Welcome to our dedicated page for Beyond Air news (Ticker: XAIR), a resource for investors and traders seeking the latest updates and insights on Beyond Air stock.
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) will report its second fiscal quarter financial results for the period ending September 30, 2022, on November 8, 2022, at 4:30 PM ET. The company focuses on developing inhaled nitric oxide for respiratory conditions and has received FDA approval for its LungFit PH system. This conference call will provide insights into the company’s financial performance and future developments.
Beyond Air (NASDAQ: XAIR) announced positive results from its pilot study of the LungFit GO device for treating severe nontuberculous mycobacteria (NTM) lung disease. Conducted with 15 patients, the study demonstrated favorable safety and efficacy, with no dose reductions required during at-home use. Patients maintained high compliance (>90%) and experienced improvements in quality of life. No serious adverse events were reported, and trends indicated a reduction in bacterial load. This study supports the development of intermittent high-dose nitric oxide therapy for NTM.
Beyond Cancer, an affiliate of Beyond Air (NASDAQ: XAIR), announced it will present significant data on its ultra-high concentration nitric oxide (UNO) therapy during the Society for Immunotherapy of Cancer (SITC) Annual Meeting from November 8-12, 2022. The presentation, titled Intratumoral Administration of High-Concentration Nitric Oxide and Anti PD-1 Treatment Leads to Higher Tumor Regression Rates and Prolonged Survival in CT26 Tumor-Bearing Mice, will take place on November 10, 2022. UNO therapy aims to prevent relapse or metastatic disease in solid tumors and shows potential for minimal toxicity.
Beyond Air (NASDAQ: XAIR) announced that the Annals of the American Thoracic Society published results from its third pilot study on inhaled nitric oxide (NO) for treating infants with bronchiolitis. The study showed that administering 150 ppm NO significantly reduced hospital discharge times compared to standard therapies. Despite promising results, the bronchiolitis program is on hold due to pandemic impacts. Future studies on high concentration NO for community-acquired pneumonia are planned for late 2023, pending FDA discussions.
Beyond Air (NASDAQ: XAIR) announced its participation in upcoming healthcare conferences, including the LifeSci Partners HealthTech Symposium on September 20-21, 2022, where Steve Lisi, the CEO, will engage in a fireside chat. Additionally, Lisi will present at the Ladenburg Thalmann Healthcare Conference on September 29, 2022, and the Roth Inaugural Healthcare Opportunities Conference on October 6, 2022. The focus is on Beyond Air's developments in inhaled nitric oxide and its LungFit system, which is designed for treating respiratory conditions and certain solid tumors.
Beyond Cancer, Ltd., an affiliate of Beyond Air (NASDAQ: XAIR), has announced the treatment of the first patient in a Phase 1 study evaluating the safety and immune response of its ultra-high concentration nitric oxide (UNO) therapy for solid tumors. This significant milestone aims to explore the therapy's potential to prevent metastasis and relapse in cancer patients. Initial clinical data is expected in early 2023. The study will assess the maximum tolerated dose, safety, and immune biomarkers, contributing to the development of innovative cancer treatments.
Beyond Air, Inc. (NASDAQ: XAIR) launched LungFit® PH for treating neonates with hypoxic respiratory failure, following FDA approval on June 28, 2022. The company reported a net loss of $11.7 million for the first fiscal quarter ended June 30, 2022, with R&D expenses rising to $3.2 million and general and administrative expenses increasing to $8.2 million. Cash and cash equivalents stand at $72.8 million. Future milestones include a CE Mark expected in H2 2022, and the initiation of clinical trials for LungFit® PRO in late 2023.
Beyond Air, Inc. (NASDAQ: XAIR) will report its financial results for Q1 fiscal 2022 on August 11, 2022. The company specializes in developing inhaled nitric oxide treatments for respiratory conditions and solid tumors. Beyond Air's LungFit® system has received FDA approval for treating persistent pulmonary hypertension in newborns. The management team will host a conference call at 4:30 PM ET on the same day to discuss the results.
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.
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