Beyond Air, Inc.

Previous wording

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 shall pay to the University compensation for pre-clinical work over the three-year period from the date of the agreement. Also, the Company will pay to the University a low single-digit royalty on net sales and certain one-time payments based on clinical, regulatory and sales milestones. The Company expects this program to progress from preclinical to a phase 1 first-in-human clinical trial by the end of 2026.

Current wording

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 shall pay to the University compensation for pre-clinical work over the three-year period from the date of the agreement. Also, the Company will pay to the University a low single-digit royalty on net sales and certain one-time payments based on clinical, regulatory and sales milestones. Development timing is under review pending a proposed sale to XTL Biopharmaceutical Ltd.

Previous wording

On March 24, 2025, Beyond Air reorganized its neurology business into a new private company called NeuroNOS Limited (“NeuroNOS”). Beyond Air’s infrastructure, for example regulatory, quality, legal, etc, will continue to support the NeruoNOS team. Beyond Air has 85.7% ownership in NeuroNOS.

Current wording

On March 24, 2025, Beyond Air reorganized its neurology business into a new private company called NeuroNOS Limited (“NeuroNOS”). Beyond Air’s infrastructure, for example regulatory, quality, legal, etc, is currently supporting the NeruoNOS team. Beyond Air has 84.75% ownership in NeuroNOS.

Previous wording

We submitted a PMA supplement to the FDA in November 2023 for the expansion of the label to include certain cardiac surgeries. According to the most recent year-end report from Mallinckrodt Pharmaceuticals (“Mallinckrodt”), sales of NO were $261.4 million in 2024 (down from $303.2 million in 2023) 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 relative sales than in the U.S. We believe the U.S. sales potential of LungFit®PH to be approximately $350 million and worldwide sales potential to be approximately $700 million or greater. We initiated the first phase of our commercial launch in July 2022 (the limited launch phase to introduce Lungfit® PH and Beyond Air to hospitals), and entered into phase 2 (target initial market share gains in certain geographies) with an expanded commercial presence during the spring of 2023 in the U.S. We recently entered the final phase of our launch process where we will equip our commercial organization to become the market leader in the U.S. in a few years. Since receiving CE Mark in late November, 2024, we have received regulatory approvals in Australia, New Zealand, Hong Kong Thailand, Taiwan and Malaysia with our partner Getz Healthcare and are awaiting approvals in several other countries in South East Asia. Additionally, we have signed new distribution agreements covering France, India, Israel, Italy, Japan, Mexico, Morocco, Poland, Romania, Saudi Arabia, and Turkey, among others. We anticipate significant contribution to revenues in fiscal 2026 and beyond from these and future partnerships.

Current wording

We submitted a PMA supplement to the FDA in November 2023 for the expansion of the label to include certain cardiac surgeries. The submission has been withdrawn in favor of our submission of our second generation LungFit PH. According to the most recent year-end report from Mallinckrodt Pharmaceuticals (“Mallinckrodt”), sales of NO were $261.4 million in 2024 (down from $303.2 million in 2023) 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 relative sales than in the U.S. We believe the U.S. sales potential of LungFit®PH to be approximately $350 million and worldwide sales potential to be approximately $700 million or greater. We initiated the first phase of our commercial launch in July 2022 (the limited launch phase to introduce Lungfit® PH and Beyond Air to hospitals), and entered into phase 2 (target initial market share gains in certain geographies) with an expanded commercial presence during the spring of 2023 in the U.S. We recently entered the final phase of our launch process where we will equip our commercial organization to become the market leader in the U.S. in a few years. Since receiving CE Mark in late November, 2024, we have received regulatory approvals in more than 10 other countries outside of the United States and EU. Additionally, we have signed distribution agreements covering 40 countries outside of the United States. We anticipate significant contribution to revenues in fiscal 2026 and beyond from these and future partnerships.

Previous wording

The phase 1a study, between August 2022 and November 2024, enrolled a total of 10 patients treated with either 25,000 ppm or 50,000 ppm NO for a single intra-tumoral administration over 5 minutes. All subjects had significant advanced stage metastatic disease. The mean number of treatments prior to entering the study was 10.3 (min 4, max 18), with 5.5 being medication treatments (min 2, max 14). Tumors were a mix of squamous cell carcinoma, melanoma, breast and triple negative breast. At the time of treatment, life expectancy for all patients was less than 12 months, with some as low as 3 months. The majority of patients are still alive.

Current wording

The phase 1a study, between August 2022 and November 2024, enrolled a total of 10 patients treated with either 25,000 ppm or 50,000 ppm NO for a single intra-tumoral administration over 5 minutes. All subjects had significant advanced stage metastatic disease. The mean number of treatments prior to entering the study was 10.3 (min 4, max 18), with 5.5 being medication treatments (min 2, max 14). Tumors were a mix of squamous cell carcinoma, melanoma, breast and triple negative breast. At the time of treatment, life expectancy for all patients was less than 12 months, with some as low as 3 months. The majority of patients are still alive as of October 1, 2025.

Previous wording

In the first calendar quarter of 2025, NeuroNos, our majority-owned affiliate, raised $2.0 million in a private placement of common shares. An additional $0.5 million was raised in the private placement offering during the third calendar quarter of 2025. In total, the investors purchased a 14.3% equity ownership in NeuroNos, while Beyond Air maintained 85.7% equity ownership. The private placement is closed to investment at this time. The funding is being used to accelerate ongoing preclinical work, including IND-enabling studies as well as for general corporate purposes.

Current wording

In the first calendar quarter of 2025, NeuroNos, our majority-owned affiliate, raised $2.0 million in a private placement of common shares. An additional $0.5 million and $0.2 million was raised in the private placement offering during the third and fourth calendar quarter of 2025, respectively. In total, the investors purchased a 15.25% equity ownership in NeuroNos, while Beyond Air maintained 84.75% equity ownership. The private placement is closed to investment at this time. The funding is being used to accelerate ongoing preclinical work, including IND-enabling studies as well as for general corporate purposes.

Previous wording

A summary of our critical accounting estimates is discussed in the section entitled “Critical Accounting Estimates” inItem 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Form 10-K. There were no material changes to our critical accounting estimates for the six months ended September 30, 2025.

Current wording

A summary of our critical accounting estimates is discussed in the section entitled “Critical Accounting Estimates” inItem 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Form 10-K. There were no material changes to our critical accounting estimates for the nine months ended December 31, 2025.

Previous wording

Below are the results of operations for the three and six months ended September 30, 2025 and September 30, 2024:

Current wording

Below are the results of operations for the three and nine months ended December 31, 2025 and December 31, 2024:

Previous wording

Comparison of Three and Six Months Ended September 30, 2025 with the Three and Six Months Ended September 30, 2024

Current wording

Comparison of Three and Nine Months Ended December 31, 2025 with the Three and Nine Months Ended December 31, 2024

Previous wording

$1.8 million and $0.8 million revenue was recognized for the three months ended September 30, 2025 and September 30, 2024, respectively. Cost of revenue of $2.1 million and gross losses of $0.3 million were recognized for the three months ended September 30, 2025, compared to a cost of revenue of $1.9 million and gross losses of $1.1 million for the three months ended September 30, 2024.

Current wording

Revenue was $2.2 million and $1.1 million for the three months ended December 31, 2025 and December 31, 2024, respectively. Cost of revenue of $1.9 million and gross profit of $0.3 million were recognized for the three months ended December 31, 2025, compared to a cost of revenue of $1.3 million and gross losses of $0.2 million for the three months ended December 31, 2024.

Previous wording

$3.6 million and $1.5 million revenue was recognized for the six months ended September 30, 2025 and September 30, 2024, respectively. Cost of revenue of $3.7 million and gross losses of $0.1 million were recognized for the six months ended September 30, 2025, compared to a cost of revenue of $2.9 million and gross losses of $1.4 million for the six months ended September 30, 2024.

Current wording

Revenue was $5.8 million and $2.6 million for the nine months ended December 31, 2025 and December 31, 2024, respectively. Cost of revenue of $5.6 million and gross profit of $0.2 million were recognized for the nine months ended December 31, 2025, compared to a cost of revenue of $4.2 million and gross losses of $1.6 million for the nine months ended December 31, 2024.

Previous wording

Revenues continue to expand as we continue to sign hospital contracts and begin selling into international markets. The reduction in gross losses is primarily associated with sales growth, partially offset by one-time costs required to upgrade our existing fleet of devices and provisions for excess inventory.

Current wording

Revenues continue to expand as we continue to sign new hospital contracts and begin selling into international markets. The increase in gross profit is primarily associated with sales growth, partially offset by one-time costs required to upgrade our existing fleet of devices and provisions for excess inventory.

Previous wording

Research and development expenses for the three months ended September 30, 2025 were $2.5 million as compared to $4.6 million for the three months ended September 30, 2024. The decrease of $2.1 million was primarily attributed to a decrease in spend in salaries $0.6 million ($0.3 million in Beyond Air and $0.3 million in Beyond Cancer), stock-based compensation costs $0.1 million (less than $0.1 million in Beyond Air and less than $0.1 million in Beyond Cancer), pre-clinical expenses $0.2 million ($0.1 million in Beyond Cancer and $0.1 million in NeuroNos), professional fees $0.2 million ($0.1 million in Beyond Air and $0.1 million in Beyond Cancer), and a reduction in Gen II device development costs of $1.0 million.

Current wording

Research and development expenses for the three months ended December 31, 2025 were $2.4 million as compared to $3.0 million for the three months ended December 31, 2024. The decrease of $0.6 million was primarily attributed to decreases in salaries of $0.4 million ($0.2 million in Beyond Air and $0.3 million in Beyond Cancer, partially offset by increase of $0.1 million in NeuroNos), and a reduction in Gen II device development costs of $1.1 million, partially offset by increased stock-based compensation costs $1.2 million ($1.6 million in Beyond Cancer partially offset by decrease of $0.4 million in Beyond Air).

Previous wording

Research and development expenses for the six months ended September 30, 2025 were $5.5 million as compared to $10.6 million for the six months ended September 30, 2024. The decrease of $5.1 million was attributed primarily to a decrease in spend in salaries $1.9 million ($0.8 million in Beyond Air and $1.1 million in Beyond Cancer), stock compensation costs $0.4 million ($0.2 million in Beyond Air and $0.2 million in Beyond Cancer), pre-clinical expenses $0.6 million ($0.3 million in Beyond Cancer and $0.3 million in NeuroNos), professional fees $0.5 million ($0.3 million in Beyond Air and $0.2 million in Beyond Cancer), travel expenses $0.1 million, depreciation $0.1 million, and a reduction in Gen II device development costs of $1.2 million.

Current wording

Research and development expenses for the nine months ended December 31, 2025 were $8.0 million as compared to $13.6 million for the nine months ended December 31, 2024. The decrease of $5.6 million was attributed primarily to decreases in salaries of $2.4 million ($1.0 million in Beyond Air and $1.5 million in Beyond Cancer, offset by increase of $0.1 million in NeuroNos), pre-clinical expenses $0.7 million ($0.3 million in Beyond Cancer and $0.4 million in NeuroNos), professional fees $0.5 million ($0.4 million in Beyond Air and $0.3 million in Beyond Cancer, partially offset by increase of $0.2 million in NeuroNos), and a reduction in Gen II device development costs of $2.3 million, partially offset by increased stock-based compensation costs $0.7 million ($1.4 million in Beyond Cancer partially offset by decrease of $0.7 million in Beyond Air)

Previous wording

Selling, general and administrative expenses for the three months ended September 30, 2025 were $4.9 million as compared to $7.2 million for the three months ended September 30, 2024. The decrease of $2.3 million was attributed primarily to a decrease in spend in salaries $0.6 million ($0.4 million in Beyond Air and $0.2 million in Beyond Cancer), stock-based compensation costs $1.3 million ($0.6 million in Beyond Air and $0.8 million in Beyond Cancer), $0.3 million of legal fees and $0.1 million of facility expenses, partially offset by an increase of $0.1 million in royalties.

Current wording

Selling, general and administrative expenses for the three months ended December 31, 2025 were $4.5 million as compared to $7.7 million for the three months ended December 31, 2024. The decrease of $3.3 million was attributed primarily to decreases in salaries $0.6 million ($0.4 million in Beyond Air and $0.2 million in Beyond Cancer), stock-based compensation costs $2.1 million ($1.5 million in Beyond Air and $0.7 million in Beyond Cancer), professional fees $0.2 million, and legal fees $0.2 million, partially offset by an increase of $0.1 million in royalties.

Previous wording

Selling, general and administrative expenses for the six months ended September 30, 2025 were $9.6 million as compared to $14.4 million for the six months ended September 30, 2024. The decrease of $4.8 million was attributed primarily to a decrease in spend in salaries $1.4 million ($1.1 million in Beyond Air and $0.3 million in Beyond Cancer), stock-based compensation costs $2.7 million ($1.3 million in Beyond Air and $1.5 million in Beyond Cancer, partially offset by reduction of $0.1 million in NeuroNos), $0.4 million of legal fees, $0.1 million marketing and advertising costs for Beyond Air, $0.1 million travel expenses, and $0.1 million of facility expenses, partially offset by an increase of $0.2 million in royalties.

Current wording

Selling, general and administrative expenses for the nine months ended December 31, 2025 were $14.1 million as compared to $22.1 million for the nine months ended December 31, 2024. The decrease of $8.0 million was attributed primarily to decreases in salaries $2.0 million ($1.5 million in Beyond Air and $0.5 million in Beyond Cancer), stock-based compensation costs $4.9 million ($2.8 million in Beyond Air and $2.2 million in Beyond Cancer, partially offset by increase of $0.1 million in NeuroNos), $0.6 million of legal fees, $0.3 million travel expenses, and $0.2 million of facility expenses, partially offset by an increase of $0.3 million in royalties.

Previous wording

Other expense for the three months ended September 30, 2025 were $0.6 million as compared to other expense of $1.2 million for the three months ended September 30, 2024. The decrease in expense of $0.6 million was attributed primarily to the prior period loss associated with the partial extinguishment of debt of $0.6 million. The derivative liability was extinguished in the prior year and no fair value measurement of such instrument occurred during the current period. Additionally, the decrease in interest expense of $0.3 million is due to the Company’s current debt facility compared to the debt outstanding in the comparative period.

Current wording

Other expense for the three months ended December 31, 2025 were $1.0 million as compared to other expense of $2.4 million for the three months ended December 31, 2024. The decrease in expense of $1.4 million was attributed primarily to the prior period loss associated with the partial extinguishment of debt of $1.9 million. The derivative liability on the Note was remeasured resulting in a gain of $0.5 million, while there was no fair value measurement of such instrument that occurred during the prior period. The reduction in expenses were partially offset by increase in interest expense of $0.6 million due to the Company’s current debt facilities compared to the debt outstanding in the comparative period. Additionally, the Company recognized $0.3 million more loss on disposal of fixed assets compared to the prior period.

Previous wording

Other expense for the six months ended September 30, 2025 were $1.1 million as compared to other expense of $0.7 million for the six months ended September 30, 2024. The increase in expense of $0.4 million was attributed primarily to the change in fair value of the derivative liability that was extinguished in the prior year and no fair value measurement of such instrument occurred during the current period. Additionally, the decrease in interest expense of $0.7 million is due to the Company’s current debt facility compared to the debt outstanding in the comparative period. The decrease in interest expense is offset by a $0.4 million decrease of dividend and investment income.

Current wording

Other expense for the nine months ended December 31, 2025 were $2.1 million as compared to other expense of $3.1 million for the nine months ended December 31, 2024. The decrease in expense of $1.2 million was attributed primarily to the prior period loss associated with the extinguishment of debt of $2.5 million. This was partially offset by the change in fair value of the prior year derivative liability of $1.3 million gain compared to the gain of $0.5 million associated with the remeasurement of the Note derivative liability that occurred during the current period.

Previous wording

Net loss attributed to non-controlling interests for the three months ended September 30, 2025, was $0.3 million, compared to $0.7 million for the three months ended September 30, 2024. Net loss attributed to non-controlling interests for the six months ended September 30, 2025, was $0.7 million, compared to $1.5 million for the six months ended September 30, 2024. Non-controlling interests represent 20% of the net loss of our Beyond Cancer subsidiary and 11.8% of the net loss of our NeuroNos subsidiary based on the ownership structure during the majority of the reporting periods.

Current wording

Net loss attributed to non-controlling interests for the three months ended December 31, 2025, was $0.3 million, compared to $0.3 million for the three months ended December 31, 2024. Net loss attributed to non-controlling interests for the nine months ended December 31, 2025, was $1.0 million, compared to $1.8 million for the nine months ended December 31, 2024. Non-controlling interests represent 20% of the net loss of our Beyond Cancer subsidiary and the applicable ownership structure during each quarterly reporting period of the net loss of our NeuroNos subsidiary.

Previous wording

Net loss attributed to common stockholders of Beyond Air, Inc for the three months ended September 30, 2025, was $7.9 million or a loss of $1.25 per share, basic and diluted. Our net loss attributed to common stockholders of Beyond Air, Inc for the three months ended September 30, 2024 was $13.4 million or a loss of $5.67 per share, basic and diluted.

Current wording

Net loss attributed to common stockholders of Beyond Air, Inc for the three months ended December 31, 2025, was $7.3 million or a loss of $0.85 per share, basic and diluted. Our net loss attributed to common stockholders of Beyond Air, Inc for the three months ended December 31, 2024 was $13.0 million or a loss of $2.96 per share, basic and diluted.

Previous wording

Net loss attributed to common stockholders of Beyond Air, Inc for the six months ended September 30, 2025, was $15.5 million or a loss of $2.75 per share, basic and diluted. Our net loss attributed to common stockholders of Beyond Air, Inc for the six months ended September 30, 2024 was $25.6 million or a loss of $10.99 per share, basic and diluted.

Current wording

Net loss attributed to common stockholders of Beyond Air, Inc for the nine months ended December 31, 2025, was $23.0 million or a loss of $3.44 per share, basic and diluted. Our net loss attributed to common stockholders of Beyond Air, Inc for the nine months ended December 31, 2024 was $38.6 million or a loss of $12.77 per share, basic and diluted.

Previous wording

Below is a summary of our cash flows activities for the six months ended September 30, 2025 and September 30, 2024:

Current wording

Below is a summary of our cash flows activities for the nine months ended December 31, 2025 and December 31, 2024:

Previous wording

For the six months ended September 30, 2025 the net cash used in operating activities was $9.0 million which was primarily due to our net loss of $16.3 million, which includes $3.4 million of stock-based compensation, $1.6 million of depreciation and amortization, and $1.0 million of paid in kind interest and amortization of debt discount associated with the Loan Agreement, in addition to $0.9 million in prepayments and other assets.

Current wording

For the nine months ended December 31, 2025 the net cash used in operating activities was $13.2 million which was primarily due to our net loss of $23.9 million, which includes $4.9 million of stock-based compensation, $2.4 million of depreciation and amortization, and $1.3 million of paid in kind interest associated with the Loan Agreement, $0.5 million provision for inventory losses, and $0.4 million loss on disposal of fixed assets, in addition to $0.9 million in prepayments and other assets.

Previous wording

For the six months ended September 30, 2024 the net cash used in operating activities was $23.5 million which was primarily due to our net loss of $27.1 million, which includes $6.6 million of stock-based compensation, $0.4 million received in grant payments, $1.5 million of depreciation and amortization, $3.9 million of accrued expenses (which included ($4.5) million of the payment of the final tranche of the Circassia settlement and ($2.9) million for the Hudson Bay settlement and ($7.6) million attributable to the resolution ofEmpery Asset Master, Ltd. Et AL, vs AIT Therapeutics Inc.)

Current wording

For the nine months ended December 31, 2024, the net cash used in operating activities was $31.2 million which was primarily due to our net loss of $40.4 million, which includes $9.0 million of stock-based compensation, $2.5 million costs related to the extinguishment of the Loan and Security agreement with Avenue Capital Management II, L.P., as administrative agent and collateral agent, Avenue Venture Opportunities Fund, L.P. and Avenue Venture Opportunities Fund II, L.P. $2.2 million of depreciation and amortization, $1.6 million in prepayments and other assets, $0.9 million in amortization of debt discount, offset by $ 4.5 million of accrued expenses (which included ($4.5) million of the payment of the final tranche with Circassia Limited and its affiliates and ($2.9) million for the Hudson settlement and ($7.6) million attributable to the resolution of Empery Asset Master, Ltd. Et AL, vs AIT Therapeutics Inc.), and $1.6 million change in the fair value of the warrant and derivative liabilities.

Previous wording

For the six months ended September 30, 2024, net cash provided by investing activities was $19.3 million which was mainly attributable to a net redemption of investments in marketable securities of $23.1 million and invested $3.8 million for the purchase of property and equipment, mainly LungFit PH devices.

Current wording

For the nine months ended December 31, 2025, net cash used in investing activities was $3.2 million which was mainly attributable to a net purchase of investments in marketable securities of $2.7 million and invested $0.5 million for the purchase of property and equipment, mainly LungFit PH devices.

Previous wording

For the six months ended September 30, 2025, net cash provided by investing activities was $0.8 million which was mainly attributable to a net redemption of investments in marketable securities of $1.3 million and invested $0.4 million for the purchase of property and equipment, mainly LungFit PH devices.

Current wording

For the nine months ended December 31, 2024, net cash provided by investing activities was $12.3 million which was mainly attributable to a net redemption of investments in marketable securities of $16.7 million and invested $4.4 million for the purchase of property and equipment, mainly LungFit PH devices.

Previous wording

Net cash provided by financing activities for the six months ended September 30, 2025 was $13.0 million, mainly from the issuance of common stock in connection with the At-The-Market Offering Sales Agreement with BTIG, Inc (the “2025 ATM”) of $8.1 million in addition to $3.0 million from the issuance of common stock in connection with the warrant inducement and issuance of additional warrants. Additionally, the Company received $2.0 million of advanced financing from a related party, a director of the Company who is also an existing lender under its Loan Agreement. The Company is currently arranging the terms and expects that such financing will be issued on terms and conditions materially consistent with those of the Loan Agreement.

Current wording

Net cash provided by financing activities for the nine months ended December 31, 2025 was $24.2 million, mainly from the issuance of common stock in connection with the At-The-Market Offering Sales Agreement with BTIG, Inc (the “2025 ATM”) of $8.1 million in addition to $3.0 million from the issuance of common stock in connection with the warrant inducement and issuance of additional warrants. Additionally, the Company received $2.0 million of Additional Loans from a related party, a director of the Company who is also an existing lender under its Loan Agreement. Further, the Company entered into the Note Purchase Agreement with Streeterville, which provided for the issuance of the Note in the principal amount of $12.0 million, partially offset by $1.0 million of fees paid at closing.

Previous wording

Net cash provided by financing activities for the six months ended September 30, 2024 was $21.4 million, mainly from the issuance of securities through securities purchase agreements which the net proceeds were $19 million, $7.5 million advance payment on loan and security agreement, and the issuance of common stock in connection with the At-The-Market Offering Sales Agreement with Truist Securities, Inc (the “2022 ATM”) of $0.6 million partially offset by $5.7 million from the payment of short-term loans, including a $5.0 million partial repayment to Avenue Capital.

Current wording

Net cash provided by financing activities for the nine months ended December 31, 2024 was $12.1 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 the At-The-Market Offering Sales Agreement with Truist Securities, Inc (the “2022 ATM”) of $0.6 million partially offset by $18.7 million from the payment of short-term loans, including a $17.5 million repayment to Avenue Capital.

Previous wording

We have generated revenue of $8.5 million from the sale of products to date. We had an operating cash flow decrease of $9.0 million for the six months ended September 30, 2025 and we have experienced an accumulated loss of $302.0 million since inception through September 30, 2025. As of September 30, 2025, we had cash, cash equivalents and marketable securities of $10.7 million and $0.2 million in restricted cash.

Current wording

We have generated revenue of $10.7 million from the sale of products to date. We had an operating cash flow decrease of $13.2 million for the nine months ended December 31, 2025 and we have experienced an accumulated loss of $309.3 million since inception through December 31, 2025. As of December 31, 2025, we had cash, cash equivalents and marketable securities of $11.7 million and $6.2 million in restricted cash.

Previous wording

On November 1, 2024, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) for a secured loan with certain lenders, including its Chief Executive Officer Steven Lisi and director Robert Carey, for an aggregate principal balance of $11.5 million. The Loan Agreement was approved by each of the Company’s independent and disinterested directors, following the receipt of a recommendation from an independent investment bank. The Loan Agreement provides for the following terms: (i) principal amount of $11,500,000; (ii) ten-year term; (iii) interest of 15% per annum, of which 3% shall be payable in cash and 12% payable in kind through June 30, 2026 and thereafter all in cash; (iv) a royalty interest of 8% of the Company’s net sales on a quarterly basis from July 2026 until the facility is repaid in full; (v) the Company’s obligations will be secured by substantially all of the Company’s assets and (vi) the Company issued the lenders warrants to purchase shares of the Company’s common stock at an exercise price, adjusted for the 2025 Reverse Stock Split, of $7.586 per share.

Current wording

On November 1, 2024, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) for a secured loan with certain lenders, including its Chief Executive Officer Steven Lisi and director Robert Carey, for an aggregate principal amount of $11.5 million. The Loan Agreement was approved by each of the Company’s independent and disinterested directors, following the receipt of a recommendation from an independent investment bank. The Loan Agreement provides for the following terms: (i) principal amount of $11,500,000; (ii) ten-year term; (iii) interest of 15% per annum, of which 3% shall be payable in cash and 12% payable in kind through June 30, 2026 and thereafter all in cash; (iv) a royalty interest of 8% of the Company’s net sales on a quarterly basis from July 2026 until the facility is repaid in full; (v) the Company’s obligations will be secured by substantially all of the Company’s assets and (vi) the Company issued the lenders warrants to purchase shares of the Company’s common stock at an exercise price, adjusted for the 2025 Reverse Stock Split, of $7.586 per share.

Previous wording

On June 2, 2025, the Company received $2.0 million of advanced financing from a director that is also an existing lender under its Loan Agreement. On November 3, 2025, the Company amended and restated the original Loan Agreement (as amended, the “Amended Loan Agreement”) to provide for and finalize the terms of the $2.0 million Additional Loans and the issuance of new five-year warrants to purchase up to 512,821 shares of the Company’s common stock (the “Supplemental Warrants”) with an exercise price of $1.95 per share and subject to the same terms and conditions applicable to the existing warrants issued under the original Loan and Security Agreement (the “2024 Debt Warrants”). Concurrently, the parties entered into a waiver agreement pursuant to which the Lender consented to the Company’s issuance of the Note in exchange for reducing the exercise price of the 2024 Debt Warrants from $7.59 per share to $1.95 per share.

Current wording

On June 2, 2025, the Company received $2.0 million of advanced financing from a director that is also an existing lender under its Loan Agreement. On November 3, 2025, the Company amended and restated the original Loan Agreement (as amended, the “Amended Loan Agreement”) to provide for and finalize the terms of the $2.0 million Additional Loans and the issuance of new five-year warrants to purchase up to 512,821 shares of the Company’s common stock (the “Supplemental Warrants”) with an exercise price of $1.95 per share and subject to the same terms and conditions applicable to the existing warrants issued under the original Loan Agreement (the “2024 Debt Warrants”). Concurrently, the parties entered into a waiver agreement pursuant to which the Lender consented to the Company’s issuance of the Note in exchange for reducing the exercise price of the 2024 Debt Warrants from $7.59 per share to $1.95 per share.

Previous wording

The recent $2.5 million funding for NeuroNOS is closed at this time.

Current wording

The recent $2.7 million funding for NeuroNOS is closed at this time.

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

Our ability to continue to operate beyond the second fiscal quarter of 2027 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 fourth fiscal quarter of 2027 will be largely dependent upon the successful commercial launch of LungFit® PH, obtaining partners in other parts of the world, the timing of the FDA approval for LungFit PH 2 and possibly 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.