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Beyond Air, Inc. (symbol: XAIR) is a clinical-stage medical device and biopharmaceutical company focused on revolutionizing respiratory disease treatments through innovative technology. The company's flagship product is the LungFit™ system, a Nitric Oxide (NO) Generator and Delivery System that uses NO generated from ambient air to deliver precise amounts of NO to the lungs of both ventilated and non-ventilated patients. This breakthrough technology is aimed at treating various pulmonary diseases, including pulmonary hypertension, severe lung infections such as SARS-CoV-2, and nontuberculous mycobacteria (NTM).
LungFit™ can generate up to 400 ppm of NO, offering flexibility in delivery either continuously or for a fixed period. It also features the ability to titrate the dose on demand or maintain a constant dose. This system is currently advancing in clinical trials and has garnered attention for its potential in treating lower respiratory tract infections that are not effectively addressed by current standards of care.
Beyond Air is also exploring ultra-high concentrations of NO with a proprietary delivery system separate from LungFit™ to target certain solid tumors. This preclinical testing aims to offer new hope for cancer treatments, making Beyond Air a pioneer in utilizing NO for diverse therapeutic applications.
Notably, Beyond Air has achieved significant milestones, including FDA approval for its LungFit® PH system designed for treating term and near-term neonates with hypoxic respiratory failure. The company has partnered with The Hebrew University of Jerusalem to develop treatments for neurological disorders like autism spectrum disorder (ASD). In addition, Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating ultra-high concentrations of NO to target specific solid tumors.
Financially, Beyond Air has shown a commitment to growth, as evidenced by its recent increase in general and administrative expenses, primarily driven by stock-based compensation and professional fees. The company maintains a forward-looking stance, aiming to expand its product portfolio and enhance its market position.
For more detailed information on their latest developments and product offerings, visit Beyond Air's official website.
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.
Beyond Air, Inc. (NASDAQ: XAIR) announced its participation in three upcoming medical conferences to present new data on inhaled nitric oxide treatments. At the Pediatric Academic Societies 2022 Meeting, the company will share long-term safety data for high concentration inhaled nitric oxide in treating bronchiolitis on April 25. During the ECCMID 2022, new findings on COVID-19 treatment with a novel nitric oxide generator will be presented on April 23. Lastly, at ATS 2022, new results from the LungFit GO pilot study on high concentration inhaled nitric oxide in NTM will be discussed on May 17.
Beyond Cancer, an affiliate of Beyond Air (NASDAQ: XAIR), announced promising data on its gaseous nitric oxide (gNO) therapy for solid tumors. Presenting at the AACR Annual Meeting 2022, studies showed gNO induced immune cell recruitment and reduced suppressor cells, indicating a potential anti-tumor response. The in vivo study observed increased immune cells and reduced suppression in treated mice, while the in vitro results indicated a dose-dependent cytotoxic effect across several cancer cell lines. A first-in-human study is expected to begin in Q2 2022.
Beyond Air, a clinical-stage company specializing in nitric oxide therapies, announced two important presentations at the AACR Annual Meeting, set for April 8-13, 2022, in New Orleans. They will showcase research on nitric oxide's impact on cancer treatments, particularly a study demonstrating a single injection's ability to elicit an immune response in tumors and another analyzing its cytotoxic effects against various cancer cells. These advancements could change the landscape of therapies for respiratory conditions and solid tumors.