at fair value | |
$ | 1,589 | | |
$ | - | | |
$ | - | | |
$ | 1,589 | |
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)
Level
3 Valuation
The
common stock warrants issued in connection with the Loan and Security Agreement in June 2023 (Note 11) are recorded as a warrant
liability within the unaudited condensed consolidated balance sheet at June 30, 2024 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
At June 30, 2024 | |
Warrants | | |
Derivative | |
Expected term (in years) | |
| 4 | | |
| 3 | |
Volatility | |
| 90 | % | |
| 90 | % |
Risk-free rate | |
| 4.24 | % | |
| 4.52 | % |
At March 31, 2024 | |
Warrants | | |
Derivative | |
Expected term (in years) | |
| 4.25 | | |
| 3.25 | |
Volatility | |
| 88 | % | |
| 86 | % |
Risk-free rate | |
| 4.09 | % | |
| 4.38 | % |
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 three months ended June 30, 2024 (in thousands):
SCHEDULE
OF CHANGES IN FAIR VALUE OF WARRANTS AND DERIVATIVES
| |
Warrants | | |
Derivative | |
Balance at March 31,2024 | |
$ | 275 | | |
$ | 1,314 | |
Issuances | |
| - | | |
| - | |
Change in fair value | |
| (219 | ) | |
| (1,058 | ) |
Balance at June 30, 2024 | |
$ | 56 | | |
$ | 256 | |
|
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 investments 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 June 30, 2024 and March 31, 2024, restricted cash included approximately $0.2 million and $0.2 million, respectively.
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)
|
Concentration of Credit Risk |
Concentration
of Credit Risk
Financial
instruments that potentially subject the Company to concentrations of credit risk consist of cash accounts in a financial institution,
which at times, may exceed the federal depository insurance coverage of $250,000 in the United States, A$250,000 in Australia, $25,000
in Bermuda, €100,000 in Ireland and €100,000 in Cyprus. There is currently no official federal depository insurance in Israel.
The Company has not experienced losses on these accounts, and management believes the Company is not exposed to significant risks on
such accounts. As of June 30, 2024, the Company had greater than $250,000 at United States financial institutions, greater than A$250,000
at Australian financial institutions, greater than €100,000 at Irish financial institutions and also has funds on deposit in Israel.
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, MARKETABLE SECURITIES AND RESTRICTED CASH
(in thousands) | |
June 30, 2024 | | |
March 31, 2024 | |
Cash and cash equivalents | |
$ | 4,161 | | |
$ | 11,378 | |
Restricted cash | |
| 229 | | |
| 230 | |
Total cash, cash equivalents and restricted cash | |
$ | 4,390 | | |
$ | 11,608 | |
Marketable securities: | |
| | | |
| | |
Marketable debt securities | |
| - | | |
| - | |
Corporate debt securities | |
$ | - | | |
$ | - | |
U.S. government securities | |
| 17,213 | | |
| 16,388 | |
Mutual fund (ultra-short-term income) | |
| - | | |
| 6,702 | |
Total marketable securities | |
$ | 17,213 | | |
$ | 23,090 | |
| |
| | | |
| | |
Total cash, cash equivalents, marketable securities and restricted cash | |
$ | 21,603 | | |
$ | 34,698 | |
The
following table summarizes our short-term marketable securities with unrealized gains and losses as of June 30, 2024, 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 | |
| 17,213 | | |
| 90 | |
Mutual fund (ultra-short-term income) | |
| - | | |
| - | |
Total short-term marketable securities | |
$ | 17,213 | | |
$ | 90 | |
The
following table summarizes our short-term marketable securities with unrealized gains and losses as of March 31, 2024, aggregated by
major security type:
(in thousands) | |
Fair Value | | |
Unrealized Gains and (Losses) | |
Corporate debt securities | |
$ | - | | |
$ | - | |
U.S. government securities | |
| 16,388 | | |
| 117 | |
Mutual fund (ultra-short-term income) | |
| 6,702 | | |
| 6 | |
Total short-term marketable securities | |
$ | 23,090 | | |
$ | 123 | |
All
marketable securities are A- or higher rated. No marketable securities have maturities greater than 12 months. All investments are level
1 investments.
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)
|
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 June 30, 2024,
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 at June 30, 2024:
SCHEDULE
OF SEGMENT FINANCIAL INFORMATION BY BUSINESS SEGMENT
(in thousands) | |
Beyond Air | | |
Beyond Cancer | | |
Total | |
Cash, cash equivalents, marketable securities and certain restricted cash | |
$ | 13,371 | | |
$ | 8,230 | | |
$ | 21,603 | |
All other assets | |
| 24,144 | | |
| 755 | | |
| 24,897 | |
Total assets | |
$ | 37,515 | | |
$ | 8,985 | | |
$ | 46,500 | |
Total liabilities | |
$ | (27,722 | ) | |
$ | (1,078 | ) | |
$ | (28,801 | ) |
Net assets | |
$ | 9,793 | | |
$ | 7,907 | | |
$ | 17,699 | |
Non-controlling interests | |
$ | - | | |
$ | 1,570 | | |
$ | 1,570 | |
The
following table summarizes segment financial information by business segment at March 31, 2024:
(in thousands) | |
Beyond Air | | |
Beyond Cancer | | |
Total | |
Cash, cash equivalents, marketable securities and certain restricted cash | |
$ | 23,591 | | |
$ | 10,877 | | |
$ | 34,468 | |
All other assets | |
| 21,747 | | |
| 746 | | |
| 22,493 | |
Total assets | |
$ | 45,338 | | |
$ | 11,623 | | |
$ | 56,961 | |
Total liabilities | |
$ | (28,810 | ) | |
$ | (965 | ) | |
$ | (29,775 | ) |
Net assets | |
$ | 16,528 | | |
$ | 10,658 | | |
$ | 27,186 | |
Non-controlling interests | |
$ | - | | |
$ | 2,138 | | |
$ | 2,138 | |
The
following table summarizes segment financial performance by business segment for the three months ended June 30, 2024:
(in thousands) | |
Beyond Air | | |
Beyond Cancer | | |
Total | |
Revenue | |
$ | 683 | | |
$ | - | | |
$ | 683 | |
Net loss for the three months ended June 30, 2024 | |
$ | (8,786 | ) | |
$ | (4,269 | ) | |
$ | (13,055 | ) |
The
following table summarizes segment financial performance by business segment for the three months ended June 30, 2023:
(in thousands) | |
Beyond Air | | |
Beyond Cancer | | |
Total | |
| |
| | |
| | |
| |
Revenue | |
$ | 59 | | |
$ | - | | |
$ | 59 | |
Net loss for the three months ended June 30, 2023 | |
$ | (10,256 | ) | |
$ | (4,799 | ) | |
$ | (15,055 | ) |
BEYOND
AIR, INC. AND ITS SUBSIDIARIES
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE
2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (continued)
|
Research and Development |
Research
and Development
Research
and development expenses are charged to the unaudited 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 June 30, 2024 and
June 30, 2023, the Company did not
receive any AU Tax Rebates.
|
Supplier Concentration |
Supplier
Concentration
The
Company relies on third-party suppliers to provide materials for its devices and consumables. In the three months ended June 30, 2024,
the Company purchased approximately 87% of its materials from one third party vendor. In the three months ended June 30, 2023, the Company
purchased approximately 84% of its materials from two third-party vendors, with these vendors representing 65% and 19%, respectively.
|
Leases |
Leases
Operating
lease assets are included within operating lease right-of-use assets, and the corresponding operating lease obligation on the consolidated
balance sheets as of June 30, 2024 and March 31, 2024 in accordance with ASC 842, Leases. The Company has elected not to present
short-term leases as these leases have a lease term of 12 months or less at lease inception and do not contain purchase options or renewal
terms that the Company is reasonably certain to exercise. All other lease assets and lease liabilities are recognized based on the present
value of lease payments over the lease term at commencement date. Because most of the Company’s leases do not provide an implicit
rate of return, the Company used an incremental borrowing rate based on the information available at adoption date in determining the
present value of lease payments.
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v3.24.2.u1
SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (Tables)
|
3 Months Ended |
Jun. 30, 2024 |
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 at June 30, 2024 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 | |
| 17,213 | | |
| 17,213 | | |
| - | | |
| - | |
Mutual funds | |
| - | | |
| - | | |
| - | | |
| - | |
Total assets measured and recorded at fair value | |
$ | 17,213 | | |
$ | 17,213 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities : | |
| | | |
| | | |
| | | |
| | |
Warrant liability | |
$ | 56 | | |
$ | - | | |
$ | - | | |
$ | 56 | |
Derivative liability | |
| 256 | | |
| - | | |
| - | | |
| 256 | |
Total liabilities measured and recorded at fair value | |
$ | 312 | | |
$ | 0 | | |
$ | - | | |
$ | 312 | |
The
fair value amounts at March 31, 2024 are:
(in thousands) | |
Total | | |
Level 1 | | |
Level 2 | | |
Level 3 | |
| |
| | |
| | |
| | |
| |
Marketable securities : | |
| | | |
| | | |
| | | |
| | |
Corporate debt securities | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
Government securities | |
| 16,388 | | |
| 16,388 | | |
| - | | |
| - | |
Mutual funds | |
| 6,702 | | |
| 6,702 | | |
| - | | |
| - | |
Total assets measured and recorded at fair value | |
$ | 23,090 | | |
$ | 23,090 | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Liabilities : | |
| | | |
| | | |
| | | |
| | |
Warrant liability | |
$ | 275 | | |
$ | - | | |
$ | - | | |
$ | 275 | |
Derivative liability | |
| 1,314 | | |
| - | | |
| - | | |
| 1,314 | |
Total liabilities measured and recorded at fair value | |
$ | 1,589 | | |
$ | - | | |
$ | - | | |
$ | 1,589 | |
|
SCHEDULE OF VALUING THE WARRANTS AND DERIVATIVES |
SCHEDULE
OF VALUING THE WARRANTS AND DERIVATIVES
At June 30, 2024 | |
Warrants | | |
Derivative | |
Expected term (in years) | |
| 4 | | |
| 3 | |
Volatility | |
| 90 | % | |
| 90 | % |
Risk-free rate | |
| 4.24 | % | |
| 4.52 | % |
At March 31, 2024 | |
Warrants | | |
Derivative | |
Expected term (in years) | |
| 4.25 | | |
| 3.25 | |
Volatility | |
| 88 | % | |
| 86 | % |
Risk-free rate | |
| 4.09 | % | |
| 4.38 | % |
|
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 three months ended June 30, 2024 (in thousands):
SCHEDULE
OF CHANGES IN FAIR VALUE OF WARRANTS AND DERIVATIVES
| |
Warrants | | |
Derivative | |
Balance at March 31,2024 | |
$ | 275 | | |
$ | 1,314 | |
Issuances | |
| - | | |
| - | |
Change in fair value | |
| (219 | ) | |
| (1,058 | ) |
Balance at June 30, 2024 | |
$ | 56 | | |
$ | 256 | |
|
SCHEDULE OF CASH AND CASH EQUIVALENTS, MARKETABLE SECURITIES 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, MARKETABLE SECURITIES AND RESTRICTED CASH
(in thousands) | |
June 30, 2024 | | |
March 31, 2024 | |
Cash and cash equivalents | |
$ | 4,161 | | |
$ | 11,378 | |
Restricted cash | |
| 229 | | |
| 230 | |
Total cash, cash equivalents and restricted cash | |
$ | 4,390 | | |
$ | 11,608 | |
Marketable securities: | |
| | | |
| | |
Marketable debt securities | |
| - | | |
| - | |
Corporate debt securities | |
$ | - | | |
$ | - | |
U.S. government securities | |
| 17,213 | | |
| 16,388 | |
Mutual fund (ultra-short-term income) | |
| - | | |
| 6,702 | |
Total marketable securities | |
$ | 17,213 | | |
$ | 23,090 | |
| |
| | | |
| | |
Total cash, cash equivalents, marketable securities and restricted cash | |
$ | 21,603 | | |
$ | 34,698 | |
|
SUMMARY OF SHORT-TERM MARKETABLE SECURITIES WITH UNREALIZED GAINS AND LOSSES |
The
following table summarizes our short-term marketable securities with unrealized gains and losses as of June 30, 2024, 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 | |
| 17,213 | | |
| 90 | |
Mutual fund (ultra-short-term income) | |
| - | | |
| - | |
Total short-term marketable securities | |
$ | 17,213 | | |
$ | 90 | |
The
following table summarizes our short-term marketable securities with unrealized gains and losses as of March 31, 2024, aggregated by
major security type:
(in thousands) | |
Fair Value | | |
Unrealized Gains and (Losses) | |
Corporate debt securities | |
$ | - | | |
$ | - | |
U.S. government securities | |
| 16,388 | | |
| 117 | |
Mutual fund (ultra-short-term income) | |
| 6,702 | | |
| 6 | |
Total short-term marketable securities | |
$ | 23,090 | | |
$ | 123 | |
|
SCHEDULE OF SEGMENT FINANCIAL INFORMATION BY BUSINESS SEGMENT |
The
following table summarizes segment financial information by business segment at June 30, 2024:
SCHEDULE
OF SEGMENT FINANCIAL INFORMATION BY BUSINESS SEGMENT
(in thousands) | |
Beyond Air | | |
Beyond Cancer | | |
Total | |
Cash, cash equivalents, marketable securities and certain restricted cash | |
$ | 13,371 | | |
$ | 8,230 | | |
$ | 21,603 | |
All other assets | |
| 24,144 | | |
| 755 | | |
| 24,897 | |
Total assets | |
$ | 37,515 | | |
$ | 8,985 | | |
$ | 46,500 | |
Total liabilities | |
$ | (27,722 | ) | |
$ | (1,078 | ) | |
$ | (28,801 | ) |
Net assets | |
$ | 9,793 | | |
$ | 7,907 | | |
$ | 17,699 | |
Non-controlling interests | |
$ | - | | |
$ | 1,570 | | |
$ | 1,570 | |
The
following table summarizes segment financial information by business segment at March 31, 2024:
(in thousands) | |
Beyond Air | | |
Beyond Cancer | | |
Total | |
Cash, cash equivalents, marketable securities and certain restricted cash | |
$ | 23,591 | | |
$ | 10,877 | | |
$ | 34,468 | |
All other assets | |
| 21,747 | | |
| 746 | | |
| 22,493 | |
Total assets | |
$ | 45,338 | | |
$ | 11,623 | | |
$ | 56,961 | |
Total liabilities | |
$ | (28,810 | ) | |
$ | (965 | ) | |
$ | (29,775 | ) |
Net assets | |
$ | 16,528 | | |
$ | 10,658 | | |
$ | 27,186 | |
Non-controlling interests | |
$ | - | | |
$ | 2,138 | | |
$ | 2,138 | |
The
following table summarizes segment financial performance by business segment for the three months ended June 30, 2024:
(in thousands) | |
Beyond Air | | |
Beyond Cancer | | |
Total | |
Revenue | |
$ | 683 | | |
$ | - | | |
$ | 683 | |
Net loss for the three months ended June 30, 2024 | |
$ | (8,786 | ) | |
$ | (4,269 | ) | |
$ | (13,055 | ) |
The
following table summarizes segment financial performance by business segment for the three months ended June 30, 2023:
(in thousands) | |
Beyond Air | | |
Beyond Cancer | | |
Total | |
| |
| | |
| | |
| |
Revenue | |
$ | 59 | | |
$ | - | | |
$ | 59 | |
Net loss for the three months ended June 30, 2023 | |
$ | (10,256 | ) | |
$ | (4,799 | ) | |
$ | (15,055 | ) |
|
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- DefinitionTabular disclosure of financial instrument measured at fair value on recurring or nonrecurring basis. Includes, but is not limited to, instrument classified in shareholders' equity.
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v3.24.2.u1
PROPERTY AND EQUIPMENT (Tables)
|
3 Months Ended |
Jun. 30, 2024 |
Property, Plant and Equipment [Abstract] |
|
SCHEDULE OF PROPERTY AND EQUIPMENT |
Property
and equipment consist of the following:
SCHEDULE OF PROPERTY AND EQUIPMENT
(in thousands) | |
June 30, 2024 | | |
March 31, 2024 | |
| |
| | |
| |
Clinical and medical equipment | |
$ | 2,174 | | |
$ | 2,174 | |
Equipment deployable as part of a service offering | |
| 11,638 | | |
| 8,208 | |
Computer equipment | |
| 855 | | |
| 860 | |
Furniture and fixtures | |
| 534 | | |
| 534 | |
Leasehold improvements | |
| 612 | | |
| 612 | |
Property
and equipment, gross | |
| 15,812 | | |
| 12,388 | |
Accumulated depreciation | |
| (3,695 | ) | |
| (3,024 | ) |
Property
and equipment, net | |
$ | 12,117 | | |
$ | 9,364 | |
|
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v3.24.2.u1
STOCKHOLDERS’ EQUITY (Tables)
|
3 Months Ended |
Jun. 30, 2024 |
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 three months ended June 30, 2024 is as follows:
SCHEDULE OF RESTRICTED STOCK AWARDS
| |
Number Of Shares | | |
Weighted Average Grant Date Fair Value | |
| |
| | |
| |
Unvested as of April 1, 2024 | |
| 618,900 | | |
$ | 6.98 | |
Granted | |
| - | | |
| - | |
Vested | |
| - | | |
| - | |
Forfeited | |
| (6,000 | ) | |
| 14.36 | |
Unvested as of June 30, 2024 | |
| 612,900 | | |
$ | 6.91 | |
|
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
| |
June 30, 2024 | |
|
June 30, 2023 | |
Risk-free interest rate | |
| 4.3-4.5 | % |
|
| 3.5 - 3.9 | % |
Expected volatility (Beyond Air) | |
| 83.5 – 83.8 | % |
|
| 81.6-82.7 | % |
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 months ended June 30, 2024 and June 30, 2023:
SCHEDULE
OF STOCK-BASED COMPENSATION EXPENSE
|
|
2024 |
|
|
2023 |
|
|
|
Three Months Ended |
|
(in thousands) |
|
June 30, |
|
|
|
2024 |
|
|
2023 |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
629 |
|
|
$ |
1,206 |
|
General and administrative |
|
|
2,750 |
|
|
|
4,911 |
|
Total stock-based compensation expense |
|
$ |
3,379 |
|
|
$ |
6,115 |
|
|
SUMMARY OF COMPANY’S OUTSTANDING WARRANTS |
A
summary of the Company’s outstanding warrants as of June 30, 2024 is as follows:
SUMMARY
OF COMPANY’S OUTSTANDING WARRANTS
Warrant Holders | |
Number of Warrants | | |
Exercise Price | | |
Intrinsic Value (in thousands) | | |
Date of Expiration | |
| |
| | |
| | |
| | |
| |
March 2020 loan | |
| 172,187 | | |
$ | 7.26 | | |
$ | - | | |
| March 2025 | |
NitricGen agreement | |
| 80,000 | | |
$ | 6.90 | | |
| - | | |
| January 2028 | |
Avenue agreement | |
| 233,843 | | |
$ | 1.66 | | |
| - | | |
| June 2028 | |
March 2024 Roth/Laidlaw raise | |
| 9,638,556 | | |
$ | 2.25 | | |
| - | | |
| March 2027 | |
Avenue extension agreement | |
| 100,000 | | |
$ | 1.28 | | |
| - | | |
| June 2029 | |
Total | |
| 10,224,586 | | |
$ | 2.35 | | |
$ | - | | |
| | |
|
2013 Beyond Air Equity Incentive Plan [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
SCHEDULE OF OPTION ACTIVITY |
A
summary of the change in options for the three months ended June 30, 2024 is as follows:
SCHEDULE OF 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, 2024 | | |
| 11,283,469 | | |
$ | 4.45 | | |
| 8.0 | | |
$ | 760 | |
Granted | | |
| 27,500 | | |
| 4.25 | | |
| - | | |
| - | |
Exercised | | |
| - | | |
| - | | |
| - | | |
| - | |
Forfeited | | |
| (144,125 | ) | |
| 4.94 | | |
| - | | |
| - | |
Outstanding as of June 30, 2024 | | |
| 11,166,844 | | |
$ | 4.41 | | |
| 7.76 | | |
$ | 0 | |
Exercisable as of June 30, 2024 | | |
| 4,758,469 | | |
$ | 5.44 | | |
| 5.95 | | |
$ | 0 | |
|
2021 Beyond Cancer Ltd Equity Incentive Plan [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
SCHEDULE OF OPTION ACTIVITY |
SCHEDULE
OF 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, 2024 | | |
| 3,819,000 | | |
$ | 5.50 | | |
| 8.3 | | |
$ | - | |
Granted | | |
| - | | |
| - | | |
| - | | |
| - | |
Exercised | | |
| - | | |
| - | | |
| - | | |
| - | |
Forfeited | | |
| (62,250 | ) | |
| 5.50 | | |
| - | | |
| - | |
Outstanding as of June 30, 2024 | | |
| 3,756,750 | | |
$ | 5.50 | | |
| 8.0 | | |
$ | 0 | |
Exercisable as of June 30, 2024 | | |
| 1,354,000 | | |
$ | 5.50 | | |
| 7.8 | | |
$ | 0 | |
|
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v3.24.2.u1
OTHER CURRENT ASSETS AND PREPAID EXPENSES (Tables)
|
3 Months Ended |
Jun. 30, 2024 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] |
|
SCHEDULE OF CURRENT ASSETS AND PREPAID EXPENSES |
A
summary of current assets and prepaid expenses is as follows (in thousands):
SCHEDULE OF CURRENT ASSETS AND PREPAID EXPENSES
| |
June 30, 2024 | | |
March 31, 2024 | |
Prepaid research and development | |
$ | 148 | | |
$ | 104 | |
Prepaid insurance | |
| 605 | | |
| 886 | |
Prepaid rents and tenant improvements | |
| 48 | | |
| 49 | |
Value added tax receivable | |
| 179 | | |
| 229 | |
Deposits to secure manufacturing materials | |
| 5,019 | | |
| 5,019 | |
Demonstration materials | |
| 145 | | |
| 228 | |
Other | |
| 261 | | |
| 277 | |
Total | |
$ | 6,405 | | |
$ | 6,792 | |
Prepaid
expenses and other current assets | |
$ | 6,405 | | |
$ | 6,792 | |
|
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v3.24.2.u1
ACCRUED EXPENSES (Tables)
|
3 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
SUMMARY OF ACCRUED EXPENSES |
A
summary of the accrued expenses as of June 30, 2024 and March 31, 2024 is as follows (in thousands):
SUMMARY OF ACCRUED EXPENSES
| |
June 30, 2024 | | |
March 31, 2024 | |
Research and development | |
$ | 848 | | |
$ | 965 | |
Professional fees | |
| 575 | | |
| 466 | |
Employee salaries and benefits | |
| 1,280 | | |
| 1,302 | |
Contingent litigation and settlements (Note 10) | |
| 200 | | |
| 400 | |
Circassia settlement – current portion (Note 8) | |
| 4,500 | | |
| 4,500 | |
Deferred revenue | |
| - | | |
| 138 | |
Goods received not invoiced | |
| 130 | | |
| 356 | |
Other | |
| 141 | | |
| 275 | |
Total short-term accrued expenses | |
$ | 7,674 | | |
$ | 8,402 | |
|
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v3.24.2.u1
BASIC AND DILUTED NET INCOME (LOSS) PER SHARE OF COMMON STOCK (Tables)
|
3 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
SCHEDULE OF POTENTIAL ANTI-DILUTIVE SECURITIES |
SCHEDULE
OF POTENTIAL ANTI-DILUTIVE SECURITIES
| |
June 30, 2024 | | |
June 30, 2023 | |
| |
| | |
| |
Common stock warrants | |
| 10,224,586 | | |
| 694,363 | |
Common stock options | |
| 11,166,844 | | |
| 8,132,952 | |
Restricted shares | |
| 612,900 | | |
| 1,095,300 | |
Loan and Security – conversion feature (note 11) | |
| 1,390,176 | | |
| 392,465 | |
Total | |
| 23,394,506 | | |
| 10,315,080 | |
Anti-dilutive
securities | |
| 23,394,506 | | |
| 10,315,080 | |
|
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v3.24.2.u1
LOANS (Tables)
|
3 Months Ended |
Jun. 30, 2024 |
Debt Disclosure [Abstract] |
|
SCHEDULE OF MATURITY OF LONG TERM LOAN |
SCHEDULE
OF MATURITY OF LONG TERM LOAN
Maturity of Long-Term Loan (in thousands) | |
June 30 | |
| |
| |
2025 | |
| - | |
2026 | |
| 8,750 | |
2027 | |
| 8,750 | |
Total | |
$ | 17,500 | |
|
SCHEDULE OF LOAN AND SECURITY AGREEMENT |
Components
of Loan and Security Agreement
SCHEDULE OF LOAN AND SECURITY AGREEMENT
| |
June 30, 2024 | | |
March 31, 2024 | |
| |
| | |
| |
Amount outstanding | |
$ | 17,500 | | |
$ | 17,500 | |
Debt discount | |
| (5,163 | ) | |
| (4,541 | ) |
Amortization of debt discount | |
| 1,559 | | |
| 1,149 | |
Final payment liability | |
| 1,050 | | |
| 613 | |
Total | |
$ | 14,946 | | |
$ | 14,721 | |
|
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v3.24.2.u1
LEASE REVENUES (Tables)
|
3 Months Ended |
Jun. 30, 2024 |
LungFit® PH [Member] |
|
SCHEDULE OF MATURITY OF FUTURE LEASE PAYMENTS |
The
following schedule presents the minimum future lease payments under the LungFit® PH lease arrangements that were in place as of June
30, 2024 (in thousands):
SCHEDULE
OF MATURITY OF FUTURE LEASE PAYMENTS
Future lease payments under the LungFit® PH lease arrangements | |
June 30 | |
| |
| |
2025 | |
$ | 2,155 | |
2026 | |
| 1,975 | |
2027 | |
| 997 | |
2028 | |
| 29 | |
Total | |
$ | 5,156 | |
|
X |
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SCHEDULE OF FAIR VALUE ON A RECURRING BASIS (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Mar. 31, 2024 |
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
$ 17,213
|
$ 23,090
|
Liabilities : |
|
|
Total liabilities measured and recorded at fair value |
312
|
1,589
|
Fair Value, Inputs, Level 1 [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
17,213
|
23,090
|
Liabilities : |
|
|
Total liabilities measured and recorded at fair value |
0
|
|
Fair Value, Inputs, Level 2 [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
|
|
Liabilities : |
|
|
Total liabilities measured and recorded at fair value |
|
|
Fair Value, Inputs, Level 3 [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
|
|
Liabilities : |
|
|
Total liabilities measured and recorded at fair value |
312
|
1,589
|
Corporate Debt Securities [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
|
|
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
|
|
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
|
|
Corporate Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
|
|
US Government Agencies Debt Securities [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
17,213
|
16,388
|
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
17,213
|
16,388
|
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
|
|
US Government Agencies Debt Securities [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
|
|
Mutual Fund [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
|
6,702
|
Mutual Fund [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
|
|
Mutual Fund [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
|
|
Mutual Fund [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
|
|
Warrant [Member] |
|
|
Liabilities : |
|
|
Total liabilities measured and recorded at fair value |
56
|
275
|
Warrant [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Liabilities : |
|
|
Total liabilities measured and recorded at fair value |
|
|
Warrant [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Liabilities : |
|
|
Total liabilities measured and recorded at fair value |
|
|
Warrant [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Liabilities : |
|
|
Total liabilities measured and recorded at fair value |
56
|
275
|
Derivative [Member] |
|
|
Liabilities : |
|
|
Total liabilities measured and recorded at fair value |
256
|
1,314
|
Derivative [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Liabilities : |
|
|
Total liabilities measured and recorded at fair value |
|
|
Derivative [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Liabilities : |
|
|
Total liabilities measured and recorded at fair value |
|
|
Derivative [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Liabilities : |
|
|
Total liabilities measured and recorded at fair value |
$ 256
|
1,314
|
Mutual Funds [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
|
6,702
|
Mutual Funds [Member] | Fair Value, Inputs, Level 1 [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
|
6,702
|
Mutual Funds [Member] | Fair Value, Inputs, Level 2 [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
|
|
Mutual Funds [Member] | Fair Value, Inputs, Level 3 [Member] |
|
|
Marketable securities : |
|
|
Total assets measured and recorded at fair value |
|
|
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v3.24.2.u1
SCHEDULE OF CASH AND CASH EQUIVALENTS, MARKETABLE SECURITIES AND RESTRICTED CASH (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Mar. 31, 2024 |
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
Cash and cash equivalents |
$ 4,161
|
$ 11,378
|
Restricted cash |
229
|
230
|
Total cash, cash equivalents and restricted cash |
4,390
|
11,608
|
Marketable securities: |
|
|
Total marketable securities |
17,213
|
23,090
|
Total cash, cash equivalents, marketable securities and restricted cash |
21,603
|
34,698
|
Marketable Debt Securities [Member] |
|
|
Marketable securities: |
|
|
Total marketable securities |
|
|
Corporate Debt Securities [Member] |
|
|
Marketable securities: |
|
|
Total marketable securities |
|
|
US Government Agencies Debt Securities [Member] |
|
|
Marketable securities: |
|
|
Total marketable securities |
17,213
|
16,388
|
Mutual Fund [Member] |
|
|
Marketable securities: |
|
|
Total marketable securities |
|
$ 6,702
|
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SUMMARY OF SHORT-TERM MARKETABLE SECURITIES WITH UNREALIZED GAINS AND LOSSES (Details) - USD ($) $ in Thousands |
3 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Mar. 31, 2024 |
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
Marketable securities |
$ 17,213
|
|
$ 23,090
|
Total short-term marketable securities, Unrealized gains and (losses) |
90
|
$ (75)
|
123
|
Corporate Debt Securities [Member] |
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
Marketable securities |
|
|
|
Total short-term marketable securities, Unrealized gains and (losses) |
|
|
|
US Government Agencies Debt Securities [Member] |
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
Marketable securities |
17,213
|
|
16,388
|
Total short-term marketable securities, Unrealized gains and (losses) |
90
|
|
117
|
Mutual Fund [Member] |
|
|
|
Debt Securities, Held-to-Maturity, Allowance for Credit Loss [Line Items] |
|
|
|
Marketable securities |
|
|
6,702
|
Total short-term marketable securities, Unrealized gains and (losses) |
|
|
$ 6
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SCHEDULE OF SEGMENT FINANCIAL INFORMATION BY BUSINESS SEGMENT (Details) - USD ($) $ in Thousands |
3 Months Ended |
|
Jun. 30, 2024 |
Jun. 30, 2023 |
Mar. 31, 2024 |
Cash, cash equivalents, marketable securities and certain restricted cash |
$ 21,603
|
|
$ 34,698
|
Total assets |
46,500
|
|
56,961
|
Non-controlling interests |
1,570
|
|
2,138
|
Net loss for the three months ended June 30, 2023 |
(12,201)
|
$ (14,095)
|
|
Business Segment [Member] |
|
|
|
Cash, cash equivalents, marketable securities and certain restricted cash |
21,603
|
|
34,468
|
All other assets |
24,897
|
|
22,493
|
Total assets |
46,500
|
|
56,961
|
Total liabilities |
(28,801)
|
|
(29,775)
|
Net assets |
17,699
|
|
27,186
|
Non-controlling interests |
1,570
|
|
2,138
|
Revenue |
683
|
59
|
|
Net loss for the three months ended June 30, 2023 |
(13,055)
|
(15,055)
|
|
Business Segment [Member] | Beyond Air Inc. [Member] |
|
|
|
Cash, cash equivalents, marketable securities and certain restricted cash |
13,371
|
|
23,591
|
All other assets |
24,144
|
|
21,747
|
Total assets |
37,515
|
|
45,338
|
Total liabilities |
(27,722)
|
|
(28,810)
|
Net assets |
9,793
|
|
16,528
|
Non-controlling interests |
|
|
|
Revenue |
683
|
59
|
|
Net loss for the three months ended June 30, 2023 |
(8,786)
|
(10,256)
|
|
Business Segment [Member] | Beyond Cancer Ltd [Member] |
|
|
|
Cash, cash equivalents, marketable securities and certain restricted cash |
8,230
|
|
10,877
|
All other assets |
755
|
|
746
|
Total assets |
8,985
|
|
11,623
|
Total liabilities |
(1,078)
|
|
(965)
|
Net assets |
7,907
|
|
10,658
|
Non-controlling interests |
1,570
|
|
$ 2,138
|
Revenue |
|
|
|
Net loss for the three months ended June 30, 2023 |
$ (4,269)
|
$ (4,799)
|
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v3.24.2.u1
SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES (Details Narrative) shares in Millions |
|
|
1 Months Ended |
3 Months Ended |
|
|
|
Jun. 30, 2024
USD ($)
shares
|
Feb. 04, 2022
USD ($)
|
Jan. 31, 2022
USD ($)
|
Jun. 30, 2024
USD ($)
shares
|
Jun. 30, 2023
USD ($)
|
Jun. 30, 2024
EUR (€)
shares
|
Jun. 30, 2024
AUD ($)
shares
|
Jun. 30, 2024
BMD ($)
shares
|
Mar. 31, 2024
USD ($)
shares
|
Nov. 04, 2021 |
Prepaid assets |
|
|
|
|
$ 2,500,000
|
|
|
|
|
|
Net cash used in operating activities |
|
|
|
$ (10,180,000)
|
$ (17,153,000)
|
|
|
|
|
|
Accumulated deficit |
$ (251,898,000)
|
|
|
(251,898,000)
|
|
|
|
|
$ (239,697,000)
|
|
Cash, cash equivalents and marketable securities |
$ 21,400,000
|
|
|
21,400,000
|
|
|
|
|
|
|
Concentration risk benchmark description |
the Company had greater than $250,000 at United States financial institutions, greater than A$250,000
at Australian financial institutions, greater than €100,000 at Irish financial institutions and also has funds on deposit in Israel.
|
|
|
|
|
|
|
|
|
|
Marketable securities non-current |
$ 0
|
|
|
$ 0
|
|
|
|
|
|
|
Accounts Payable [Member] | Supplier Concentration Risk [Member] | Two Third-party Vendors [Member] |
|
|
|
|
|
|
|
|
|
|
Concentration Risk, Percentage |
|
|
|
87.00%
|
84.00%
|
|
|
|
|
|
Accounts Payable [Member] | Supplier Concentration Risk [Member] | Third-Party Vendor One [Member] |
|
|
|
|
|
|
|
|
|
|
Concentration Risk, Percentage |
|
|
|
|
65.00%
|
|
|
|
|
|
Accounts Payable [Member] | Supplier Concentration Risk [Member] | Third-Party Vendor Two [Member] |
|
|
|
|
|
|
|
|
|
|
Concentration Risk, Percentage |
|
|
|
|
19.00%
|
|
|
|
|
|
Australian Taxation Office [Member] |
|
|
|
|
|
|
|
|
|
|
Tax Rebate |
|
|
|
$ 0
|
$ 0
|
|
|
|
|
|
Beyond Cancer Ltd [Member] |
|
|
|
|
|
|
|
|
|
|
Equity method ownership percentage |
80.00%
|
|
|
80.00%
|
|
80.00%
|
80.00%
|
80.00%
|
|
80.00%
|
UNITED STATES |
|
|
|
|
|
|
|
|
|
|
Cash FDIC insured amount |
$ 250,000
|
|
|
$ 250,000
|
|
|
|
|
|
|
AUSTRALIA |
|
|
|
|
|
|
|
|
|
|
Cash FDIC insured amount |
|
|
|
|
|
|
$ 250,000
|
|
|
|
BERMUDA |
|
|
|
|
|
|
|
|
|
|
Cash FDIC insured amount |
|
|
|
|
|
|
|
$ 25,000
|
|
|
IRELAND |
|
|
|
|
|
|
|
|
|
|
Cash FDIC insured amount | € |
|
|
|
|
|
€ 100,000
|
|
|
|
|
CYPRUS |
|
|
|
|
|
|
|
|
|
|
Cash FDIC insured amount | € |
|
|
|
|
|
€ 100,000
|
|
|
|
|
Contract Manufacturer [Member] |
|
|
|
|
|
|
|
|
|
|
Restricted Cash |
$ 200,000
|
|
|
$ 200,000
|
|
|
|
|
$ 200,000
|
|
Maximum [Member] |
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance or sale of equity |
|
|
$ 200,000,000
|
|
|
|
|
|
|
|
Lessee finance lease renewal term |
2 years
|
|
|
2 years
|
|
2 years
|
2 years
|
2 years
|
|
|
Minimum [Member] |
|
|
|
|
|
|
|
|
|
|
Lessee finance lease renewal term |
1 month
|
|
|
1 month
|
|
1 month
|
1 month
|
1 month
|
|
|
2022 ATM [Member] |
|
|
|
|
|
|
|
|
|
|
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Shares Available for Grant | shares |
32.9
|
|
|
32.9
|
|
32.9
|
32.9
|
32.9
|
32.9
|
|
Proceeds from issuance or sale of equity |
|
$ 50,000,000
|
|
|
|
|
|
|
|
|
Loan and Security Agreement [Member] | Avenue Capital Management II LP [Member] |
|
|
|
|
|
|
|
|
|
|
Line of credit |
$ 12,500,000
|
|
|
$ 12,500,000
|
|
|
|
|
|
|
Beyond Cancer Ltd [Member] |
|
|
|
|
|
|
|
|
|
|
Non-controlling owners interest |
20.00%
|
|
|
20.00%
|
|
20.00%
|
20.00%
|
20.00%
|
|
|
X |
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SCHEDULE OF PROPERTY AND EQUIPMENT (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Mar. 31, 2024 |
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 15,812
|
$ 12,388
|
Accumulated depreciation |
(3,695)
|
(3,024)
|
Property and equipment, net |
12,117
|
9,364
|
Clinical and Medical Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
2,174
|
2,174
|
Equipment Deployable as Part of Service Offering [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
11,638
|
8,208
|
Computer Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
855
|
860
|
Furniture and Fixtures [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
534
|
534
|
Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Property and equipment, gross |
$ 612
|
$ 612
|
X |
- DefinitionAmount of accumulated depreciation, depletion and amortization for physical assets used in the normal conduct of business to produce goods and services.
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SCHEDULE OF RESTRICTED STOCK AWARDS (Details) - Restricted Stock [Member]
|
3 Months Ended |
Jun. 30, 2024
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Unvested Number of Shares, Beginning balance | shares |
618,900
|
Weighted Average Grant Date Fair Value, Beginning balance | $ / shares |
$ 6.98
|
Number of Shares, Granted | shares |
|
Weighted Average Grant Date Fair Value, Granted | $ / shares |
|
Number of Shares, Vested | shares |
|
Weighted Average Grant Date Fair Value, Vested | $ / shares |
|
Number of Shares, Forfeited | shares |
(6,000)
|
Weighted Average Grant Date Fair Value, Forfeited | $ / shares |
$ 14.36
|
Unvested Number of Shares, Ending balance | shares |
612,900
|
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$ 6.91
|
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SCHEDULE OF OPTION ACTIVITY (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Mar. 31, 2024 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
Weighted Average Remaining Contractual Life - Options |
|
8 years 3 months 18 days
|
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 |
11,283,469
|
|
Weighted Average Exercise Price - Options, Outstanding at beginning of period |
$ 4.45
|
|
Weighted Average Remaining Contractual Life - Options |
7 years 9 months 3 days
|
8 years
|
Aggregate Intrinsic Value, Outstanding at beginning of period |
$ 760
|
|
Number of Options Outstanding, Granted |
27,500
|
|
Weighted Average Exercise Price - Options, Granted |
$ 4.25
|
|
Aggregate Intrinsic Value, Granted |
|
|
Number of Options Outstanding, Exercised |
|
|
Weighted Average Exercise Price - Options, Exercised |
|
|
Aggregate Intrinsic Value, Exercised |
|
|
Number of Options Outstanding, Forfeited |
(144,125)
|
|
Weighted Average Exercise Price - Options, Forfeited |
$ 4.94
|
|
Aggregate Intrinsic Value, Forfeited |
|
|
Number of Options, Outstanding at ending of period |
11,166,844
|
11,283,469
|
Weighted Average Exercise Price - Options, Outstanding at ending of period |
$ 4.41
|
$ 4.45
|
Aggregate Intrinsic Value, Outstanding at ending of period |
$ 0
|
$ 760
|
Number of Options Outstanding, Exercisable |
4,758,469
|
|
Weighted Average Exercise Price - Options, Exercisable |
$ 5.44
|
|
Weighted average remaining contractual life - options, exercisable |
5 years 11 months 12 days
|
|
Aggregate Intrinsic Value, Exercisable |
$ 0
|
|
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 |
3,819,000
|
|
Weighted Average Exercise Price - Options, Outstanding at beginning of period |
$ 5.50
|
|
Weighted Average Remaining Contractual Life - Options |
8 years
|
|
Aggregate Intrinsic Value, Outstanding at beginning of period |
|
|
Number of Options Outstanding, Granted |
|
|
Weighted Average Exercise Price - Options, Granted |
|
|
Aggregate Intrinsic Value, Granted |
|
|
Number of Options Outstanding, Exercised |
|
|
Weighted Average Exercise Price - Options, Exercised |
|
|
Aggregate Intrinsic Value, Exercised |
|
|
Number of Options Outstanding, Forfeited |
(62,250)
|
|
Weighted Average Exercise Price - Options, Forfeited |
$ 5.50
|
|
Aggregate Intrinsic Value, Forfeited |
|
|
Number of Options, Outstanding at ending of period |
3,756,750
|
3,819,000
|
Weighted Average Exercise Price - Options, Outstanding at ending of period |
$ 5.50
|
$ 5.50
|
Aggregate Intrinsic Value, Outstanding at ending of period |
$ 0
|
|
Number of Options Outstanding, Exercisable |
1,354,000
|
|
Weighted Average Exercise Price - Options, Exercisable |
$ 5.50
|
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v3.24.2.u1
SUMMARY OF COMPANY’S OUTSTANDING WARRANTS (Details) - USD ($)
|
3 Months Ended |
|
|
Jun. 30, 2024 |
Jun. 21, 2024 |
Jun. 15, 2023 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
Number of Warrants |
10,224,586
|
|
233,843
|
Exercise Price |
$ 2.35
|
$ 1.28
|
$ 5.88
|
Intrinsic Value |
|
|
|
March 2020 Loan [Member] |
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
Number of Warrants |
172,187
|
|
|
Exercise Price |
$ 7.26
|
|
|
Intrinsic Value |
|
|
|
Date of Expiration |
March 2025
|
|
|
NitricGen Agreement [Member] |
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
Number of Warrants |
80,000
|
|
|
Exercise Price |
$ 6.90
|
|
|
Intrinsic Value |
|
|
|
Date of Expiration |
January 2028
|
|
|
Avenue Agreement [Member] |
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
Number of Warrants |
233,843
|
|
|
Exercise Price |
$ 1.66
|
|
|
Intrinsic Value |
|
|
|
Date of Expiration |
June 2028
|
|
|
March 2024 Roth Laidlaw Raise [Member] |
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
Number of Warrants |
9,638,556
|
|
|
Exercise Price |
$ 2.25
|
|
|
Intrinsic Value |
|
|
|
Date of Expiration |
March 2027
|
|
|
Avenue Extension Agreement [Member] |
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
Number of Warrants |
100,000
|
|
|
Exercise Price |
$ 1.28
|
|
|
Intrinsic Value |
|
|
|
Date of Expiration |
June 2029
|
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v3.24.2.u1
STOCKHOLDERS’ EQUITY (Details Narrative) - USD ($) $ / shares in Units, $ in Millions |
|
|
|
3 Months Ended |
12 Months Ended |
|
|
|
|
Mar. 22, 2024 |
Mar. 20, 2024 |
Feb. 04, 2022 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Mar. 31, 2024 |
Jun. 21, 2024 |
Jan. 10, 2024 |
Jun. 15, 2023 |
Nov. 03, 2022 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
|
$ 2.35
|
|
|
$ 1.28
|
|
$ 5.88
|
|
Employee benefits and share based compensation |
|
|
|
$ 0.3
|
$ 0.7
|
|
|
|
|
|
Weighted average remaining contractual term |
|
|
|
|
|
8 years 3 months 18 days
|
|
|
|
|
Number of warrants issued |
|
|
|
|
|
|
100,000
|
|
|
|
2013 Beyond Air Equity Incentive Plan [Member] |
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Number of shares available for grant |
|
|
|
421,558
|
|
|
|
|
|
|
Stock option shares authorized for issuance |
|
|
|
13,600,000
|
|
|
|
3,000,000
|
|
|
Weighted average remaining contractual term |
|
|
|
7 years 9 months 3 days
|
|
8 years
|
|
|
|
|
2013 Beyond Air Equity Incentive Plan [Member] | Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Unrecognized stock-based compensation expense |
|
|
|
$ 1.6
|
|
|
|
|
|
|
Weighted average remaining contractual term |
|
|
|
1 year 7 months 6 days
|
|
|
|
|
|
|
2021 Beyond Cancer Ltd Equity Incentive Plan [Member] |
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Number of shares available for grant |
|
|
|
243,250
|
|
|
|
|
|
|
Stock option shares authorized for issuance |
|
|
|
4,000,000
|
|
|
|
|
|
2,000,000
|
Stock option vesting term, description |
|
|
|
The vesting terms of the options issued under the 2021 BC Plan are generally four years and they expire ten years from the grant date
|
|
|
|
|
|
|
Stock option vesting term |
|
|
|
10 years
|
|
|
|
|
|
|
Weighted average remaining contractual term |
|
|
|
8 years
|
|
|
|
|
|
|
2013 BA Plan [Member] |
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Unrecognized stock-based compensation expense |
|
|
|
$ 9.0
|
|
|
|
|
|
|
Weighted average remaining contractual term |
|
|
|
1 year 9 months 18 days
|
|
|
|
|
|
|
2021 BC Plan [Member] |
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Unrecognized stock-based compensation expense |
|
|
|
$ 7.6
|
|
|
|
|
|
|
Weighted average remaining contractual term |
|
|
|
1 year 4 months 24 days
|
|
|
|
|
|
|
2022 ATM [Member] |
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Net proceeds from equity |
|
|
$ 50.0
|
|
|
|
|
|
|
|
Fees paid percentage |
|
|
3.00%
|
|
|
|
|
|
|
|
Gross proceeds |
|
|
|
$ 0.0
|
$ 5.8
|
|
|
|
|
|
Sale of stock |
|
|
|
|
930,232
|
|
|
|
|
|
Number of shares available for grant |
|
|
|
32,900,000
|
|
32,900,000
|
|
|
|
|
Securities Purchase Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Net proceeds from equity |
$ 14.6
|
|
|
|
|
|
|
|
|
|
Gross proceeds |
|
$ 16.0
|
|
|
|
|
|
|
|
|
Agent commissions |
1.1
|
|
|
|
|
|
|
|
|
|
Other offering costs |
$ 0.3
|
|
|
|
|
|
|
|
|
|
Securities Purchase Agreement [Member] | Related Party [Member] |
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Gross proceeds |
|
1.2
|
|
|
|
|
|
|
|
|
Proceeds from warrants |
|
$ 4.5
|
|
|
|
|
|
|
|
|
Securities Purchase Agreement [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Sale of stock |
|
9,638,556
|
|
|
|
|
|
|
|
|
Securities Purchase Agreement [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Sale of stock |
|
9,638,556
|
|
|
|
|
|
|
|
|
Securities Purchase Agreement [Member] | Common Stock Warrant Shares [Member] |
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Sale of stock |
|
9,638,556
|
|
|
|
|
|
|
|
|
Price per share |
|
$ 1.66
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
$ 2.25
|
|
|
|
|
|
|
|
|
Warrant expiry term |
|
3 years
|
|
|
|
|
|
|
|
|
Placement Agency Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Fees paid percentage |
|
7.00%
|
|
|
|
|
|
|
|
|
Avenue Venture Opportunities Fund L.P [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
|
|
|
|
Number of warrants issued |
|
|
|
|
|
|
100,000
|
|
|
|
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|
3 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive securities |
23,394,506
|
10,315,080
|
Warrant [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive securities |
10,224,586
|
694,363
|
Equity Option [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
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Anti-dilutive securities |
11,166,844
|
8,132,952
|
Restricted Stock [Member] |
|
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Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
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Anti-dilutive securities |
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|
1,095,300
|
Convertible Debt Securities [Member] |
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Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
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COMMITMENTS AND CONTINGENCIES (Details Narrative) - USD ($) $ in Millions |
|
|
1 Months Ended |
3 Months Ended |
|
|
Jan. 31, 2018 |
Jan. 13, 2017 |
Apr. 30, 2023 |
Jun. 30, 2024 |
Sep. 30, 2023 |
Dec. 28, 2021 |
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Loss contingency, damages paid, value |
|
|
$ 7.6
|
|
|
|
Hudson Bay Master Fund [Member] |
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Loss contingency accrual |
|
|
|
|
$ 3.1
|
|
January 2017 Offering [Member] | Hudson Bay Master Fund [Member] |
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Warrants to purchase common stock |
|
|
|
|
|
83,334
|
Cost of Goods and Service Benchmark [Member] | Supplier Concentration Risk [Member] | Supplier [Member] |
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Outstanding amount under purchase |
|
|
|
$ 1.4
|
|
|
Cash deposits |
|
|
|
5.0
|
|
|
Option Agreement [Member] |
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Payments for development and milestone payment |
|
$ 0.5
|
|
|
|
|
Remaining future milestone payments |
|
87.0
|
|
|
|
|
Sales related milestones payments |
|
$ 83.0
|
|
|
|
|
NitricGen Agreement [Member] |
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Remaining future milestone payments |
|
|
|
$ 0.3
|
|
|
NitricGen Agreement [Member] | NitricGen, Inc [Member] |
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Remaining future milestone payments |
$ 2.0
|
|
|
|
|
|
Future payments based on certain milestones |
$ 0.1
|
|
|
|
|
|
Warrants to purchase common stock |
100,000
|
|
|
|
|
|
Warrants to purchase common stock, value |
$ 0.3
|
|
|
|
|
|
NitricGen Agreement [Member] | NitricGen, Inc [Member] | Next Milestones [Member] |
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
Future payments based on certain milestones |
0.1
|
|
|
|
|
|
NitricGen Agreement [Member] | NitricGen, Inc [Member] | After Six Months [Member] |
|
|
|
|
|
|
Loss Contingencies [Line Items] |
|
|
|
|
|
|
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$ 1.5
|
|
|
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v3.24.2.u1
SCHEDULE OF LOAN AND SECURITY AGREEMENT (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Mar. 31, 2024 |
Debt Disclosure [Abstract] |
|
|
Amount outstanding |
$ 17,500
|
$ 17,500
|
Debt discount |
(5,163)
|
(4,541)
|
Amortization of debt discount |
1,559
|
1,149
|
Final payment liability |
1,050
|
613
|
Total |
$ 14,946
|
$ 14,721
|
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v3.24.2.u1
LOANS (Details Narrative) - USD ($)
|
|
|
3 Months Ended |
Jun. 21, 2024 |
Jun. 15, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Debt Instrument [Line Items] |
|
|
|
|
Interest paid |
|
|
$ 600,000
|
$ 0
|
Class of warrant or right, outstanding |
|
233,843
|
10,224,586
|
|
Additional warrants price |
$ 1.28
|
$ 5.88
|
$ 2.35
|
|
Additional warrants issued |
100,000
|
|
|
|
Debt term payment |
$ 87,500
|
|
|
|
Term liability |
|
|
$ 1,100,000
|
|
Principal reimbursed percent |
|
|
3.50%
|
|
Term payment |
|
|
$ 100,000
|
|
Interest, net proceeds |
|
$ 15,800,000
|
|
|
Securities Purchase Agreement [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Debt Instrument, Convertible, Terms of Conversion Feature |
|
|
Upon
|
|
Avenue Capital Group [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Conversion principal amount |
|
|
$ 3,000,000.0
|
|
Conversion stock price |
|
|
130.00%
|
|
Avenue Capital Group [Member] | Common Stock [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Conversion of shares |
|
|
1,390,176
|
|
Conversion amount |
|
|
$ 2.158
|
|
Loan and Security Agreement [Member] |
|
|
|
|
Debt Instrument [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 |
|
$ 5,000,000.0
|
|
|
Loan and Security Agreement [Member] | Tranche 1 [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Secured debt |
|
$ 17,500,000
|
|
|
Loan and Security Agreement [Member] | Tranche 2 [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Principal payment term |
|
additional 6 to 18 months
|
|
|
Revenues |
|
$ 40,000,000.0
|
|
|
Loan and Security Agreement [Member] | Tranche 2 [Member] | Maximum [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Secured debt |
|
$ 10,000,000.0
|
|
|
Product revenue percentage |
|
85.00%
|
|
|
Loan and Security Agreement [Member] | Tranche 3 [Member] | Maximum [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Secured debt |
|
$ 12,500,000
|
|
|
Hudson Bay Master Fund [Member] |
|
|
|
|
Debt Instrument [Line Items] |
|
|
|
|
Accrued liabilities |
|
$ 40,000,000.0
|
|
|
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v3.24.2.u1
SCHEDULE OF MATURITY OF FUTURE LEASE PAYMENTS (Details) - LungFit® PH [Member] $ in Thousands |
Jun. 30, 2024
USD ($)
|
2025 |
$ 2,155
|
2026 |
1,975
|
2027 |
997
|
2028 |
29
|
Total |
$ 5,156
|
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- DefinitionAmount of lessee's undiscounted obligation for lease payment for operating lease.
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v3.24.2.u1
SUBSEQUENT EVENTS (Details Narrative) - Subsequent Event [Member]
|
Jul. 08, 2024
shares
|
Subsequent Event [Line Items] |
|
Exercisable shares |
125,000
|
Vesting description |
The Inducement Option has a ten-year term and
will vest over a four-year period, with 25% of the shares underlying the stock option award vesting on the first anniversary of the date
of grant and annually thereafter in three equal installments, subject to Mr. Webster’s continued service with the Company through
the applicable vesting dates.
|
Vesting percentage |
25.00%
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