Form 10-Q Beyond Air, Inc. For: Sep 30
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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: | ||
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 ☐
As of November 7, 2022, there were shares of common stock, par value $0.0001 per share, outstanding.
BEYOND AIR, INC. AND SUBSIDIARIES
INDEX TO FORM 10-Q FILING
FOR THE PERIOD ENDED SEPTEMBER 30, 2022
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)
| September 30, 2022 | March 31, 2022 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Marketable Securities | ||||||||
| Restricted cash | ||||||||
| Inventory, net | ||||||||
| Grant receivable | ||||||||
| 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 | ||||||||
| Operating lease liability | ||||||||
| Loan payable, current portion | ||||||||
| Total current liabilities | ||||||||
| Long-term liabilities | ||||||||
| Operating lease liability | ||||||||
| Long-term debt, net | ||||||||
| Other long-term liabilities | ||||||||
| Total liabilities | ||||||||
| Stockholders’ equity | ||||||||
| Preferred Stock, $ par value per share: shares authorized, shares issued and outstanding | ||||||||
| Common Stock, $ par value per share: shares authorized, and shares issued and outstanding as of September 30, 2022 and March 31, 2022, respectively | ||||||||
| Treasury stock | ( | ) | ( | ) | ||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Accumulated other comprehensive income | ||||||||
| Total stockholders’ equity attributable to Beyond Air, Inc | ||||||||
| Non-controlling interests | ||||||||
| 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 | For the Six Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue | $ | $ | $ | $ | ||||||||||||
| Cost of Revenue | ||||||||||||||||
| Gross Profit / (Loss) | ( | ) | ( | ) | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Operating expenses | ||||||||||||||||
| Operating loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income (loss) | ||||||||||||||||
| Interest expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Foreign exchange gain / (loss) | ( | ) | ( | ) | ||||||||||||
| Other income / (expense) | ( | ) | ( | ) | ||||||||||||
| Total other expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Benefit from income taxes | ||||||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Less : net loss attributable to non-controlling interests | ( | ) | ( | ) | ||||||||||||
| 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 AND SIX MONTHS ENDED SEPTEMBER 30, 2022
(amounts in thousands, except share data)
| Common Stock | Treasury | Additional Paid-in | Accumulated | Accumulated Other Comprehensive | Non-Controlling | Total | ||||||||||||||||||||||||||
| Number | Amount | Stock | Capital | Deficit | Income | Interest | Equity | |||||||||||||||||||||||||
| Balance as of April 1, 2022 | $ | $ | ( | ) | $ | $ | ( | ) | $ | $ | $ | |||||||||||||||||||||
| Issuance of common stock upon exercise of options – cashless | ||||||||||||||||||||||||||||||||
| Stock-based compensation | - | |||||||||||||||||||||||||||||||
| Other comprehensive income | - | |||||||||||||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||
| Balance as of June 30, 2022 | $ | $ | ( | ) | $ | $ | ( | ) | $ | $ | $ | |||||||||||||||||||||
| Common Stock | Treasury | Additional Paid-in | Accumulated | Accumulated Other Comprehensive | Non-Controlling | Total | ||||||||||||||||||||||||||
| Number | Amount | Stock | Capital | Deficit | Income | Interest | Equity | |||||||||||||||||||||||||
| Balance as of July 1, 2022 | $ | $ | ( | ) | $ | $ | ( | ) | $ | $ | $ | |||||||||||||||||||||
| At the Market issuance of common stock, net | ||||||||||||||||||||||||||||||||
| Issuance of common stock upon exercise of options – cashless | ||||||||||||||||||||||||||||||||
| Stock-based compensation | - | |||||||||||||||||||||||||||||||
| Other comprehensive income | - | |||||||||||||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||
| Balance as of September 30, 2022 | $ | $ | ( | ) | $ | $ | ( | ) | $ | $ | $ | |||||||||||||||||||||
| 6 |
BEYOND AIR, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(UNAUDITED)
FOR THE THREE AND SIX MONTHS ENDED SEPTEMBER 30, 2021
(amounts in thousands, except share data)
| Additional | Total | |||||||||||||||||||||||
| Common Stock | Treasury | Paid-in | Accumulated | Shareholders’ | ||||||||||||||||||||
| Number | Amount | Stock | Capital | Deficit | Equity | |||||||||||||||||||
| Balance as of April 1, 2021 | $ | $ | ( | ) | $ | $ | ( | ) | $ | |||||||||||||||
| At the market stock issuance of common stock, net | ||||||||||||||||||||||||
| Issuance of common stock pursuant to a Purchase Agreement, net | ||||||||||||||||||||||||
| Stock-based compensation | ||||||||||||||||||||||||
| Net loss | ( | ) | ( | ) | ||||||||||||||||||||
| Balance as of June 30, 2021 | $ | $ | ( | ) | $ | $ | ( | ) | $ | |||||||||||||||
| Additional | Total | |||||||||||||||||||||||
| Common Stock | Treasury | Paid-in | Accumulated | Shareholders’ | ||||||||||||||||||||
| Number | Amount | Stock | Capital | Deficit | Equity | |||||||||||||||||||
| Balance as of July 1, 2021 | $ | $ | ( | ) | $ | $ | ( | ) | $ | |||||||||||||||
| At the market stock issuance of common stock, net | ||||||||||||||||||||||||
| Issuance of common stock upon exercise of warrants | ( | ) | ||||||||||||||||||||||
| Issuance of common stock upon exercise of stock options | ||||||||||||||||||||||||
| Stock-based compensation | ||||||||||||||||||||||||
| Net loss | ( | ) | ( | ) | ||||||||||||||||||||
| Balance as of September 30, 2021 | $ | $ | ( | ) | $ | $ | ( | ) | $ | |||||||||||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 7 |
BEYOND AIR, INC. AND ITS SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
(amounts in thousands)
| For the Six Months Ended | ||||||||
| September 30, | ||||||||
| 2022 | 2021 | |||||||
| 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 and accretion of debt issuance costs | ||||||||
| Amortization of operating lease assets | ||||||||
| Unrealized loss on marketable securities | ( | ) | ||||||
| Foreign currency adjustments | ||||||||
| Write-off of assets no longer used | ||||||||
| Provision for inventory losses | ||||||||
| Changes in: | ||||||||
| Grant receivable | ||||||||
| Inventory | ( | ) | ||||||
| Other current assets and prepaid expenses | ( | ) | ||||||
| Accounts payable | ||||||||
| Accrued expenses | ( | ) | ||||||
| Net cash used in operating activities | ( | ) | $ | ( | ) | |||
| Cash flows from investing activities | ||||||||
| Purchase of marketable securities | ( | ) | ||||||
| Security deposits made on operating leases | ( | ) | ||||||
| Purchase of property and equipment | ( | ) | ( | ) | ||||
| Net cash used in investing activities | ( | ) | $ | ( | ) | |||
| Cash flows from financing activities | ||||||||
| Proceeds from issuance of common stock in connection with a Purchase agreement | ||||||||
| Proceeds from issuance of common stock through at the Market offerings | ||||||||
| Proceeds from issuance of common stock through exercise of stock options | ||||||||
| Payment of loan | ( | ) | ( | ) | ||||
| Net cash (used in) / provided by financing activities | ( | ) | $ | |||||
| Effect of exchange rate changes on cash and cash equivalents | ||||||||
| Increase (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 | ||||||||
| Right-of-use assets | $ | $ | ||||||
| Operating lease liability | $ | $ | ||||||
| Supplemental disclosure of cash flow items: | ||||||||
| Interest paid | $ | $ | ||||||
| Income taxes paid | $ | $ | ||||||
The accompanying notes are an integral part of these condensed consolidated financial statements.
| 8 |
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 from the U.S. Food and Drug Administration (the “FDA”), for the treatment of term and near-term neonates with hypoxic respiratory failure, commonly referred to as persistent pulmonary hypertension of the newborn (“PPHN”), 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. 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.
The Company believes that LungFit® can be used to treat patients on ventilators that require NO, as well as patients with chronic or acute severe lung infections via delivery through a breathing mask or similar apparatus. Furthermore, the Company believes that there is a high unmet medical need for patients suffering from certain severe lung infections that the LungFit® platform can potentially address. The Company’s current areas of focus with LungFit® are PPHN, viral community-acquired pneumonia (“VCAP”) including COVID-19, bronchiolitis, nontuberculous mycobacteria (“NTM”) lung infection and those with various severe lung infections with underlying chronic obstructive pulmonary disease (“COPD”). 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. The Company’s system will be marketed as a medical device in the U.S.
On
November 4, 2021, Beyond Air reorganized its oncology business into a new private company called Beyond Cancer, Ltd (“Beyond Cancer”).
Beyond Air’s preclinical oncology team and the exclusive right to the intellectual property portfolio utilizing ultra-high concentration
of gaseous nitric oxide (“UNO”) for the treatment of solid tumors now reside with Beyond Cancer. The new subsidiary secured
$
| 9 |
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 consolidated balance sheet as of March 31, 2022 (the “2022 Annual Report”) was filed with the U.S. Securities and Exchange Commission (the “SEC”) on June 28, 2022. The unaudited condensed consolidated financial statements and related disclosures should be read in conjunction with the Company’s financial statements and the related notes thereto included in the 2022 Annual Report on Form 10-K.
Principles of Consolidation
These
consolidated financial statements include the accounts of the Company and the accounts of all 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. These reclassifications had no effect on the reported results of operations.
Use of Estimates
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the reporting period. Actual results could differ from those estimates. On an ongoing basis, the Company evaluates its significant estimates including accruals for expenses under consulting, licensing agreements, and clinical trials, stock-based compensation, contingency recognition and the determination of deferred tax attributes and the valuation allowance thereon.
Liquidity Risks and Uncertainties
The
Company used cash in operating activities of $
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’s access to capital and liquidity currently includes a $
The
Company entered into an At-The-Market Offering Sales Agreement, dated February 4, 2022 (the “2022 ATM”) for $
The Company may be required to raise additional funds through equity or debt securities offerings or strategic collaboration and/or licensing agreements in order to fund operations 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.
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.
| 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 development of the Company’s product candidates or commercialization of its approved product could be further disrupted and adversely affected by a resurgence of the COVID-19 pandemic. The Company experienced significant delays in the supply chain for LungFit® due to the redundancy in parts and suppliers with ventilator manufacturing which has since been remedied. Residual effects from the COVID-19 pandemic on the global supply chain having an effect on our ability to manufacture have been addressed, but the stability of the situation is unclear. The Company continuously assesses the impact COVID-19 may have on the Company’s business plans and its ability to conduct the preclinical studies and clinical trials as well as on the Company’s reliance on third-party manufacturing and global supply chains. However, there can be no assurance that the Company will be able to avoid part or all of any impact from COVID-19 or its consequences if a resurgence occurs.
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, cash equivalents and marketable securities in highly rated financial institutions in Israel, Ireland and the U.S., the balances of which, at times, may exceed federally insured limits.
Marketable securities include investment in fixed income bonds and U.S. Treasury securities that are considered to be highly liquid and easily tradeable. The marketable securities are considered trading securities and are measured at fair value and are accounted for in accordance with ASC 320. The marketable securities are valued using inputs observable in active markets for identical securities and are therefore classified as Level 1 within the Company’s fair value hierarchy.
As
of September 30, 2022 and March 31, 2022, restricted cash included $
The following table is the reconciliation of the presentation and disclosure of cash, cash equivalents, marketable securities by major security type and restricted cash (in thousands):
September 30, 2022 | March 31, 2022 | |||||||
| Cash and cash equivalents | $ | $ | ||||||
| Marketable securities : | ||||||||
| Marketable debt securities | ||||||||
| Corporate debt securities | ||||||||
| US government securities | ||||||||
| Mutual funds | ||||||||
| Total marketable securities | $ | $ | ||||||
| Restricted cash | ||||||||
| Total cash, cash equivalents, short-term investments and restricted cash | $ | $ | ||||||
The following table summarizes our short-term marketable securities with unrealized losses as of September 30, 2022, aggregated by major security type :
| (in thousands) | Fair Value | Unrealized Losses | ||||||
| Corporate debt securities | ( | ) | ||||||
| US government securities | ( | ) | ||||||
| Mutual Funds | ||||||||
| Total short-term marketable securities | $ | $ | ( | ) | ||||
All marketable securities are A- or higher rated.
Only $
| 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)
Revenue Recognition
The Company recognizes revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. To determine revenue recognition for contracts with customers, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligation(s) in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligation(s) in the contract and (v) recognize revenue when (or as) the Company satisfies the performance obligation(s). At contract inception, the Company assesses the goods or services promised within each contract, assesses whether each promised good or service is distinct and identifies those promised goods or services that are performance obligations.
The Company uses judgment to determine (a) the number of performance obligations based on the determination under step (ii) above and whether those performance obligations are distinct from other performance obligations in the contract (b) the transaction price under step (iii) above and (c) the stand-alone selling price for each performance obligation identified in the contract for the allocation of the transaction price in step (iv) above. The Company also uses judgment to determine whether milestones or other variable consideration, except for royalties, should be included in the transaction price. The transaction price is allocated to each performance obligation on an estimated stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under contract are satisfied. Where a portion of non-refundable up-front fees or other payments received are allocated to continuing performance obligations under the terms of a license arrangement, such fees or other payments are recorded as contract liabilities and recognized as revenue when (or as) the underlying performance obligation is satisfied.
Grant Receivable
Under a collaboration arrangement with the Cystic Fibrosis Foundation (“CFF”), grant milestones are achieved subject to certain performance steps and requirements under a development program. Grant milestones are recorded as reimbursements against the applicable portion of the Company’s research and development expenses. Such reimbursements are reflected as a reduction of research and development expenses in the Company’s consolidated statements of operations and comprehensive income (loss), as the performance of research and development services for reimbursement is not considered to be an ongoing component or central to the Company’s operations. See Note 10.
Segment Reporting
Commencing
with the creation of Beyond Cancer in November 2021 (see Note 12), 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 September 30, 2022, Beyond Air, Inc. owns
The following table summarizes segment financial information by business segment for the three and six months ended September 30, 2022:
| (in thousands) | Beyond Air | Beyond Cancer | ||||||
| Cash, cash equivalents, marketable securities and certain restricted cash | $ | $ | ||||||
| All other assets | ||||||||
| Total liabilities | ( | ) | ( | ) | ||||
| Net assets – net liabilities | $ | $ | ||||||
| Non-controlling interests | $ | $ | ||||||
| Net loss for the six months ended September 30, 2022 | $ | ( | ) | $ | ( | ) | ||
| Operating activities included in net loss: | ||||||||
| Depreciation and amortization | ||||||||
| Stock-based compensation expense | ||||||||
| Cash used in operations | $ | ( | ) | $ | ( | ) | ||
| (in thousands) | Beyond Air | Beyond Cancer | ||||||
| Net loss for the three months ended September 30, 2022 | $ | ( | ) | $ | ( | ) | ||
| Operating activities included in net loss: | ||||||||
| Depreciation and amortization | ||||||||
| Stock-based compensation expense | ||||||||
| Cash used in operations | $ | ( | ) | $ | ( | ) | ||
Research and Development
Research
and development expenses are charged to the statement of operations as incurred. Research and development expenses include salaries,
benefits, stock-based compensation and costs incurred by outside laboratories, 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 six months ended September 30, 2022 and September 30, 2021, the Company received an AU Tax Rebate
in the amount of $
| 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)
The Company measures the cost of employee and non-employee services received in exchange for an award of equity instruments based on the grant date fair value of the award. Fair value for restricted stock unit awards is valued using the closing price of the Company’s common stock on the date of grant. The grant date fair value is recognized over the requisite service period during which an employee and non-employee is required to provide service in exchange for the award, using the accelerated method. The grant date fair value of employee and non-employee share options is estimated using the Black-Scholes option pricing model. The risk-free interest rate assumptions were based upon the observed interest rates appropriate for the expected term of the equity instruments. The expected dividend yield was assumed to be zero as the Company has not paid any dividends since its inception and does not anticipate paying dividends in the foreseeable future. Due to the Company’s limited trading history, the Company utilizes weighting of its historical volatility and the implied volatility based on an aggregate of guideline companies. The Company uses the simplified method to estimate the expected term.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation and accumulated amortization. Depreciation and amortization are calculated using the straight-line method over the estimated useful life of the assets as follows:
| Computer equipment | |
| Furniture and fixtures | |
| Clinical and medical equipment | |
| Equipment deployable as part of a service offering | |
| Leasehold improvements |
Licensed Right to Use Technology
Licensed right to use technology that is considered platform technology with alternative future uses is recorded as an intangible asset and is amortized on a straight-line method over its estimated useful life, determined to be thirteen years (see Note 11).
Supplier Concentration
The Company relies on dozens of third-party suppliers to provide materials
for its devices and consumables. In the six months ended September 30, 2022, the Company purchased
approximately
Long-Lived Assets
The Company assess the impairment of long-lived assets on an ongoing basis and whenever events or changes in circumstances indicate that the carrying value may not be recoverable. Factors that the Company considers as potential triggers of an impairment review include the following:
| ● | significant underperformance relative to expected historical or projected future operating results, |
| ● | significant changes in the manner of the Company’s use of the acquired assets or the strategy for its overall business, |
| ● | significant negative regulatory or economic trends, and |
| ● | significant technological changes, which would render the platform technology, equipment, and manufacturing processes obsolete. |
| 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)
Recoverability of assets that will continue to be used in the Company’s operations is measured by comparing the carrying value to the future net undiscounted cash flows expected to be generated by the asset or asset group. Future undiscounted cash flows include estimates of future revenues, driven by market growth rates, and estimates of future costs. There were no events during the reporting periods that were deemed to be a triggering event that would require an impairment assessment.
Income Taxes
The Company accounts for income taxes using the asset and liability method. Accordingly, deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in the tax rate is recognized in income or expense in the period that the change is effective. Tax benefits are recognized when it is probable that the deduction will be sustained. A valuation allowance is established when it is more likely than not that all or a portion of a deferred tax asset will either expire before the Company is able to realize the benefit, or that future deductibility is uncertain. As of September 30, 2022 and March 31, 2022, the Company recorded a valuation allowance to the full extent of the Company’s net deferred tax assets since the likelihood of realization of the benefit does not meet the more-likely-than-not threshold.
The Company’s reserves related to taxes are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is more likely than not to be realized following resolution of any potential contingencies present related to the tax benefit. As of September 30, 2022, the Company had no unrecognized tax benefits or related interest and penalties accrued. The Company has not, as yet, conducted a study of research and development (“R&D”) credit carryforwards. This study may result in an adjustment to the Company’s R&D credit carryforwards; however, until a study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position. The Company’s uncertain tax positions are related to years that remain subject to examination by relevant tax authorities. Since the Company is in a loss carryforward position, the Company is generally subject to examination by the U.S. federal, state and local income tax authorities for all tax years in which a loss carryforward is available.
| 14 |
BEYOND AIR, INC. AND ITS SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE 3 FAIR VALUE MEASUREMENT
The Company’s financial instruments primarily include cash, cash equivalents, restricted cash, accounts payable, and a short-term loan. Due to the short-term nature of these financial instruments, the carrying amounts of these assets and liabilities approximate their fair value. The long-term debt approximates fair value due to the prevailing market conditions for similar debt with remaining maturity and terms.
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value. A fair value hierarchy has been established for valuation inputs that give the highest priority to quoted prices in active markets for identical assets or liabilities and the lowest priority to unobservable inputs. The fair value hierarchy is as follows:
| Level 1 - | quoted prices in active markets for identical assets or liabilities; | |
| Level 2 - | inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; or | |
| Level 3 - | unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
The fair value amounts at September 30, 2022 are :
| (in thousands) | Level 1 | Level 2 | Level 3 | |||||||||
| Marketable securities : | ||||||||||||
| Corporate debt securities | $ | $ | $ | |||||||||
| Government securities | ||||||||||||
| Mutual funds | ||||||||||||
| Marketable Securities | $ | $ | $ | |||||||||
NOTE 4 PROPERTY AND EQUIPMENT
Property and equipment consist of the following as of September 30, 2022 and March 31, 2022:
| (in thousands) | September 30, 2022 | March 31, 2022 | ||||||
| Clinical and medical equipment | $ | $ | ||||||
| Equipment deployable as part of a service offering | ||||||||
| Computer equipment | ||||||||
| Furniture and fixtures | ||||||||
| Leasehold improvements | ||||||||
| Accumulated depreciation and amortization | ( | ) | ( | ) | ||||
| $ | $ | |||||||
Depreciation
and amortization expense for the three months ended September 30, 2022 and September 30, 2021 was $
NOTE 5 STOCKHOLDERS’ EQUITY
On
May 14, 2020, the Company entered into the New Stock Purchase Agreement with LPC (the “New Stock Purchase Agreement”), which
provides for the issuance of up to $
On
February 4, 2022, the Company entered into the “2022 ATM”, allowing the Company to sell its common stock for aggregate sales
proceeds of up to $
For
both the three months and six months ended September 30, 2022, the Company received net proceeds of $
For the three and six months ended September 30, 2021, the Company received net proceeds of $
As of September 30, 2022, there were $
| 15 |
BEYOND AIR, INC. AND ITS SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE 5 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 period ended September 30, 2022 is as follows:
Number Of Shares | Weighted Average Grant Date Fair Value | |||||||
| Unvested as of April 1, 2022 | ||||||||
| Granted | ||||||||
| Vested | ||||||||
| Forfeited | ||||||||
| Unvested as of September 30, 2022 | $ | |||||||
Stock-based compensation expense related to these stock issuances for the three months ended September 30, 2022 and September 30, 2021 was $ thousand and $ thousand, respectively. Stock-based compensation for the six months ended September 30, 2022 and September 30, 2021 was $ thousand and $ thousand, respectively.
Stock Option Plans
The Company’s Fourth 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. . The 2013 BA Plan has shares authorized for issuance. As of September 30, 2022, shares were available under the 2013 BA Plan.
Number Of Options | Weighted Average Exercise Price Options | Weighted Average Remaining Contractual Life- Options | Aggregate Intrinsic Value (in thousands) | |||||||||||||
| Options outstanding as of April 1, 2022 | $ | $ | ||||||||||||||
| Granted | - | - | ||||||||||||||
| Exercised | ( | ) | - | - | ||||||||||||
| Forfeited | ( | ) | - | - | ||||||||||||
| Outstanding as of September 30, 2022 | $ | $ | ||||||||||||||
| Exercisable as of September 30, 2022 | $ | $ | ||||||||||||||
The Company’s 2021 Beyond Cancer Ltd Equity Incentive Plan (the “2021 BC Plan”) allows for awards to officers, directors, employees, and consultants of stock options, restricted stock units and restricted shares of Beyond Cancer’s common stock. . On December 1, 2021, the Company’s Board of Directors approved to reserve for issuance shares of common stock. As of September 30, 2022, shares were available under the 2021 BC Plan.
Number Of Options | Weighted Average Exercise Price–- Options | Weighted Average Remaining Contractual Life- Options | Aggregate Intrinsic Value (thousands) | |||||||||||||
| Options outstanding as of April 1, 2022 | $ | $ | ||||||||||||||
| Granted | - | |||||||||||||||
| Exercise | - | - | ||||||||||||||
| Forfeited | ( | ) | - | |||||||||||||
| Outstanding as of September 30, 2022 | $ | $ | ||||||||||||||
| Exercisable as of September 30, 2022 | $ | $ | ||||||||||||||
| 16 |
BEYOND AIR, INC. AND ITS SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE 5 STOCKHOLDERS’ EQUITY (continued)
As of September 30, 2022, 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. For the six months ended September 30, 2022 and September 30, 2021, the weighted average fair value of options granted was $ and $ per share, respectively.
As of September 30, 2022, 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. For the six months ended September 30, 2022, the weighted average fair value of options granted was $ per share.
September 30, 2022 |
September 30, 2021 |
|||||||
| Risk-free interest rate | - | % | % | |||||
| Expected volatility (Beyond Air) | - | % | – | % | ||||
| Expected volatility (Beyond Cancer) | – | % | n/a | |||||
| Dividend yield | % | % | ||||||
| Expected terms (in years) | ||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| (in thousands) | 2022 | 2021 | 2022 | 2021 | ||||||||||||
| Research and development | $ | $ | $ | $ | ||||||||||||
| General and administrative | ||||||||||||||||
| Total stock-based compensation expense | $ | $ | $ | $ | ||||||||||||
Warrants
A summary of the Company’s outstanding warrants as of September 30, 2022 is as follows:
| Warrant Holders | Number Of Warrants | Exercise Price | Intrinsic Value (in thousands) | Date of Expiration | ||||||||||
| Third-party license agreement | $ | $ | ||||||||||||
| March 2020 loan | $ | |||||||||||||
| NitricGen Agreement | $ | |||||||||||||
| Total | $ | $ | ||||||||||||
| 17 |
BEYOND AIR, INC. AND ITS SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE 5 STOCKHOLDERS’ EQUITY (continued)
No warrants were issued or exercised in the six months ended September 30, 2022. For both the three and six months ended September 30, 2021, warrants were exercised on a cashless basis in exchange for shares.
NOTE 6 OTHER CURRENT ASSETS AND PREPAID EXPENSES
A summary of current assets and prepaid expenses as of September 30, 2022 and March 31, 2022 is as follows (in thousands):
September 30, 2022 | March 31, 2022 | |||||||
| Research and development | $ | $ | ||||||
| Insurance | ||||||||
| Down payment on tooling | ||||||||
| Prepaid rents and tenant improvement | ||||||||
| Prepaid marketing materials | ||||||||
| Value added tax receivable | ||||||||
| Other | ||||||||
| Total | $ | $ | ||||||
NOTE 7 ACCRUED EXPENSES
A summary of the accrued expenses as of September 30, 2022 and March 31, 2022 is as follows (in thousands):
September 30, 2022 | March 31, 2022 | |||||||
| Research and development | $ | $ | ||||||
| Professional fees | ||||||||
| Employee salaries and benefits | ||||||||
| Accrual for contingent liabilities (Note 11) | ||||||||
| Accrued Circassia Settlement (Note 9) | ||||||||
| Accrued NitricGen agreement (Note 11) | ||||||||
| Other | ||||||||
| Total short-term accrued expenses | $ | $ | ||||||
| Accrued Circassia Settlement payments – long term (Note 9) | $ | $ | ||||||
| Total other long-term liabilities | $ | $ | ||||||
| 18 |
BEYOND AIR, INC. AND ITS SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
September 30, 2022 | September 30, 2021 | |||||||
| Common stock warrants | ||||||||
| Common stock options | ||||||||
| Restricted shares | ||||||||
| Total | ||||||||
NOTE 9 LICENSE AGREEMENT
On January 23, 2019, the Company entered into an agreement for commercial rights (the “Circassia Agreement”) with Circassia Limited and its affiliates (collectively, “Circassia”) for PPHN and future related indications at concentrations of < 80 ppm in the hospital setting in the United States and China. On December 18, 2019, the Company terminated the Circassia Agreement.
On
May 25, 2021, the Company and Circassia entered into a Settlement Agreement 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
$
| 19 |
BEYOND AIR, INC. AND ITS SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE 10 GRANT COLLABORATON AGREEMENT
On
February 10, 2021, the Company received a grant for up to $
NOTE 11 COMMITMENTS AND CONTINGENCIES
License Agreements
On
October 22, 2013, the Company entered into a patent license agreement (the “CareFusion Agreement”) with SensorMedics Corporation,
a subsidiary of CareFusion Corp. (“CareFusion”), pursuant to which the Company agreed to pay to CareFusion a non-refundable
upfront fee of $
In
August 2015, BA Ltd. entered into an Option Agreement (the “Option Agreement”) with Pulmonox whereby BA Ltd. acquired the
option (the “Option”) to purchase certain intellectual property assets and rights. On January 13, 2017, the Company exercised
the Option and paid $
| 20 |
BEYOND AIR, INC. AND ITS SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE 11 COMMITMENTS AND CONTINGENCIES (continued)
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 $
See Note 9 for license settlement commitments.
Employment Agreements
Certain agreements between the Company and its officers contain a change of control provision for payment of severance arrangements.
Supply Agreement and Purchase Order
In
August 2020, the Company entered into a supply agreement expiring on December 31, 2024. The agreement will renew automatically for successive
three-year periods unless and until the Company provides twelve months’ notice of its intent not to renew the agreement. The Company
has opened several non-cancellable purchase orders and the outstanding amount remaining under the purchase order as of September 30,
2022 was approximately $
Contingencies
On March 16, 2018, Empery Asset Master, Ltd., Empery Tax Efficient, LP and Empery Tax Efficient II, LP, (collectively, “Empery”) filed a complaint in the Supreme Court of the State of New York (the “Trial Court”) against the Company relating to the notice of adjustment of both the exercise price of and the number of warrant shares issuable under warrants issued to Empery in January 2017. Empery alleges that, as a result of certain circumstances in connection with a February 2018 financing transaction, the warrants issued to Empery in January 2017 provide for adjustments to both the exercise price of the warrants and the number of warrant shares issuable upon such exercise.
On
August 20, 2020, the Trial Court denied the Company’s summary judgment motion as to the first and third claims for relief, but
dismissed the second claim for declaratory judgment as moot (the “August 20 Decision”). The Appellate Division First Department
denied the Company’s appeal of the August 20 Decision on September 30, 2021. Following a three-day bench trial, the Trial Court
issued a decision on October 14, 2021, finding in favor of Empery on the two remaining claims, granting reformation of the Warrant Agreement,
and awarding Empery damages in the aggregate amount of approximately $
On
December 28, 2021 Hudson Bay Master Fund (“Hudson”) filed a lawsuit against us related 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
Hudson’s
complaint alleges breach of contract and that Hudson is entitled to damages estimated at approximately $
| 21 |
BEYOND AIR, INC. AND ITS SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
NOTE 12 BEYOND CANCER AND RELATED PARTY TRANSACTIONS
On
November 4, 2021, the Company announced that Beyond Air and Beyond Cancer, Ltd agreed to terms to which the Company, through its
subsidiaries would be licensing certain intellectual property and other assets related to, or necessary for the development,
commercialization, manufacture and distribution of certain cancer treatment products and/or technologies to a subsidiary of the
Company (the “Transaction”). In connection and concurrently with the closing of the Transaction, Beyond Cancer issued
and sold common shares, par value $to
certain investors pursuant to a subscription agreement (the “Offering”). The Offering consisted of an aggregate of million
common shares of Beyond Cancer at a purchase price of $per
share. The maximum amount of shares offered had been purchased for a total of $
Members
of the Board of Directors of Beyond Air who are also member of the Board of Directors of Beyond Cancer, and their families, are considered
related parties to the Offering. Related parties invested $
The
carrying amount of net assets of the VIE included in the consolidated financial statements, after the elimination of intercompany balances
and transactions, was $
| 22 |
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains “forward-looking statements.” 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 achieve a CE mark for 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 FDA regulation of our approved product and product candidates; | |
| ● | our ability to obtain and retain key executives and attract and retain qualified personnel; | |
| ● | our ability to successfully manage our growth, including as a commercial-stage company; and | |
| ● | our ability to address business disruption and related risks resulting from the COVID-19 pandemic and the responses to curb the spear of COVID-19, which could have a material adverse effect on our business plan. |
Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for 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 Quarter Report on Form 10-Q are the property of Beyond Air, Inc. This Form 10-Q also includes trademarks, tradenames and service marks that are the property of other organizations. Solely for convenience, trademarks and tradenames referred to in this Form 10-Q appear without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights, or that the applicable owner will not assert its rights, to these trademarks and tradenames.
Introduction
We are a commercial-stage medical device and biopharmaceutical company developing a platform of nitric oxide (“NO”) generators and delivery systems (the “LungFit® platform”) capable of generating NO from ambient air. Our first device, LungFit® PH, received premarket approval from the U.S. Food and Drug Administration (the “FDA”), for persistent pulmonary hypertension of the newborn (“PPHN”), in June 2022. The NO generated by the LungFit® PH Systemsystem 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. 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. 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 (previously acute viral pneumonia), bronchiolitis, nontuberculous mycobacteria (“NTM”) lung infection and those with various severe lung infections with underlying chronic obstructive pulmonary disease (“COPD”). 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 EU for the product to be CE marked, as well as comparable foreign regulatory authorities. The Company’s system will be marketed as a medical device in the U.S.
An additional program of Beyond Air targets solid tumors, through our majority-owned affiliate Beyond Cancer, Ltd. (“Beyond Cancer”). The LungFit® platform is not utilized for the solid tumor indication due to need for ultra-high concentrations of gaseous nitric oxide (“UNO”). A proprietary delivery system has been developed that can safely deliver UNO in excess of 10,000 ppm directly to a solid tumor. This program has advanced to phase 1 as enrollment is underway in the first human study.
| 23 |
LungFit® PH is the first FDA approved system using our patented ionizer technology to generate on-demand nitric oxide 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 and clinical studies, we believe that 150 ppm is the minimum therapeutic dose to achieve the desired pulmonary antimicrobial effect of NO. To date, neither the FDA nor comparable foreign regulatory agencies in other countries or regions have approved any NO formulation and/or delivery system for >80 ppm NO.
LungFit® PH for the treatment of Persistent Pulmonary Hypertension of the Newborn (PPHN)
In June 2022, the FDA approved LungFit® PH to treat PPHN. 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 also expect to receive the CE Mark under the Medical Device Regulation (“MDR”) in the EU around the end of calendar year 2022. According to the most recent year-end report from Mallinckrodt Pharmaceuticals, sales of NO were $448.5 million in 2021 (down from $574.1 million in 2020) for the United States, Canada, Japan, Mexico and Australia, with ~90% in the United States. Outside of the U.S. there are multiple market participants which translates to considerably lower sales than in the U.S. We believe the U.S. sales potential of LungFit® PH in PPHN to be greater than $400 million and worldwide sales potential to be greater than $700 million. We initiated the first phase of our commercial launch in June 2022 in the U.S. and will continue to work toward a potential launch in the EU and globally in 2022 and beyond.
LungFit® PRO for the treatment of viral lung infections in hospitalized patients
Viral Community-Acquired Pneumonia (including COVID-19)
Viral pneumonia in adults is most commonly caused by rhinovirus, respiratory syncytial virus (“RSV”) and influenza virus. However, newly emerging viruses (including SARS-CoV-1, SARS-CoV-2, avian influenza A, and H1N1 viruses) have been identified as pathogens contributing to the overall burden of adult viral pneumonia. COVID-19 is an infectious disease caused by SARS-CoV-2, that has resulted in a global pandemic, causing over 6.6 million hospitalizations and over 5 million deaths worldwide as of November 2021. Excluding the pandemic, there are approximately 350,000 annual viral pneumonia hospitalizations in the US, 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 study in late 2020 using our novel LungFit® PRO system at 150 ppm to treat patients with VCAP. The trial is a multi-center, open-label, randomized clinical trial in Israel, including patients infected with COVID-19. Patients are randomized in a 1:1 ratio to receive either inhalations of 150 ppm NO given intermittently for 40 minutes four times per day for up to seven days in addition to standard supportive treatment (“NO+SST”) or standard supportive treatment alone (“SST”). Endpoints related to safety (primary endpoint), oxygen saturation and intensive care unit admission, among others, were assessed.
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We reported interim data from this trial at the American Thoracic Society or ATS International Conference 2021, which was held virtually from May 14, 2021 through May 19, 2021. At the time of the data cut off, the intent-to-treat (“ITT”) analysis population included 19 COVID-19 patients (9 NO + SST vs 10 SST). The data readout showed that 150 ppm NO treatment administered via LungFit® PRO was safe and well tolerated and demonstrated encouraging efficacy signals. From a safety perspective, there were no treatment-related, or possibly related, adverse events or severe adverse events. NO2 levels were below 4 ppm at all timepoints (trial safety threshold is 5 ppm) and methemoglobin (“MetHb”) levels were below 4% at all times (trial safety threshold is 10%). With respect to the requirement of oxygen support beyond hospital stay, 22.2% of subjects in the NO + SST group compared with 40% of control subjects had this requirement. There was an observable trend of shortening the duration of hospital stay and duration on oxygen support for treated patients. The pilot study in adult viral pneumonia, including COVID-19, remained active with trial sites open for enrollment after these data were presented.
We presented additional detailed study results 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 subject hospitalized for VCAP (SARS-CoV-2, n=39; other viruses n=1). The ITT population included 35 subjects with 16 subjects in the inhaled NO group and 19 subjects in the control group. The primary COVID-19 treatments used during the study were Remdesivir (>30%) and Dexamethasone (>65%). Safety data from the study showed 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 reported in the group receiving inhaled NO along with SST, which were determined to be related to underlying conditions and unrelated to study drug/device. From an efficacy perspective, results showed a trend of shortening length of stay (“LOS”) in favor of the inhaled NO treatment group 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 subjects. Subjects 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.
After completion of the study and the 180-follow-up period, incremental data were provided in a poster presentation at IDWeek 2022 held from October 19th through October 23rd in Washington DC. The efficacy results show a trend of shortening LOS in favor of the inhaled NO treatment group. Also, duration of oxygen support, measured in-hospital and at home, was significantly shorter for inhaled NO treated subjects. Additionally, data show a larger decline in c-reactive protein (CRP) from baseline for subjects treated with NO + SST compared to the control group. Analysis of the LungFit PRO study in VCAP patients demonstrates 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. We anticipate commencing a pivotal study in calendar year 2023 following discussions with the FDA.
Bronchiolitis
Bronchiolitis is the leading cause of hospital admission in children less than 1 year of age. The incidence is estimated to be 150 million new cases a year worldwide, with 2-3% (over 3 million) of them severe enough to require hospitalization. Worldwide, 95%3 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.
Our BRO program is currently on hold due to the COVID-19 pandemic. The pivotal study 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 study. Study endpoints for the long-term safety study included the percentage of subjects re-hospitalized for bronchiolitis related reasons, such as wheezing episodes, pneumonia and asthma and the percentage of subjects re-hospitalized for any reason. Data from the study 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 subject re-hospitalization rate for any reason was similar between inhaled NO and control groups. As such, the study 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 study 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% - 25% of all NTM and other forms of NTM that are refractory to antibiotic therapy, frequently require lengthy and repeated hospital stays to manage their condition. There are no treatments specifically indicated for the treatment of M. abscessus lung disease in North America, Europe or Japan.
There are approximately 50,000 to 90,000 people with NTM infections in the U.S. In Asia, the number of patients suffering from NTM surpasses what is seen in the U.S. There is one inhaled antibiotic approved for the treatment of refractory Mycobacterium avium complex (“MAC”). Current guideline-based approaches to treat NTM lung disease involve multi-drug regimens of antibiotics that may cause severe, long lasting side effects, and treatment can be as long as 18 months or more. Median survival for NTM MAC patients is approximately 13 years while median survival for patients with other variations of NTM is typically 4.6 years. The prevalence of human disease attributable to NTM has increased over the past two decades. In a study conducted between 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. In total, a 2015 publication by co-authors from several U.S. government departments stated that annual cases in 2014 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 study and advance the clinical development of inhaled NO to treat NTM pulmonary disease. The trial is enrolling both cystic fibrosis (“CF”) and non-CF patients infected with MAC, M. abscessus or any strain of NTM. The study consists of a run-in period followed by two treatment phases. The run-in period provides a baseline for the efficacy endpoints. The first treatment phase takes place over a two-week period and begins in the hospital setting where patients will be titrated from 150 ppm NO up to 250 ppm NO over several days. During this phase patients receive NO for 40 minutes, four times per day while MetHb levels are monitored. Patients are also trained to use LungFit® GO and subsequently discharged to complete the remaining portion of the two-week treatment period at their home at the highest tolerated NO concentration. For the second treatment phase, a 10-week maintenance phase, the administration is twice daily. The study is evaluating safety, quality of life, physical function, and bacterial load among other parameters.
We reported positive interim results in October 2021. At the time of data cutoff on September 6, 2021, eight subjects were successfully titrated up to 250 ppm NO in the hospital setting, and none required dose reductions during the subsequent at-home portion of the study. The mean age of subjects was 56.6 years (range: 22 – 73 years) with the majority female (87.5%), a distribution consistent with real-world NTM disease, and occurring at a higher rate in older adult women than men. 250 ppm NO was well-tolerated in all subjects with no study discontinuations or treatment-related serious adverse events observed. Methemoglobin and NO2 concentrations remained within acceptable ranges in all subjects during NO treatment, below the safety thresholds of 10% and 5 ppm, respectively.
We reported additional positive interim results at the American Thoracic Society International Conference 2022 (ATS 2022), which was held in San Francisco from May 13, 2022 through May 18, 2022. At the time of data cutoff on April 4, 2022, a total of 15 subjects were enrolled in the pilot study. The mean age of subjects was 62.1 years (range: 22 – 82 years) with the majority female (80%), a distribution consistent with real-world NTM disease. All 15 subjects 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 study. Patients were followed up for 12 weeks after the 12-week treatment period was completed. After completion of the study, we presented detailed data at the CHEST (The American College of Chest Physicians) annual meeting, which was held from October 16, 2022 through October 19, 2022 further supporting development of intermittent high dose NO for the treatment of NTM. The study demonstrated that high does nitric oxide treatment was safe and well-tolerated in both the home and hospital settings. During the 10-week at-home treatment period of the study, a total of 2,492 inhalations were self-administered with overall high treatment compliance (>90%). There were no serious adverse events (SAE) 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 subject achieved culture conversion with three consecutive negative sputum samples. We anticipate commencing a pivotal study late in calendar year 2024 following discussions with the FDA.
Our program in COPD is in the preclinical stage and, subject to obtaining additional financing, is expected to enter clinical trials in calendar year 2023.
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 newly formed, 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 in Beyond Cancer. The funding is expected to be used to accelerate ongoing preclinical work including the completion of IND-enabling studies, completion of a Phase 1 study, 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 will be led by a seasoned leadership team with experience in emerging healthcare companies and clinical oncology.
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UNO has shown anticancer properties in preclinical trials by eliciting an immune response from the host. We have released this preclinical data at several medical/scientific conferences showing the promise of delivering NO at concentrations of 20,000 ppm – 200,000 ppm directly to tumors. Results showed that local tumor ablation with NO conveyed anti-tumor immunity to the host. We recently presented new in vivo and in vitro preclinical data at the American Association for Cancer Research (“AACR”) Annual Meeting 2022. The in vivo study assessed the mode of action following a single 5-minute gaseous NO (“gNO”) treatment 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 timepoint, a marked reduction in the number of myeloid derived suppressor cells was seen 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 of gNO 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.
COVID-19
The development of our product candidates and the commercialization of our approved product could be further disrupted and adversely affected by a resurgence of the COVID-19 pandemic. We experienced significant delays in the supply chain for the LungFit® system due to the redundancy in parts and suppliers for ventilator manufacturing which has since been remedied. We continuously assess the impact that COVID-19 may have on our business plans and our ability to conduct the preclinical studies and clinical trials as well as on our reliance on third-party manufacturing and our supply chain. However, there can be no assurance that we will be able to avoid part or all of any impact from COVID-19 or its consequences if a resurgence occurs.
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 consolidated financial statements are presented in accordance with U.S. GAAP, and all applicable U.S. GAAP accounting standards effective as of September 30, 2022 have been taken into consideration in preparing the unaudited 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, | |
| ● | Licensed right to use Technology, | |
| ● | Stock-based compensation valuation and attribution, and | |
| ● | Income taxes |
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Results of Operations and Comprehensive Loss
Below are the results of operations for the three and six months ended September 30, 2022 and September 30, 2021:
(in thousands)
| For the Three Months Ended | For the Six Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Revenue | $ | - | $ | - | $ | - | $ | - | ||||||||
| Cost of Revenue | 179 | - | 179 | - | ||||||||||||
| Gross Profit / (Loss) | (179 | ) | - | (179 | ) | - | ||||||||||
| Research and development | 4,452 | 2,807 | 7,678 | 5,548 | ||||||||||||
| General and administrative | 7,990 | 3,395 | 16,203 | 7,245 | ||||||||||||
| Operating expenses | 12,442 | 6,201 | 23,882 | 12,793 | ||||||||||||
| Operating loss | (12,621 | ) | (6,201 | ) | (24,061 | ) | (12,793 | ) | ||||||||
| Other income (loss) | ||||||||||||||||
| Interest expense | (48 | ) | (161 | ) | (96 | ) | (323 | ) | ||||||||
| Foreign exchange gain / (loss) | (217 | ) | (0 | ) | (394 | ) | 9 | |||||||||
| Other income / (expense) | 88 | (2,329 | ) | 99 | (2,328 | ) | ||||||||||
| Total other expense | (177 | ) | (2,490 | ) | (391 | ) | (2,642 | ) | ||||||||
| Benefit from income taxes | - | - | - | - | ||||||||||||
| Net loss | $ | (12,797 | ) | $ | (8,692 | ) | $ | (24,452 | ) | $ | (15,435 | ) | ||||
| Less : net loss attributable to non-controlling interests | (830 | ) | - | (1,550 | ) | - | ||||||||||
| Net loss attributable to Beyond Air, Inc. | (11,968 | ) | (8,692 | ) | (22,902 | ) | (15,435 | ) | ||||||||
| Foreign currency translation gain | 171 | - | 343 | - | ||||||||||||
| Comprehensive loss attributable to Beyond Air, Inc. | $ | (11,797 | ) | $ | (8,692 | ) | $ | (22,559 | ) | $ | (15,435 | ) | ||||
| Net basic and diluted loss per share attributable to Beyond Air, Inc. | $ | (0.40 | ) | $ | (0.36 | ) | $ | (0.77 | ) | $ | (0.67 | ) | ||||
| Weighted average number of shares, outstanding, basic and diluted | 29,898,825 | 24,165,965 | 29,893,414 | 23,061,667 | ||||||||||||
Comparison of Three and Six Months Ended September 30, 2022 with the Three and Six Months Ended September 30, 2021
Revenue
On June 28, 2022 the FDA approved LungFit® PH to treat PPHN. No revenue was recognized for the three months or six months ended September 30, 2022 or for the three or six months ended September 30, 2021.
Cost of Revenue
Cost of Revenue of $0.2 million was recognized for the three and six months ended September 30, 2022 compared to $0 for the six and three months ended September 30, 2021. These costs are primarily related to the establishment of several warehouse locations to optimize deliveries to future customers across the U.S.
Research and Development Expenses
Research and development expenses for the three months ended September 30, 2022 were $4.5 million as compared to $2.8 million for the three months ended September 30, 2021. The increase of $1.7 million was primarily attributed to an increase in spending on UNO for $0.9 million, a $0.6 million increase in stock-based compensation and the timing of NTM expenses of $0.1 million.
Research and development expenses for the six months ended September 30, 2022 were $7.7 million as compared to $5.5 million for the six months ended September 30, 2021. The increase of $2.2 million was primarily attributed to the $1.2 million increase of R&D infrastructure and pre-clinical work in UNO, a $1.2 million increase in stock-based compensation, partially offset by a ($0.1) million decrease in NTM project spend and the recognition of a ($0.2) million R&D credit received.
General and Administrative Expenses
General and administrative expenses for the three months ended September 30, 2022 and September 30, 2021 were $8.0 million and $3.4 million, respectively. The increase of $4.6 million was attributed primarily to an increase of $2.5 million due to the creation of the Beyond Cancer entity ($0.4 million of salary expense, $1.9 million of stock-based compensation and $0.2 million of recruiting, office expenses and travel) plus an increase of $2.1 million in Beyond Air ($0.2 million increase in salaries and benefits for commercial and support staff, $1.0 million increase in stock-based compensation, $0.1 million increase in insurance, $0.4 million in consulting fees, $0.3 million increase in travel spend and $0.3 million increase in IT and physical infrastructure was partially offset by a reduction in legal fees of ($0.2) million).
General and administrative expenses for the six months ended September 30, 2022 and September 30, 2021 were $16.2 million and $7.2 million, respectively. The increase of $9.0 million was attributed primarily to an increase of $5.3 million due to the creation of the Beyond Cancer entity ($0.9 million of salary expense, $3.7 million of stock-based compensation, $0.2 million travel and $0.3 million of office expenses and other) plus an increase of $3.7 million in Beyond Air ($0.9 million increase in salaries and benefits for commercial and support staff, $2.0 million increase in stock-based compensation, $0.2 million increase in insurance, $0.3 million in marketing/branding, $0.3 million increase in travel spend, $0.3 million increase in IT and physical infrastructure and $0.2 million in consulting was partially offset by a reduction in legal fees of ($0.6) million).
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Other Income (Loss)
Other Income (Loss) for the three months ended September 30, 2022 and September 30, 2021 was a loss of ($0.2) million and a loss of ($2.5) million, respectively. The reduction of other loss is mainly due to the recording of a contingent liability related to a lawsuit in 2021 for $2.4 million, partially offset by increased foreign exchange losses of $0.2 million.
Other Income (Loss) for the six months ended September 30, 2022 and September 30, 2021 was a loss of ($0.4) million and a loss of ($2.6) million, respectively. The reduction of other loss is mainly due to the recording of a contingent liability related to a lawsuit in 2021 for $2.4 million, partially offset by increased foreign exchange losses of $0.4 million.
Net Loss Attributable to Non-controlling Interests
Net loss attributed to non-controlling interests for the three months ended September 30, 2022, was $0.8 million, compared to $0 for the three months ended September 30, 2021. Net loss attributed to non-controlling interests for the six months ended September 30, 2022, was $1.6 million, compared to $0 for the six months ended September 30, 2021. Non-controlling interests represent 20% of the net loss of our Beyond Cancer subsidiary, which was established in November 2021.
Net Loss Attributed to Common Stockholders
Net loss attributed to common stockholders of Beyond Air, Inc for the three months ended September 30, 2022, was ($12.0) million or a loss of ($0.40) per share, basic and diluted. Our net loss attributed to common stockholders of Beyond Air, Inc for the three months ended September 30, 2021 was ($8.7) million or a loss of ($0.36) per share, basic and diluted.
Net loss attributed to common stockholders of Beyond Air, Inc for the six months ended September 30, 2022, was ($22.9) million or a loss of ($0.77) per share, basic and diluted. Our net loss attributed to common stockholders of Beyond Air, Inc for the six months ended September 30, 2021 was ($15.4) million or a loss of ($0.67) per share, basic and diluted.
Liquidity and Capital Resources
Cash Flows
Below is a summary of the Company’s cash flows activities for the six months ended September 30, 2022 and September 30, 2021:
| Six Months Ended | ||||||||
| September 30, | ||||||||
| (in thousands) | 2022 | 2021 | ||||||
| Net cash provided by (used in): | ||||||||
| Operating activities | $ | (16,059 | ) | $ | (8,898 | ) | ||
| Investing activities | (33,835 | ) | (692 | ) | ||||
| Financing activities | (403 | ) | 23,068 | |||||
| Effect of exchange rate changes on cash and cash equivalents | 2 | - | ||||||
| Net increase (decrease) in cash, cash equivalents and restricted cash | $ | (50,296 | ) | $ | 13,478 | |||
Operating Activities
For the six months ended September 30, 2022 the net cash used in operating activities was $16.1 million which was primarily due to the Company’s net loss of $24.5 million, which includes $9.3 million of stock-based compensation, $0.9 million increase in accounts payable, $0.5 million of depreciation and amortization and $0.5 million decrease in prepaid expenses (mainly related to prepaid insurance), partially offset by ($2.5) million of the payment of the first tranche of the Circassia settlement and ($0.3) million for inventory purchases.
For the six months ended September 30, 2021 the net cash used in operating activities was $8.9 million which was primarily due to the Company’s net loss of $15.4 million, which includes $0.3 million of depreciation and amortization, non-cash stock-based compensation expense of $2.4 million, a decrease of grants receivable of $0.4 million and an increase of $3.5 million of accounts payable and accrued expenses.
Investing Activities
For the six months ended September 30, 2022 and September 30, 2021, net cash used in investing activities was $33.8 million and $0.7 million, respectively. In the six months ended September 2022, the Company invested $32.6 million of excess cash in high quality, short term, US dollar denominated marketable equities with high liquidity, and $1.2 million for the purchase of property and equipment, including LungFit PH devices. In the six months ended September 30, 2021, the Company invested $0.7 million, mainly for the purchase of property and equipment.
Financing Activities
Net cash used in financing activities for the six months ended September 30, 2022 was $0.4 million, mainly from the $0.6 million payment of loans related to the financing of directors and officers insurance, partially offset by $0.2 million of funds received from issuance of common stock through the 2022 ATM. Net cash provided by financing activities for the six months ended September 30, 2021 was $23.1 million, including $1.0 million from the issuance of common stock related to the stock purchase agreement with Lincoln Park Capital Fund and $22.4 million from the issuance of common stock through the At-The-Market Equity Offering Sales Agreement, partially offset by loan payments of $0.5 million.
Contractual Obligations
There have been no material changes to our contractual obligations since March 31, 2022. For a summary of our contractual obligations, see Item 7 of Part II of our Annual Report on Form 10-K for the year ended March 31, 2022 (the “2022 Annual Report”), filed with the SEC on June 29, 2022.
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Overview
We have not generated any revenue from the sale of products, but now that we have obtained regulatory approval for LungFit® PH, we expect to begin generating revenue in fiscal year 2023. We had an operating cash outflows of $16.1 million for the six months ended September 30, 2022 and we have experienced an accumulated loss of $146.5 million since inception through September 30, 2022. As of September 30, 2022, we had cash and cash equivalents, marketable securities of $62.4 million and $10.1 million restricted cash. We believe that our cash, cash equivalents, and marketable securities as of September 30, 2022 will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 month from the financial reporting date.
Our future capital needs and the adequacy of our available funds beyond one year from the date of filing these unaudited consolidated financial statements will depend on many factors, including, but not necessarily limited to, the cost and time necessary for the development, clinical studies and certification or regulatory approval of our other medical devices, indications as well as the commercial success of our approved product and any product candidates that receive marketing approval by the FDA. We may be required to raise additional funds through the sale of equity or debt securities or through strategic collaborations and/or licensing agreements in order to fund operations until we are able to generate enough product or royalty revenues, if any. Financing may not be available on acceptable terms, or at all, and our failure to raise capital when needed could have a material adverse effect on our strategic objectives, results of operations and financial condition.
On February 4, 2022, we entered into a new 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 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 September 30, 2022, there was a balance of $49.8 million available under the 2022 ATM.
On May 14, 2020, we entered into the New Stock Purchase Agreement with LPC, which replaced the former $20 million purchase agreement with LPC, dated August 10, 2018. The New Stock Purchase Agreement provides for the issuance of up to $40 million of our common stock, which we may sell from time to time in our sole discretion, to LPC over a period of 36 months, subject to the conditions and limitations in the New Stock Purchase Agreement. As of September 30, 2022, there was a balance of approximately $18.1 million available under the New Stock Purchase Agreement.
Our ability to continue to operate beyond the fourth calendar quarter of 2023 will be largely dependent upon the successful commercial launch of LungFit® PH, as well as obtaining partners in other parts of the world, and the raising of additional funds to finance our activities until we are generating cash flow from operations. Further, there are no assurances that we will be successful in obtaining an adequate level of financing for the development and commercialization of our other product candidates.
There are numerous risks and uncertainties associated with the development of our NO delivery system and we are unable to estimate the amounts of increased capital outlays and operating expenses associated with the completion of the research and development of our product candidates.
Our future capital requirements will depend on many factors, including:
| ● | the effects of the COVID-19 pandemic on our business, the medical community and the global economy; | |
| ● | the progress and costs of our preclinical studies, clinical trials and other research and development activities; | |
| ● | the costs of commercializing the LungFit® system; | |
| ● | 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. |
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ITEM 3. Quantitative and Qualitative Disclosures About Market Risk
We are exposed to market risks in the ordinary course of our business. Market risk represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates. Our market risk exposure is primarily a result of foreign currency exchange rates.
ITEM 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer (our principal executive 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 September 30, 2022.
Changes in Internal Control Over Financial Reporting
During the three months ended September 30, 2022, there were no changes made to our internal controls over financial reporting that materially affected, or that are reasonably likely to materially affect our internal controls over financial reporting.
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PART II OTHER INFORMATION
ITEM 1. Legal Proceedings
See Note 11 to our unaudited condensed consolidated financial statements.
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 2022 Annual Report.
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
ITEM 3. Defaults Upon Senior Securities
None.
ITEM 4. Mine Safety Disclosures
Not Applicable.
ITEM 5. Other Information
None.
| 32 |
ITEM 6. Exhibits.
* Filed herewith.
** Furnished herewith.
| 33 |
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: November 8, 2022 | Steven Lisi |
| President and Chief Executive Officer | |
| (Principal Executive Officer) | |
| /s/ Douglas Larson | |
| Date: November 8, 2022 | Douglas Larson |
| Chief Financial Officer | |
| (Principal Financial and Accounting Officer) |
| 34 |
ATTACHMENTS / EXHIBITS
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