XAIR — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-13

• 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• A PMA supplement to the US FDA for the expansion of the label to include certain cardiac surgeries was withdrawn in favor of our submission of our second generation LungFit® PH II.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.

• 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.

• In April 2025, the FDA granted Orphan Drug Designation (“ODD”) to NeuroNos’ investigational therapy, BA-102, for the treatment of Phelan-McDermid Syndrome (“PMS”), a syndrome associated with ASD. PMS is a rare genetic disorder most commonly caused by deletions or mutations affecting the SHANK3 gene …

Text removed vs the prior filing · source: 10-Q · 2026-02-13

• 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 The submission has been withdrawn in favor of our submission of our second generation LungFit PH.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 Pharmaceutic…

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

• 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-…

• A summary of our critical accounting estimates is discussed in the section entitled “Critical Accounting Estimates” in Item 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 f…

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

Text added vs the prior filing · source: 10-Q · 2026-08-13

• Our failure to maintain our compliance with Nasdaq’s continued listing standards or other requirements could result in our common stock being delisted from Nasdaq, which could adversely affect our liquidity and the trading volume and market price of our common stock and decrease or eliminate your in…

• Our common stock is currently listed on the Nasdaq Capital Market under the symbol “XAIR.” Nasdaq requires listed issuers to comply with certain standards to remain listed on its exchange, and our failure to maintain compliance with Nasdaq’s continued listing standards or other requirements could re…

• On April 7, 2026, 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 under Nasdaq Listing Rule 5550(a)(2), which we refer to as the Bid Price Rule. While companies are typically afforded a 180-calendar…

• On August 6, 2026, Nasdaq notified us in writing that we had regained compliance with the Bid Price Rule. Pursuant to its authority under Nasdaq Listing Rule 5815(d)(4)(A), the Panel determined to impose a Discretionary Panel Monitor for a period of one year from the date of that letter, or until Au…

• Nasdaq Listing Rule 5810(c)(3)(A)(iv) also provides that a company whose security fails to meet the minimum bid price requirement is not eligible for an automatic compliance period if it effected a reverse stock split during the preceding one-year period or effected one or more reverse stock splits …

Text removed vs the prior filing · source: 10-Q · 2026-02-13

• The proposed transaction involving NeuroNOS Ltd. may not be consummated, which could materially and adversely affect our business, financial condition, and the value of our securities.

• We have entered into a binding letter of intent with XTL Biopharmaceuticals Ltd. relating to the proposed acquisition of NeuroNOS Ltd. Completion of the proposed transaction is subject to a number of conditions, including the negotiation and execution of definitive agreements and satisfaction of cus…