Beyond Air Inc Stock Price, News & Analysis

Beyond Air (NASDAQ: XAIR) announced FDA approval for its LungFit® PH system for treating hypoxic respiratory failure in neonates on June 28, 2022. The U.S. commercial launch has begun, with a CE Mark expected later this year. The company presented positive data on high-concentration nitric oxide therapies at multiple conferences, showing safety and efficacy in various patient groups. Financially, XAIR reported a net loss of $44.1 million for the fiscal year ending March 31, 2022, an increase from the previous year's loss of $22.9 million. Cash on hand stands at $80.2 million.

Beyond Air announced FDA approval for LungFit® PH, the first nitric oxide generator for treating term and near-term neonates with hypoxic respiratory failure. This innovative device uses ambient air to produce unlimited, on-demand nitric oxide, thus eliminating the need for traditional gas tanks, reducing logistical burdens for healthcare providers. The commercial launch is set for the first half of 2023. The company claims this advancement validates their Ionizer™ technology, which may lead to future product approvals targeting various respiratory diseases.

Beyond Air (NASDAQ: XAIR) has rescheduled its financial results announcement for the fiscal fourth quarter and year ending March 31, 2022, to June 28, 2022. The management team will host a conference call and webcast at 4:30 PM ET on the same day. Beyond Air is focused on developing inhaled nitric oxide for respiratory conditions and ultra-high concentration nitric oxide for solid tumors. The LungFit® system is pivotal for treating pulmonary diseases and is currently in clinical trials for various lung infections, including acute viral pneumonia.

Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. (NASDAQ: XAIR), has appointed Dr. Jedidiah Monson as Chief Medical Officer, effective June 1, 2022. Dr. Monson, a board-certified radiation oncologist with over 25 years of experience, will oversee the first-in-human trial of ultra-high concentration nitric oxide (UNO) therapy for solid tumors in Israel, slated to begin mid-2022. The company aims to leverage UNO therapy's potential anti-cancer properties to improve treatment outcomes for patients with solid tumors, amidst growing anticipation in the oncology field.

Beyond Air, Inc. (NASDAQ: XAIR) announced positive interim data from the LungFit® GO pilot study for at-home treatment of severe nontuberculous mycobacterial lung disease. A total of 2,323 inhalations were self-administered by 15 subjects, demonstrating high treatment compliance and no related discontinuations. The study showed that all participants successfully titrated to a target of 250 ppm NO without requiring dose reductions. Results indicate strong safety profiles and improvements in quality of life metrics, particularly for NTM symptoms.

Beyond Cancer, an affiliate of Beyond Air (NASDAQ: XAIR), has appointed Susan Howell Jones as Chief Financial Officer. Jones brings over 30 years of financial experience, including significant roles in the bioscience sector. She was pivotal in a $4B acquisition at BASF and significantly increased revenues at Summit Agro USA. The company is poised to begin its first-in-human trial for its innovative ultra-high concentration nitric oxide (UNO) therapy targeting solid tumors. This strategic appointment is expected to enhance the company’s financial leadership during a critical growth phase.

Beyond Air, Inc. (NASDAQ: XAIR) will report its financial results for the fiscal fourth quarter and year ending March 31, 2022, on June 16, 2022, at 4:30 PM ET. The company focuses on developing inhaled nitric oxide for respiratory conditions. Key products include the LungFit® system, aimed at treating severe lung infections and pulmonary hypertension. Management will host a conference call to discuss results and future plans. Investors are encouraged to attend the live webcast for updates.

Beyond Air (NASDAQ: XAIR) announced positive long-term safety data for high concentration inhaled nitric oxide (NO) for treating bronchiolitis, presented at the Pediatric Academic Societies 2022 Meeting. The multi-center study followed 198 infants from pilot studies between 2012-2020, with 101 infants in long-term follow-up. Results indicated no treatment-related serious adverse events and a favorable trend in re-hospitalization rates for the inhaled NO group compared to control. A pivotal study using the LungFit® Pro system is expected to commence in Q4 2023.

Beyond Air, Inc. (NASDAQ: XAIR) announced positive results from a pilot study evaluating the safety and efficacy of inhaled nitric oxide (NO) in patients hospitalized with community-acquired viral pneumonia, including COVID-19. The study, conducted in Israel, involved 40 participants and demonstrated that patients receiving inhaled NO experienced shorter durations of oxygen support and a trend toward reduced hospital stays compared to the control group. No treatment-related adverse events were reported, affirming the safety of inhaled NO as a potential therapeutic option.