Beyond Air Inc

Previous wording

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

Current wording

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

Previous wording

LungFit®can be used to treat patients on ventilators that require NO, as well as patients with chronic or acute severe lung infections via delivery through a breathing mask or similar apparatus. Furthermore, we believe that there is a high unmet medical need for patients suffering from certain severe lung infections that the LungFit®platform can potentially address. Our current areas of focus with LungFit®are PPHN, viral community-acquired pneumonia (“VCAP”) including COVID-19, bronchiolitis (“BRO”), nontuberculous mycobacteria (“NTM”) lung infection and those with various severe lung infections with underlying chronic obstructive pulmonary disease (“COPD”). Our current product candidates will be subject to premarket reviews and approvals by the FDA, certification through the conduct of a conformity assessment by a notified body in the EU for the product to be CE marked, as well as comparable foreign regulatory authorities.

Current wording

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 of NO at concentrations > 100 parts per million (ppm) 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. The Company’s other areas of focus with the LungFit®platform beyond PPHN are nontuberculous mycobacteria (“NTM”) lung infection and those with various severe lung infections with underlying chronic obstructive pulmonary disease (“COPD”). Our current product candidates will be subject to premarket reviews and approvals by the FDA, certification through the conduct of a conformity assessment by a notified body in the EU for the product to be CE marked, as well as comparable foreign regulatory authorities.

Previous wording

In addition to the above-mentioned programs, we have two subsidiaries that are currently engaging in novel preclinical stage pharmaceutical research, Beyond Cancer, Ltd. and Beyond Air Cyprus.

Current wording

In addition to the above-mentioned programs, we have two subsidiaries that are currently engaging in novel preclinical stage pharmaceutical research, Beyond Cancer and NeuroNos.

Previous wording

As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing purchase orders, open contracts, reconciling payments and invoices and communicating with our personnel and suppliers to identify services that have been performed on our behalf. It also includes the research and development vendors providing us milestone and percentage of completion reports on the statuses within each active purchase order and contract along with estimating the level of service performed and the associated cost incurred for the services when we have not yet been invoiced or otherwise notified of the actual cost. Our vendors invoice us in various ways via advance payments, as contractual milestones are met or monthly in arrears for services performed.

Current wording

As part of the process of preparing our consolidated financial statements, we are required to estimate our accrued research and development expenses. This process involves reviewing purchase orders, open contracts, reconciling payments and invoices and communicating with our personnel and suppliers to identify services that have been performed on our behalf. It also includes the research and development vendors providing us with milestone and percentage of completion reports on the statuses within each active purchase order and contract along with estimating the level of service performed and the associated cost incurred for the services when we have not yet been invoiced or otherwise notified of the actual cost. Our vendors invoice us in various ways via advance payments, as contractual milestones are met, or monthly in arrears for services performed.

Previous wording

$1.2 million and $0 revenue was recognized for the years ended March 31, 2024 and March 31, 2023 respectively. Cost of revenue of $2.5 million and gross losses of $1.3 million were recognized for the year ended March 31, 2024 compared to a cost of revenue of $0.6 million and gross losses of $0.6 million for the year ended March 31, 2023.

Current wording

$3.7 million and $1.2 revenue was recognized for the years ended March 31, 2025 and March 31, 2024 respectively. Cost of revenue of$5.4 million and gross losses of$1.7 million were recognized for the year ended March 31, 2025 compared to a cost of revenue of $2.5 million and gross losses of $1.3 million for the year ended March 31, 2024.

Previous wording

The increase in revenue was due to our commercial product launch in June 2022. Cost of revenue exceeded revenue primarily driven by costs of supply chain infrastructure required to grow revenue in future periods and depreciation of devices purchased but not yet deployed.

Current wording

The increase in revenue was due to additional hospital contracts in the United States market. Cost of revenue exceeded revenue primarily driven by costs of supply chain infrastructure required to grow revenue in future periods and depreciation of additional LungFit® devices purchased in the year.

Previous wording

Net other expense for the year ended March 31, 2024 and March 31, 2023 were $1.3 million and $7.3 million, respectively. The $6.0 million decrease in expenses is mainly due to a change in fair value of warrant liability of $0.6 million on the Loan and Security Agreement, $1.1 million of interest and dividend income from our investments in marketable securities and $7.9 million incurred in the prior year related to the Empery Suit and Hudson suit, partially offset by an increase in interest and finance expense of $2.9 million, and $0.6 million of non-product related litigation.

Current wording

Other expenses for the year ended March 31, 2025 and March 31, 2024, was $3.9 million and of $1.3 million, respectively. The $2.6 million increase in expense is mainly due to a loss on the extinguishment of debt of $2.4 million, a decrease in interest and dividend income from our investments in marketable securities of $1.0 million, a loss in disposal of fixed assets of $0.2 million, an impairment of fixed assets $0.5 million and a change in the fair value of warrant liability of $0.4 million on the Loan and Security Agreement, offset by a decrease of $0.6 million of non-product related litigation and change in fair value of the derivative liability of $1.3 million on the Loan and Security Agreement.

Previous wording

Net loss attributed to non-controlling interest for the year ended March 31, 2024, was $4.1 million, compared to $3.6 million for the year ended March 31, 2023. Non-controlling interest represents 20% of the net loss of our Beyond Cancer subsidiary which was established in November 2021 and the increase in net loss is reflective of the increase in spend in Beyond Cancer since its inception in late 2021.

Current wording

Net loss attributed to non-controlling interest for the year ended March 31, 2025, was $1.9 million for the year ended March 31, 2025, compared to $4.1 million for the year ended March 31, 2024. Non-controlling interest represents 20% of the net loss of our Beyond Cancer subsidiary and 11.76% of the net loss of our NeuroNos subsidiary. The year-on-year variance is due to a decrease in the net loss of Beyond Cancer partially offset by the loss in NeuroNos, which the non-controlling interest was established in the current fiscal year.

Previous wording

Net loss attributed to common stockholders for the year ended March 31, 2024, was $60.3 million or a loss of $1.82 per share, basic and diluted, as a result of the foregoing. Our net loss attributed to common stockholders for the year ended March 31, 2023, was $55.8 million or a loss of $1.86 per share, basic and diluted.

Current wording

Net loss attributed to common stockholders for the year ended March 31, 2025, was $46.6 million or a loss of $0.69 per share, basic and diluted, as a result of the foregoing. Our net loss attributed to common stockholders for the year ended March 31, 2024, was $60.3 million or a loss of $1.82 per share, basic and diluted.

Previous wording

We started generating costs related to the commercial launch since obtaining regulatory approval for the LungFit® PH at the end of the first quarter of fiscal 2023 and started to generate revenue in the first fiscal quarter of 2024. We have generated $1.1 million from the sale of products to date. We used cash flow in operations of $56.0 million for the year ended March 31, 2024 and we have experienced an accumulated deficit of $239.7 million since inception through March 31, 2024. As of March 31, 2024, we had cash, cash equivalents and marketable securities of $34.5 million and $0.2 million in restricted cash.

Current wording

We have generated revenue of $4.9 million from the sale of products to date. We had an operating cash flow decrease of $38.2 million for the year ended March 31, 2025 and we have experienced an accumulated loss of $286.3 million since inception through March 31, 2025. As of March 31, 2025, we had cash, cash equivalents and marketable securities of $6.9 million and $0.2 million in restricted cash.

Previous wording

Our future capital needs and the adequacy of our available funds will depend on many factors, including, but not necessarily limited to, the cost and time necessary for the development, preclinical studies, clinical trials and certification or regulatory approval of our other medical devices, indications as well as the commercial success of our approved product and any product candidates that receive marketing approval by the FDA. We will be required to raise additional funds through sale of equity or debt securities or through strategic collaborations and/or licensing agreements in order to fund operations until we are able to generate enough product or royalty revenues, if any. Financing may not be available on acceptable terms, or at all, and our failure to raise capital when needed could have a material adverse effect on our strategic objectives, results of operations and financial condition.

Current wording

Our future capital needs and the adequacy of our available funds will depend on many factors, including, but not necessarily limited to, the cost and time necessary for the development, preclinical studies, clinical trials and certification or regulatory approval of our other medical devices, indications as well as the commercial success of our approved product and any product candidates that receive marketing approval by the FDA. We may be required to raise additional funds through sale of equity or debt securities or through strategic collaborations and/or licensing agreements in order to fund operations until we are able to generate enough product or royalty revenues, if any. Financing may not be available on acceptable terms, or at all, and our failure to raise capital when needed could have a material adverse effect on our strategic objectives, results of operations and financial condition.

Previous wording

On May 25, 2021, the Company and Circassia entered into the Settlement Agreement resolving all claims by and between both parties and mutually terminating the Circassia Agreement. Pursuant to the terms of the Settlement Agreement, the Company agreed to pay Circassia $10.5 million in three installments, and the first payment of $2.5 million was triggered upon FDA approval for the LungFit® PH (fixing the Initial Payment Due Date at July 28, 2022). Thereafter, the Company is to pay $3.5 million to Circassia on the first anniversary of the Initial Payment Due Date and $4.5 million on the second anniversary of the Initial Payment Due Date. Additionally, beginning in year three post-approval, Circassia will receive a quarterly royalty payment equal to 5% of LungFit® PH net sales in the U.S. $4.5 million is included in accrued liabilities at March 31, 2024 and will be paid in the second fiscal quarter of 2025.

Current wording

On May 25, 2021, the Company and Circassia entered into a settlement agreement (“the Settlement Agreement”) resolving all claims by and between the parties and mutually terminating the agreement with Circassia disclosed in Note 9 to our financial statements for the fiscal year ended March 31, 2025. Pursuant to the terms of the Settlement Agreement, the Company agreed to pay Circassia $10.5 million in three installments, all of which has been paid. Additionally, beginning in the third fiscal quarter of 2025, Circassia will receive a quarterly royalty payment equal to 5% of LungFit® PH net sales in the U.S. until the final $6.0 million has been paid. As of March 31, 2025, less than $0.1 million of royalty has been paid.

Previous wording

On February 4, 2022, we entered into an At-The-Market Equity Offering Sales Agreement with Truist Securities, Inc. and Oppenheimer & Co, Inc. (the “2022 ATM”). Under the 2022 ATM, we may sell shares of our common stock having aggregate sales proceeds of up to $50.0 million, from time to time and at various prices. If shares of our common stock are sold, there is a 3% fee paid to the sales agent. As of March 31, 2024, there was a balance of $32.9 million available under the 2022 ATM.

Current wording

On February 10, 2025, we entered into the At-The Market Offering Sales Agreement with BTIG, Inc. (the “2025 ATM”). Under the 2025 ATM, we may sell shares of our common stock having aggregate sales proceeds of up to $35.0 million, from time to time and at various prices. Pursuant to the “baby shelf rules” promulgated by the SEC, if our public float is less than $75.0 million as of specified measurement periods, the number of shares of common stock that may be offered and sold by us under a Form S-3 registration statement, including pursuant to the 2025 ATM, in any twelve-month period is limited to an aggregate amount that does not exceed one-third of our public float. As of March 31, 2025, due to the SEC’s “baby shelf rules,” we were permitted to sell up to $6.6 million of shares of common stock pursuant to the 2025 ATM. We will remain subject to the “baby shelf rules” under the Form S-3 registration statement until such time as our public float exceeds $75.0 million. If shares of our common stock are sold, there is a 2.5% fee paid to the sales agent.

Previous wording

Our ability to continue to operate beyond the first fiscal quarter of 2025 will be largely dependent upon the successful commercial launch of LungFit® PH, as well as obtaining partners in other parts of the world, and raising additional funds to finance our activities until we are generating cash flow from operations. Further, there are no assurances that we will be successful in obtaining an adequate level of financing for the development and commercialization of our other product candidates.

Current wording

Our ability to continue to operate beyond the third fiscal quarter of 2026 will be largely dependent upon the successful commercial launch of LungFit® PH, as well as obtaining partners in other parts of the world, and raising additional funds to finance our activities until we are generating cash flow from operations. Further, there are no assurances that we will be successful in obtaining an adequate level of financing for the development and commercialization of our other product candidates.

Previous wording

For the year ended March 31, 2024, net cash used by operating activities was $56.0 million, which was primarily due to our net loss of $64.3 million, which includes $21.3 million of stock-based compensation, $0.4 million received in grant payments, $2.0 million of depreciation and amortization partially offset by a $1.6 million increase in prepaid accounts, a $0.3 million increase in accounts receivable, a $1.0 million increase in inventory, ($3.5) million in payment of the second tranche of a May 2021 settlement with Circassia, ($2.9) million for the Hudson settlement and ($7.6) million attributable to the resolution of the Empery Suit. For the year ended March 31, 2023, net cash used by operating activities was $33.0 million, which was primarily due to our net loss of $59.4 million, which included non-cash stock-based compensation of $19.6 million and an increase in accrued liabilities of $4.8 million including an increase in liabilities related to lawsuits of $7.8 million, partially offset by the payment of the first tranche of the Circassia settlement of $2.5 million.

Current wording

For the year ended March 31, 2025, net cash used by operating activities was $38.2 million, which was primarily due to our net loss of $48.5 million which includes $9.1 million of stock-based compensation, $3.0 million of depreciation and amortization, a non-cash loss of $2.4 million on the extinguishment of debt, an impairment of fixed assets charge $0.5 million, a $0.4 million increase in accounts receivable, a $0.4 million increase in inventory, partially offset by a $1.0 million decrease in prepaid accounts, a decrease in accrued liabilities $6.4 million (which included $4.5 million in payment of the final tranche of a May 2021 settlement with Circassia). For the year ended March 31, 2024, net cash used by operating activities was $56.0 million, which was primarily due to our net loss of $64.3 million, which includes $21.3 million of stock-based compensation, $0.4 million received in grant payments, $2.0 million of depreciation and amortization partially offset by a $1.6 million increase in prepaid accounts, a $0.3 million increase in accounts receivable, a $1.0 million increase in inventory, ($3.5) million in payment of the second tranche of a May 2021 settlement with Circassia, ($2.9) million for the Hudson settlement and ($7.6) million attributable to the resolution of the Empery Suit.

Previous wording

For the year ended March 31, 2024, cash used in investing activities was $12.2 million which was primarily from investments in marketable securities from net proceeds received from the purchase and sale of marketable securities of $6.5 million in the fiscal year, and the purchase of property and equipment for $5.7 million. For the year ended March 31, 2023, cash used in investing activities was $20.6 million which was primarily from investments in marketable securities from net proceeds received from the purchase and sale of marketable securities of $16.7 million in the fiscal year, and the purchase of property and equipment for $3.9 million.

Current wording

For the year ended March 31, 2025, cash provided by investing activities was $14.9 million which was primarily from investments in marketable securities from net proceeds received from the purchase and sale of marketable securities of $20.8 million in the fiscal year, and the purchase of property and equipment for $5.9 million. For the year ended March 31, 2024, cash used in investing activities was $12.2 million which was primarily from investments in marketable securities from net proceeds received from the purchase and sale of marketable securities of $6.5 million in the fiscal year, and the purchase of property and equipment for $5.7 million.

Previous wording

For the year ended March 31, 2024, net cash provided by financing activities was $43.2 million, mainly from the Loan Agreement of which the net proceeds were $15.8 million, the issuance of common stock in connection with the 2022 ATM of $13.4 million, and the registered direct offering (the “Registered Offering”) pursuant to a securities purchase agreement dated March 20, 2024 with Roth Capital Partners, LLC and Laidlaw & Company (UK) Ltd. of $14.6 million***,*** the issuance of common stock in connection with the exercise of options ($0.2 million) partially offset by $0.8 million from the payment of short-term loans. For the year ended March 31, 2023, net cash provided by financing activities was $2.7 million which was primarily from the issuance of common stock in connection with our 2022 ATM for $3.7 million, partially offset by loan payments of $1.0 million.

Current wording

For the year ended March 31, 2025, net cash provided by financing activities was $16.6 million, mainly from the issuance of securities through securities purchase agreements which the net proceeds were $18.8 million, $11.3 million payment received on the loan agreement, and the issuance of common stock in connection with an At-The-Market Offering Sales Agreement with Truist Securities, Inc. (the “2022 ATM”) of $0.7 million and $1.5 million in connection with the 2025 ATM partially offset by $18.0 million from the payment of long- and short-term loans, including a $17.5 million repayment to Avenue Capital. For the year ended March 31, 2024, net cash provided by financing activities was $43.2 million, mainly from the Loan Agreement of which the net proceeds were $15.8 million, the issuance of common stock in connection with the 2022 ATM of $13.4 million, and the registered direct offering (the “Registered Offering”) pursuant to a securities purchase agreement dated March 20, 2024 with Roth Capital Partners, LLC and Laidlaw & Company (UK) Ltd. of $14.6 million***,*** the issuance of common stock in connection with the exercise of options ($0.2 million) partially offset by $0.8 million from the payment of short-term loans.