UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For
the quarterly period ended
OR
For the transition period from _________to _________
Commission
File Number:
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
| (Address of principal executive offices) | (Zip Code) |
(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: | ||
| The
|
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.
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).
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 ☐ | ||
| 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 shares of common stock, par value $ per share, outstanding.
BEYOND AIR, INC. AND SUBSIDIARIES
INDEX TO FORM 10-Q FILING
FOR THE PERIOD ENDED JUNE 30, 2024
Table of Contents
| 2 |
PART I FINANCIAL INFORMATION
ITEM 1. Financial Statements.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
INDEX
| 3 |
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 | $ | $ | ||||||
| Marketable securities | ||||||||
| Restricted cash | ||||||||
| Accounts receivable | ||||||||
| Inventory | ||||||||
| Other current assets and prepaid expenses | ||||||||
| Total current assets | ||||||||
| Licensed right to use technology | ||||||||
| Right-of-use lease assets | ||||||||
| Property and equipment, net | ||||||||
| Other assets | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses and other current liabilities | ||||||||
| Operating lease liability, current portion | ||||||||
| Loans payable, current portion | ||||||||
| Total current liabilities | ||||||||
| Operating lease liability, net | ||||||||
| Long-term debt, net | ||||||||
| Warrant liability | ||||||||
| Derivative liability | ||||||||
| Total liabilities | ||||||||
| Stockholders’ equity | ||||||||
| Preferred Stock, $ par value per share: shares authorized, shares issued and outstanding | ||||||||
| Common Stock, $ par value per share: shares authorized, shares issued and outstanding as of June 30, 2024 and March 31, 2024, respectively | ||||||||
| Treasury stock | ( | ) | ( | ) | ||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Accumulated other comprehensive income (loss) | ( | ) | ||||||
| Total stockholders’ equity attributable to Beyond Air, Inc. | ||||||||
| Non-controlling interest | ||||||||
| Total equity | ||||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | $ | $ | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 4 |
BEYOND AIR, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(amounts in thousands, except share and per share data)
(UNAUDITED)
| For the Three Months Ended | ||||||||
| June 30, | ||||||||
| 2024 | 2023 | |||||||
| Revenues | $ | $ | ||||||
| Cost of revenues | ( | ) | ( | ) | ||||
| Gross loss | ( | ) | ( | ) | ||||
| Operating expenses: | ||||||||
| Research and development | ( | ) | ( | ) | ||||
| Selling, general and administrative | ( | ) | ( | ) | ||||
| Total operating expenses | ( | ) | ( | ) | ||||
| Loss from operations | ( | ) | ( | ) | ||||
| Other income (expense) | ||||||||
| Dividend and interest income | ||||||||
| Interest and finance expense | ( | ) | ( | ) | ||||
| Change in fair value of warrant liability | ||||||||
| Change in fair value of derivative liability | ||||||||
| Foreign exchange gain / (loss) | ( | ) | ||||||
| Estimated liability for contingent loss | ( | ) | ||||||
| Other income / (expense) | ( | ) | ( | ) | ||||
| Total other income/(expense) | ||||||||
| Net loss before income taxes | ( | ) | ( | ) | ||||
| Provision for income taxes | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Less : net loss attributable to non-controlling interest | ( | ) | ( | ) | ||||
| Net loss attributable to Beyond Air, Inc. | $ | ( | ) | $ | ( | ) | ||
| Foreign currency translation gain | ||||||||
| Comprehensive loss attributable to Beyond Air, Inc. | $ | ( | ) | $ | ( | ) | ||
| Net basic and diluted loss per share attributable to Beyond Air, Inc. | $ | ) | $ | ) | ||||
| Weighted average number of shares, outstanding basic and diluted | ||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 5 |
BEYOND AIR, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(UNAUDITED)
FOR THE THREE MONTHS ENDED JUNE 30, 2024
(amounts in thousands, except share data)
| 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 | $ | $ | ( | ) | $ | $ | ( | ) | $ | ( | ) | $ | $ | |||||||||||||||||||
| Issuance of common stock warrants | ||||||||||||||||||||||||||||||||
| Stock-based compensation | - | |||||||||||||||||||||||||||||||
| Other comprehensive income | - | |||||||||||||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||
| Balance as of June 30, 2024 | $ | $ | ( | ) | $ | $ | ( | ) | $ | $ | $ | |||||||||||||||||||||
FOR THE THREE MONTHS ENDED JUNE 30, 2023
(amounts in thousands, except share data)
| Common Stock | Treasury | Additional Paid-in | Accumulated | Accumulated Other Comprehensive | Non-Controlling | Total | ||||||||||||||||||||||||||
| Number | Amount | Stock | Capital | Deficit | Income | Interest | Equity | |||||||||||||||||||||||||
| Balance as of April 1, 2023 | $ | $ | ( | ) | $ | $ | ( | ) | $ | $ | $ | |||||||||||||||||||||
| Issuance of common stock upon exercise of options | ||||||||||||||||||||||||||||||||
| At the market equity offering stock issuance of common stock, net | ||||||||||||||||||||||||||||||||
| Stock-based compensation | - | |||||||||||||||||||||||||||||||
| Other comprehensive income | - | |||||||||||||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||
| Balance as of June 30, 2023 | $ | $ | ( | ) | $ | $ | ( | ) | $ | $ | $ | |||||||||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 6 |
BEYOND AIR, INC. AND ITS SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(amounts in thousands)
| For the Three Months Ended | ||||||||
| June 30, | ||||||||
| 2024 | 2023 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities | ||||||||
| Depreciation and amortization | ||||||||
| Amortization of licensed right to use technology | ||||||||
| Stock-based compensation | ||||||||
| Amortization of debt discount | ||||||||
| Change in fair value of warrant liability | ( | ) | ( | ) | ||||
| Change in fair value of derivative liability | ( | ) | ( | ) | ||||
| Amortization of operating lease assets | ||||||||
| Un-realized gain in marketable securities | ( | ) | ||||||
| Foreign currency adjustments | ( | ) | ||||||
| Changes in: | ||||||||
| Grant receivable | ( | ) | ||||||
| Inventory | ( | ) | ( | ) | ||||
| Accounts receivable | ( | ) | ( | ) | ||||
| Other current assets and prepaid expenses | ||||||||
| Accounts payable | ( | ) | ||||||
| Accrued expenses | ( | ) | ( | ) | ||||
| Operating lease liabilities | ( | ) | ( | ) | ||||
| Net cash used in operating activities | $ | ( | ) | $ | ( | ) | ||
| Cash flows from investing activities | ||||||||
| Purchase of marketable securities | ( | ) | ( | ) | ||||
| Proceeds from sale of marketable securities | ||||||||
| Purchase of property and equipment | ( | ) | ( | ) | ||||
| Net cash provided by and (used in) investing activities | $ | $ | ( | ) | ||||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of common stock through at the market offerings | ||||||||
| Proceeds from issuance of common stock through exercise of stock options | ||||||||
| Proceeds from loan | ||||||||
| Payment of loan | ( | ) | ( | ) | ||||
| Net cash (used in) and provided by financing activities | $ | ( | ) | $ | ||||
| Effect of exchange rate changes on cash and cash equivalents | ||||||||
| Decrease in cash, cash equivalents and restricted cash | $ | ( | ) | $ | ( | ) | ||
| Cash, cash equivalents and restricted cash at beginning of period | ||||||||
| Cash, cash equivalents and restricted cash at end of period | $ | $ | ||||||
| Supplemental disclosure of non-cash investing and financing activities | ||||||||
| Debt discount | $ | $ | ||||||
| End of term loan liability | $ | ( | ) | $ | ( | ) | ||
| Warrant liability | $ | $ | ( | ) | ||||
| Derivative liability | $ | $ | ( | ) | ||||
| Fixed assets recorded in accounts payable and accrued assets | $ | $ | ||||||
| Supplemental disclosure of cash flow items: | ||||||||
| Interest paid | $ | $ | ||||||
| Income taxes paid | $ | $ | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 7 |
BEYOND AIR, INC. AND ITS SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE 1 ORGANIZATION AND BUSINESS
Beyond Air, Inc. (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
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.
| 8 |
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’
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, $
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 $
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 $
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.
| 9 |
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
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.
| 10 |
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:
| (in thousands) | Total | Level 1 | Level 2 | Level 3 | ||||||||||||
| Marketable securities : | ||||||||||||||||
| Corporate debt securities | $ | $ | $ | $ | ||||||||||||
| Government securities | ||||||||||||||||
| Mutual funds | ||||||||||||||||
| Total assets measured and recorded at fair value | $ | $ | $ | $ | ||||||||||||
| Liabilities : | ||||||||||||||||
| Warrant liability | $ | $ | $ | $ | ||||||||||||
| Derivative liability | ||||||||||||||||
| Total liabilities measured and recorded at fair value | $ | $ | $ | $ | ||||||||||||
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 | ||||||||||||||||
| Mutual funds | ||||||||||||||||
| Total assets measured and recorded at fair value | $ | $ | $ | $ | ||||||||||||
| Liabilities : | ||||||||||||||||
| Warrant liability | $ | $ | $ | $ | ||||||||||||
| Derivative liability | ||||||||||||||||
| Total liabilities measured and recorded at fair value | $ | $ | $ | $ | ||||||||||||
| 11 |
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:
| At June 30, 2024 | Warrants | Derivative | ||||||
| Expected term (in years) | ||||||||
| Volatility | % | % | ||||||
| Risk-free rate | % | % | ||||||
| At March 31, 2024 | Warrants | Derivative | ||||||
| Expected term (in years) | ||||||||
| Volatility | % | % | ||||||
| Risk-free rate | % | % | ||||||
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):
| Warrants | Derivative | |||||||
| Balance at March 31,2024 | $ | $ | ||||||
| Issuances | ||||||||
| Change in fair value | ( | ) | ( | ) | ||||
| Balance at June 30, 2024 | $ | $ | ||||||
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 $
| 12 |
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 $
The following table is the reconciliation of the presentation and disclosure of cash, cash equivalents, marketable securities by major security type and restricted cash as shown on the Company’s condensed consolidated statements of cash flows for:
| (in thousands) | June 30, 2024 | March 31, 2024 | ||||||
| Cash and cash equivalents | $ | $ | ||||||
| Restricted cash | ||||||||
| Total cash, cash equivalents and restricted cash | $ | $ | ||||||
| Marketable securities: | ||||||||
| Marketable debt securities | ||||||||
| Corporate debt securities | $ | $ | ||||||
| U.S. government securities | ||||||||
| Mutual fund (ultra-short-term income) | ||||||||
| Total marketable securities | $ | $ | ||||||
| Total cash, cash equivalents, marketable securities and restricted cash | $ | $ | ||||||
The following table summarizes our short-term marketable securities with unrealized gains and losses as of June 30, 2024, aggregated by major security type:
| (in thousands) | Fair Value | Unrealized (Losses) | ||||||
| Corporate debt securities | $ | $ | ||||||
| U.S. government securities | ||||||||
| Mutual fund (ultra-short-term income) | ||||||||
| Total short-term marketable securities | $ | $ | ||||||
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 (Losses) | ||||||
| Corporate debt securities | $ | $ | ||||||
| U.S. government securities | ||||||||
| Mutual fund (ultra-short-term income) | ||||||||
| Total short-term marketable securities | $ | $ | ||||||
All
marketable securities are A- or higher rated.
| 13 |
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
The following table summarizes segment financial information by business segment at June 30, 2024:
| (in thousands) | Beyond Air | Beyond Cancer | Total | |||||||||
| Cash, cash equivalents, marketable securities and certain restricted cash | $ | $ | $ | |||||||||
| All other assets | ||||||||||||
| Total assets | $ | $ | $ | |||||||||
| Total liabilities | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
| Net assets | $ | $ | $ | |||||||||
| Non-controlling interests | $ | $ | $ | |||||||||
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 | $ | $ | $ | |||||||||
| All other assets | ||||||||||||
| Total assets | $ | $ | $ | |||||||||
| Total liabilities | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
| Net assets | $ | $ | $ | |||||||||
| Non-controlling interests | $ | $ | $ | |||||||||
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 | $ | $ | $ | |||||||||
| Net loss for the three months ended June 30, 2024 | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
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 | $ | $ | $ | |||||||||
| Net loss for the three months ended June 30, 2023 | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||
| 14 |
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
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
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.
| 15 |
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:
| (in thousands) | June 30, 2024 | March 31, 2024 | ||||||
| Clinical and medical equipment | $ | $ | ||||||
| Equipment deployable as part of a service offering | ||||||||
| Computer equipment | ||||||||
| Furniture and fixtures | ||||||||
| Leasehold improvements | ||||||||
| Accumulated depreciation | ( | ) | ( | ) | ||||
| $ | $ | |||||||
Depreciation
and amortization for the three months ended June 30, 2024 and June 30, 2023 was $
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 $
During
the three months ended June 30, 2024, the Company received net proceeds of $
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) shares (the “Shares”) of common
stock and (ii) common stock purchase warrants (the “common stock warrants”) to purchase up to shares
of Common Stock (the “common stock warrant shares”) for gross proceeds of $
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
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 , which was approved by the Company’s stockholders at the 2024 annual stockholder meeting on March 8, 2024. The 2013 BA Plan has shares authorized for issuance. As of June 30, 2024, shares were available under the 2013 BA Plan.
| 16 |
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:
Number Of Shares | Weighted Average Grant Date Fair Value | |||||||
| Unvested as of April 1, 2024 | $ | |||||||
| Granted | ||||||||
| Vested | ||||||||
| Forfeited | ( | ) | ||||||
| Unvested as of June 30, 2024 | $ | |||||||
Stock-based compensation expense related to these grants for the three months ended June 30, 2024 and June 30, 2023 was $ million and $ 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 $ million which is expected to be expensed over the weighted average remaining service period of years.
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 | $ | $ | |||||||||||||||
| Granted | - | ||||||||||||||||
| Exercised | - | ||||||||||||||||
| Forfeited | ( | ) | - | ||||||||||||||
| Outstanding as of June 30, 2024 | $ | $ | |||||||||||||||
| Exercisable as of June 30, 2024 | $ | $ | |||||||||||||||
| 17 |
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. . On November 3, 2022, the Company’s Board of Directors approved an amendment to reserve for issuance an additional shares of common stock. The 2021 BC Plan has shares authorized for issuance. As of June 30, 2024, common shares were available under the 2021 BC Plan.
Number of Options | Weighted Average Exercise Price of Options | Weighted Average Remaining Contractual Life of Options | Aggregate Intrinsic Value (thousands) | ||||||||||||||
| Options outstanding as of April 1, 2024 | $ | $ | |||||||||||||||
| Granted | - | ||||||||||||||||
| Exercised | - | ||||||||||||||||
| Forfeited | ( | ) | - | ||||||||||||||
| Outstanding as of June 30, 2024 | $ | $ | |||||||||||||||
| Exercisable as of June 30, 2024 | $ | $ | |||||||||||||||
As of June 30, 2024, the Company had unrecognized stock-based compensation expense in the 2013 BA Plan of approximately $million which is expected to be expensed over the weighted average remaining service period of years
As of June 30, 2024, the Company had unrecognized stock-based compensation expense in the 2021 BC Plan of approximately $ million which is expected to be expensed over the weighted average remaining service period of years.
June 30, 2024 | June 30, 2023 | |||||||
| Risk-free interest rate | - | % | - | % | ||||
| Expected volatility (Beyond Air) | – | % | - | % | ||||
| Dividend yield | % | % | ||||||
| Expected terms (in years) | ||||||||
| Three Months Ended | ||||||||
| (in thousands) | June 30, | |||||||
| 2024 | 2023 | |||||||
| Research and development | $ | $ | ||||||
| General and administrative | ||||||||
| Total stock-based compensation expense | $ | $ | ||||||
| 18 |
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:
| Warrant Holders | Number of Warrants | Exercise Price | Intrinsic Value (in thousands) | Date of Expiration | ||||||||||||
| March 2020 loan | $ | $ | ||||||||||||||
| NitricGen agreement | $ | |||||||||||||||
| Avenue agreement | $ | |||||||||||||||
| March 2024 Roth/Laidlaw raise | $ | |||||||||||||||
| Avenue extension agreement | $ | |||||||||||||||
| Total | $ | $ | ||||||||||||||
On
June 21, 2024, warrants to purchase up to an aggregate of
NOTE 5 OTHER CURRENT ASSETS AND PREPAID EXPENSES
A summary of current assets and prepaid expenses is as follows (in thousands):
June 30, 2024 | March 31, 2024 | |||||||
| Prepaid research and development | $ | $ | ||||||
| Prepaid insurance | ||||||||
| Prepaid rents and tenant improvements | ||||||||
| Value added tax receivable | ||||||||
| Deposits to secure manufacturing materials | ||||||||
| Demonstration materials | ||||||||
| Other | ||||||||
| Total | $ | $ | ||||||
NOTE 6 ACCRUED EXPENSES
A summary of the accrued expenses as of June 30, 2024 and March 31, 2024 is as follows (in thousands):
June 30, 2024 | March 31, 2024 | |||||||
| Research and development | $ | $ | ||||||
| Professional fees | ||||||||
| Employee salaries and benefits | ||||||||
| Contingent litigation and settlements (Note 10) | ||||||||
| Circassia settlement – current portion (Note 8) | ||||||||
| Deferred revenue | ||||||||
| Goods received not invoiced | ||||||||
| Other | ||||||||
| Total short-term accrued expenses | $ | $ | ||||||
| 19 |
BEYOND AIR, INC. AND ITS SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
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:
June 30, 2024 | June 30, 2023 | |||||||
| Common stock warrants | ||||||||
| Common stock options | ||||||||
| Restricted shares | ||||||||
| Loan and Security – conversion feature (note 11) | ||||||||
| Total | ||||||||
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 $
NOTE 9 GRANT COLLABORATION AGREEMENT
On February 10, 2021, the Company
received a grant for up to $
| 20 |
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 $
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 $
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 $
Contingencies
In
April 2023, the Company paid a total of $
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
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.
| 21 |
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 $
Pursuant
to the Loan Agreement, the Company is subject to a financial covenant requiring the Company to maintain at all times $
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
The
Company also granted the Lenders conversion rights for up to $
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
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 $
| 22 |
BEYOND AIR, INC. AND ITS SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE 11 LOANS (continued)
The
Company received $
| Maturity of Long-Term Loan (in thousands) | June 30 | |||
| 2025 | ||||
| 2026 | ||||
| 2027 | ||||
| Total | $ | |||
Components of Loan and Security Agreement
June 30, 2024 | March 31, 2024 | |||||||
| Amount outstanding | $ | $ | ||||||
| Debt discount | ( | ) | ( | ) | ||||
| Amortization of debt discount | ||||||||
| Final payment liability | ||||||||
| Total | $ | $ | ||||||
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 -to-
The
Company recognized $
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):
| Future lease payments under the LungFit® PH lease arrangements | June 30 | |||
| 2025 | $ | |||
| 2026 | ||||
| 2027 | ||||
| 2028 | ||||
| Total | $ | |||
The
LungFit® PH devices are included in Property and Equipment (Note 3) and have the useful life of
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 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 Award is subject to the terms and conditions of the Company’s 2013 Equity Incentive Plan.
| 23 |
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.
| 24 |
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.
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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.
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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.
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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.
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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.
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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 |
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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 | ||||||
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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.
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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.
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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.
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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.
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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.
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ITEM 6. Exhibits.
* Filed herewith.
** Furnished herewith.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| BEYOND AIR, INC. | |
| /s/ Steven Lisi | |
| Date: August 6, 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) |
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