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Beyond Air Inc

For the period ended Dec 31, 2023. Filed Feb 12, 2024.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Dec 31, 2023 · Filed Feb 12, 2024

XAIR$2.29+5.8%Stored close · as of Nov 9, 2026

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Notes to Condensed Consolidated Financial Statements

NOTE 1 ORGANIZATION AND BUSINESS

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

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

LungFit®can be used to treat patients on ventilators that require NO, as well as patients with chronic or acute severe lung infections via delivery through a breathing mask or similar apparatus. Furthermore, the Company believes that there is a high unmet medical need for patients suffering from certain severe lung infections that the LungFit®platform can potentially address. The Company’s other areas of focus with the LungFit®platform beyond PPHN are viral community-acquired pneumonia (“VCAP”) including COVID-19, bronchiolitis (“BRO”), nontuberculous mycobacteria (“NTM”) lung infection and those with various severe lung infections with underlying chronic obstructive pulmonary disease (“COPD”).

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

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

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

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

**NOTE 2 SIGNIFICANT ACCOUNTING POLICIES AND OTHER RISKS AND UNCERTAINTIES **

Basis of Presentation

The unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”) for interim financial information and with the instructions to the Form 10-Q. Accordingly, they do not include all the information and footnotes required to be presented for complete financial statements. The accompanying unaudited condensed consolidated financial statements reflect all adjustments (consisting only of normal recurring items) which are, in the opinion of management, necessary for a fair presentation of the results for the interim periods presented. The accompanying unaudited condensed consolidated balance sheet as of December 31, 2023 has been derived from the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended March 31, 2023 (the “2023 Annual Report”), filed with the U.S. Securities and Exchange Commission on June 22, 2023. The unaudited condensed consolidated financial statements and related disclosures should be read in conjunction with the Company’s audited consolidated financial statements and the related notes thereto included in the 2023 Annual Report.

Principles of Consolidation

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

**Reclassifications **

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

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses for the reporting period. Actual results could differ from those estimates. On an ongoing basis, the Company evaluates its significant estimates including accruals for expenses under consulting, licensing agreements, and clinical trials, stock-based compensation, contingency recognition and the determination of deferred tax attributes and the valuation allowance thereon.

Liquidity Risks and Uncertainties

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

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

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

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

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

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

Other Risks and Uncertainties

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

The Company’s products require approval or clearance from the FDA prior to commencement of commercial sales in the United States. There can be no assurance that the Company’s products beyond LungFit® PH in the U.S. will receive the required approvals or clearances. Certifications, approvals or clearances are also required in foreign jurisdictions in which the Company may license or sell its products. If the Company is denied such certifications or approvals or clearances or such certifications, approvals or clearances are delayed, such denial or delay may have a material adverse impact on the Company’s results of operations, financial position and liquidity. Further, there can be no assurance that the Company’s product will be accepted in the marketplace, nor can there be any assurance that any future products can be developed or manufactured at an acceptable cost and with appropriate performance characteristics, or that such products will be successfully marketed, if at all.

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

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

Fair Value Measurements

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

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

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

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

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

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

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

(in thousands) · Total · Level 1 · Level 2 · Level 3
Marketable securities :
Corporate debt securities · $ · - · $ · - · $ · - · $ · -
Government securities12,90312,903--
Mutual funds10,38810,338--
Total assets measured and recorded at fair value$23,292$23,292$-$-
Liabilities :
Warrant liability$192$-$-$192
Derivative liability214--214
Total liabilities measured and recorded at fair value$406$-$-$406

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

(in thousands) · Total · Level 1 · Level 2 · Level 3
Marketable securities :
Corporate debt securities$1,597$1,597$-$-
Government securities1,0131,013--
Mutual funds14,11414,114--
Total assets measured and recorded at fair value$16,724$16,724$-$-
Liabilities :
Warrant liability$-$-$-$-
Derivative liability----
Total liabilities measured and recorded at fair value$-$-$-$-

Level 3 Valuation

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

WarrantsDerivative
Expected term (in years)4.53.5
Volatility81%81%
Risk-free rate3.88%3.97%

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

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

Warrant Liability

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

***Derivative Liability ***

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

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

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

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

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

(in thousands) · December 31, 2023 · March 31, 2023
Cash and cash equivalents$7,971$29,158
Restricted cash2317,610
Total cash, cash equivalents and restricted cash$8,202$36,768
Marketable securities:
Marketable debt securities--
Corporate debt securities$-$1,597
U.S. government securities12,9031,013
Mutual fund (ultra-short-term income)10,38814,114
Total marketable securities$23,292$16,724
Total cash, cash equivalents, marketable securities and restricted cash$31,494$53,492

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

(in thousands)Fair ValueUnrealized Gains and (Losses)
Corporate debt securities · $ · - · $ · -
U.S. government securities12,90379
Mutual fund (ultra-short-term income)10,38820
Total short-term marketable securities$23,292$99

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

(in thousands)Fair ValueUnrealized Gains and (Losses)
Corporate debt securities$1,597$2
U.S. government securities1,01310
Mutual fund (ultra-short-term income)14,114-
Total short-term marketable securities$16,724$12

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

Revenue Recognition

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

The Company will be required to use judgment to determine (a) the number of performance obligations based on the determination under step (ii) above and whether those performance obligations are distinct from other performance obligations in the contract (b) the transaction price under step (iii) above and (c) the stand-alone selling price for each performance obligation identified in the contract for the allocation of the transaction price in step (iv) above. The Company will also be required to use judgment to determine whether variable consideration should be included in the transaction price. The transaction price is allocated to each performance obligation on an estimated stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under contract are satisfied.

Segment Reporting

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

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

(in thousands) · Beyond Air · Beyond Cancer · Total
Cash, cash equivalents, marketable securities and restricted cash$18,081$13,413$31,494
All other assets19,78163620,417
Total assets$37,862$14,048$51,911
Total liabilities$(27,596)$(844)$(28,440)
Net assets$10,266$13,205$23,471
Non-controlling interest$-$2,657$2,657

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

(in thousands) · Beyond Air · Beyond Cancer · Total
Cash, cash equivalents, marketable securities and restricted cash$32,998$20,494$53,492
All other assets14,70055715,257
Total assets$47,699$21,051$68,749
Total liabilities$(26,201)$(520)$(26,721)
Net assets$21,498$20,530$42,028
Non-controlling interest$-$4,113$4,113

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

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

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

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

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

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

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

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

Research and Development

Research and development expenses are charged to the condensed consolidated statements of operations and comprehensive loss as incurred. Research and development expenses include salaries, benefits, stock-based compensation and costs incurred by outside laboratories, manufacturers, clinical research organizations, consultants, and accredited facilities in connection with preclinical studies and clinical trials. Research and development expenses are partially offset by the benefit of tax incentive payments for qualified research and development expenditures from the Australian tax authority (“AU Tax Rebates”). The Company does not record AU Tax Rebates until payment is received due to the uncertainty of receipt. In the three months ended December 31, 2023 and December 31, 2022, the Company received $0 and $0 thousand, respectively, in AU Tax Rebates. In the nine months ended December 31, 2023 and December 31, 2022, the Company received $0 and $182 thousand, respectively, in AU Tax Rebates.

Stock-Based Compensation

The Company measures the cost of employee and non-employee services received in exchange for an award of equity instruments based on the grant date fair value of the award. Fair value for restricted stock unit awards is valued using the closing price of the Company’s common stock on the date of grant. The grant date fair value is recognized over the requisite service period during which an employee and non-employee is required to provide service in exchange for the award, using the accelerated method with each tranche being expensed over its vesting period. The grant date fair value of employee and non-employee share options is estimated using the Black-Scholes option pricing model. The risk-free interest rate assumptions were based upon the observed interest rates appropriate for the expected term of the equity instruments. The expected dividend yield was assumed to be zero as the Company has not paid any dividends since its inception and does not anticipate paying dividends in the foreseeable future. Starting in 2023, Beyond Air solely used its own historical volatility as the input for expected volatility, but due to Beyond Cancer’s lack of marketability, the Company utilizes the implied volatility based on an aggregate of guideline companies for expected volatility. The Company uses the simplified method to estimate the expected term.

Supplier Concentration

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

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

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

Recently Adopted Accounting Standards

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

Recently Issued Accounting Standards not yet Adopted

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

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

NOTE 3 PROPERTY AND EQUIPMENT

Property and equipment consist of the following:

(in thousands)December 31, 2023March 31, 2023
Clinical and medical equipment$2,041$1,365
Equipment deployable as part of a service offering6,9383,027
Computer equipment869779
Furniture and fixtures532505
Leasehold improvements617581
Property and equipment, gross10,9976,256
Accumulated depreciation(2,446)(1,254)
Property and equipment, net$8,551$5,003

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

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

NOTE 4 STOCKHOLDERS’ EQUITY

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

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

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

Stock Option Plans

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

Restricted Stock Units

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

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

Number Of SharesWeighted Average Grant Date Fair Value
Unvested as of April 1, 20231,101,100$6.78
Granted1,0005.65
Vested(346,900)6.49
Forfeited(6,800)5.06
Unvested as of December 31, 2023748,400$6.92

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

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

NOTE 4 STOCKHOLDERS’ EQUITY (continued)

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

Number of Options · Weighted Average Exercise Price of Options · Weighted Average Remaining Contractual Life of Options · Aggregate Intrinsic Value (in thousands)
Options outstanding as of April 1, 20238,198,881$5.838.4$8,306
Granted132,5003.95--
Exercised(42,500)5.10--
Forfeited(310,787)5.87--
Outstanding as of December 31, 20237,978,094$5.827.4$-
Exercisable as of December 31, 20234,765,344$5.466.4$-

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

Number of Options · Weighted Average Exercise Price of Options · Weighted Average Remaining Contractual Life of Options · Aggregate Intrinsic Value (thousands)
Options outstanding as of April 1, 20233,817,000$2.889.2$23,486
Granted155,0005.50--
Exercised----
Forfeited(142,500)5.33--
Outstanding as of December 31, 20233,829,500$5.508.5$-
Exercisable as of December 31, 20231,349,250$5.508.3$-

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

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

NOTE 4 STOCKHOLDERS’ EQUITY (continued)

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

December 31, 2023December 31, 2022
Risk-free interest rate4.3 – 4.9%2.5 – 4.3%
Expected volatility (Beyond Air)81.4 – 81.7%87.4 - 89.2%
Expected volatility (Beyond Cancer)104.3 – 106.2%104.7-109.1%
Dividend yield0%0%
Expected terms (in years)6.256.25

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

Three Months Ended · Nine Months Ended
December 31,December 31,
(in thousands)2023202220232022
Research and development$1,428$1,290$4,013$3,247
General and administrative5,0074,57614,99711,957
Total stock-based compensation expense$6,435$5,866$19,010$15,204

Warrants

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

Warrant Holders · Number of Warrants · Exercise Price · Intrinsic Value (in thousands) · Date of Expiration
Third-party license agreement208,333$4.80$-January 2024
March 2020 loan172,187$7.26-March 2025
NitricGen agreement80,000$6.90-January 2028
Avenue agreement233,843$5.88-June 2028
Total694,363$6.02$-

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

NOTE 5 OTHER CURRENT ASSETS AND PREPAID EXPENSES

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

December 31, 2023March 31, 2023
Research and development$119$128
Insurance216908
Prepaid rents and tenant improvement49-
Prepaid marketing materials90-
Value added tax receivable240231
Demonstration materials211245
Deposits to secure manufacturing materials5,0192,519
Other174337
Total$6,118$4,369

NOTE 6 ACCRUED EXPENSES

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

December 31, 2023 · March 31, 2023
Research and development$746$426
Professional fees6191,221
Employee salaries and benefits1,247985
Contingent litigation and settlements (Note 10)40010,298
Circassia settlement – current portion (Note 8)4,5003,500
Goods received not invoiced85-
Other285184
Total short-term accrued expenses$7,882$16,613
Circassia settlement – long-term portion (Note 8)$-$4,500
Total other long-term liabilities$-$4,500

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

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

December 31, 2023December 31, 2022
Common stock warrants694,363460,520
Common stock options7,978,0945,645,131
Restricted shares748,400769,500
Loan and Security – conversion feature (Note 10)392,465-
Total9,813,3226,875,151

NOTE 8 LICENSE AGREEMENT

On January 23, 2019, the Company entered into an agreement for commercial rights (the “Circassia Agreement”) with Circassia Limited and its affiliates (collectively, “Circassia”) for PPHN and future related indications at concentrations of < 80 ppm in the hospital setting in the United States and China. On December 18, 2019, the Company terminated the Circassia Agreement.

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

NOTE 9 GRANT COLLABORATION AGREEMENT

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

NOTE 10 COMMITMENTS AND CONTINGENCIES

License Agreements

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

On January 31, 2018, the Company entered into an agreement (the “NitricGen Agreement”) with NitricGen, Inc. (“NitricGen”) to acquire a global, exclusive, transferable license and associated assets including intellectual property, know-how, trade secrets and confidential information from NitricGen related to the LungFit®. The Company acquired the licensing right to use the technology and agreed to pay NitricGen a total of $2.0 million in future payments based upon achieving certain milestones, as defined in the NitricGen Agreement, and single-digit royalties on sales of the LungFit®. The Company paid NitricGen $100 thousand upon the execution of the NitricGen Agreement, $100 thousand upon achieving the next milestone and $1.5 million in January 2023, six months after approval of the LungFit®by the FDA) and issued 100,000 warrants to purchase the Company’s common stock valued at $0.3 million upon executing the NitricGen Agreement. As of December 31, 2023, the remaining future milestone payments total $0.3 million.

Supply Agreement and Purchase Order

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

Contingencies

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

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

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

NOTE 10 COMMITMENTS AND CONTINGENCIES (continued)

Loan and Security Agreement

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

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

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

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

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

NOTE 10 COMMITMENTS AND CONTINGENCIES (continued)

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

Maturity of Long-Term Loan (in thousands)December 31, 2023
2025$1,750
20267,000
20277,000
20281,750
Total$17,500

Components of Loan and Security Agreement

December 31, 2023June 15, 2023 (Closing)
Amount outstanding$17,500$17,500
Debt discount(4,541)(4,541)
Amortization of debt discount779-
Final payment liability613613
Total$14,351$13,572
ContentsView on SEC.gov

The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.