XAIR — what changed in the latest 10-K

Text added vs the prior filing · source: 10-K · 2026-06-26

• 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 th…

• A PMA supplement to the US FDA for the expansion of the label to include certain cardiac surgeries was withdrawn in favor of our submission of our second generation LungFit® PH II. The LungFit® PH II PMA supplement was submitted to the FDA in June 2025. LungFit® PH II is smaller, lighter, and fully …

• Beyond Cancer will benefit from Beyond Air’s NO expertise, IP portfolio, and regulatory progress, and will pay Beyond Air a single-digit royalty on all future revenues.

• 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 …

• A Phase 1b trial protocol was approved by the Israeli Ministry of Health (IMOH) in December 2024. The initiation of the study is pending future funding.

Text removed vs the prior filing · source: 10-K · 2025-06-20

• 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) f…

• Beyond Cancer benefits from Beyond Air’s NO expertise, IP portfolio, preclinical oncology team, and regulatory progress, and will pay Beyond Air a single-digit royalty on all future revenues. Beyond Cancer is being led by a seasoned leadership team with experience in emerging healthcare companies an…

• A Phase 1b trial protocol was approved by the Israeli Ministry of Health (IMOH) in December 2024. This trial will enroll up to 15 subjects with prior exposure to anti-PD-1 antibody that have either progressed, not achieved a response, or have prolonged stable disease (12 weeks) on single agent anti-…

• Work is currently being done by the University in a preclinical setting. We expect this program to progress from preclinical to a phase 1 first-in-human clinical trial by the end of 2026.

• We have conducted several clinical trials to assess our 150-250 ppm NO inhalation-treatment in various indications. These trials include:

Text added vs the prior filing · source: 10-K · 2026-06-26

• Our products may rely on embedded software, digital interfaces, electronic components and interoperability with hospital or clinical infrastructure, including ventilators, monitoring systems and gas-delivery systems. Certain deployments of our systems may operate in limited-connectivity, isolated or…

• Remediation of cybersecurity vulnerabilities affecting our products may require extensive validation, customer coordination, regulatory review or on-site servicing activities, which could delay implementation of corrective measures and increase operational costs.

• Changes in regulatory expectations relating to software-enabled medical devices, cybersecurity, or interoperability may increase our compliance costs, require design modifications, delay approvals or require additional post-market controls.

• ● other countries also have, or are developing, laws governing the collection, use, disclosure and protection of personal information. The GDPR, for example, imposes restrictions on the processing (e.g., collection, use, disclosure) of personal data in the EEA and also imposes strict restrictions on…

• In the year ended March 31, 2026, the Company purchased approximately 74% and 18% of its materials from two third-party vendors. In the year ended March 31, 2025, the Company purchased approximately 85% of its materials from a third-party vendor.

Text removed vs the prior filing · source: 10-K · 2025-06-20

• ● other countries also have, or are developing, laws governing the collection, use, disclosure and protection of personal information. The GDPR, for example, imposes restrictions on the processing (e.g., collection, use, disclosure) of personal data in the EEA and also imposes strict restrictions on…

• In the year ended March 31, 2025, the Company purchased approximately 87% of its materials from a third-party vendor. In the year ended March 31, 2024, the Company purchased approximately 75% of its materials from a third-party vendor.

• 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 reg…

• On August 8, 2024, we received a letter from Nasdaq notifying us that we were no longer in compliance with the $1.00 minimum bid price requirement for continued listing on Nasdaq under the Bid Price Rule. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided an initial period of 18…

• Furthermore, as of June 18, 2025, the closing price of our Common Stock was $0.2023. Pursuant to Nasdaq Rule 5810(c)(3)(A)(iii), if the closing price of our common stock is $0.10 or less for 10 consecutive trading days, we will be issued a Staff Delisting Determination by Nasdaq. If we receive a Sta…

Text added vs the prior filing · source: 10-K · 2026-06-26

• Revenue was $7.7 million and $3.7 for the years ended March 31, 2026 and March 31, 2025 respectively. Cost of revenue of $7.4 million and gross profit of $0.3 million were recognized for the year ended March 31, 2026 compared to a cost of revenue of $5.4 million and gross losses of $1.7 million for …

• 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 exce…

• Research and development expenses for the year ended March 31, 2026 were $10.2 million as compared to $16.9 million for the year ended March 31, 2025. The decrease of $6.7 million was primarily attributed primarily to a decrease in salaries of $2.8 million ($1.5 million in Beyond Air and $1.5 millio…

• Selling, general and administrative expenses for the year ended March 31, 2026 were $19.1 million as compared to $26.0 million for the year ended March 31, 2025. The decrease of $6.9 million was attributed primarily to a decrease in salaries of $1.0 million ($0.6 million in Beyond Air and $0.5 milli…

• Other expense for the year ended March 31, 2026 were $5.3 million as compared to other expense of $3.9 million for the year ended March 31, 2025. The increase in expense of $1.4 million was attributed primarily to the change in fair value of the prior year derivative liability of $1.3 million gain c…

Text removed vs the prior filing · source: 10-K · 2025-06-20

• $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 m…

• 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.

• Research and development expenses for the year ended March 31, 2025 were $16.9 million, as compared to $24.4 million for the year ended March 31, 2024. The decrease of $7.5 million was primarily attributed to a decrease in spend in salaries $1.5 million in Beyond Air, stock-based compensation $4.0 m…

• Selling, general and administrative expenses for the year ended March 31, 2025 and March 31, 2024 were $26.0 million and $37.3 million, respectively. The decrease of $11.3 million was attributed primarily to a decrease in spend in salaries $1.8 million ($2.7 million in Beyond Air offset by an increa…

• 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 mark…