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, a medical device and biopharmaceutical company, will report its financial results for the third fiscal quarter ending December 31, 2022, on February 9, 2023. The announcement comes as the company focuses on developing inhaled nitric oxide for treating respiratory conditions and ultra-high concentration nitric oxide for solid tumors through its affiliate, Beyond Cancer. A conference call will be held at 4:30 PM ET the same day to discuss these results. Beyond Air has received FDA approval for its LungFit PH system, targeting persistent pulmonary hypertension of the newborn, and is advancing other clinical trials.
Beyond Cancer, an affiliate of Beyond Air (NASDAQ: XAIR), published pre-clinical data showing that ultra-high concentrations of nitric oxide (UNO) significantly enhance immune responses against solid tumors. The study indicated that UNO-treated mice exhibited improved survival rates and reduced tumor metastasis. These findings were detailed in the journal Cancer Cell International. The research supports the potential of UNO as an innovative treatment for solid tumors, with a first-in-human Phase 1 trial already in progress.
Beyond Air, Inc. (NASDAQ: XAIR) announced that Steve Lisi, its Chairman and CEO, will present at the Piper 34th Annual Healthcare Conference from November 29 to December 1, 2022, in New York, NY. Lisi's presentation is scheduled for November 30, 2022, from 1:10 – 1:30 PM ET. Beyond Air specializes in developing inhaled nitric oxide for respiratory conditions and ultra-high concentration nitric oxide for solid tumors. The company has FDA approval for its LungFit PH system aimed at treating persistent pulmonary hypertension in newborns.
Beyond Cancer, Ltd., a subsidiary of Beyond Air (NASDAQ: XAIR), announced promising in vivo data demonstrating that their ultra-high concentration nitric oxide (UNO) therapy combined with anti-PD-1 treatment significantly improves tumor regression rates and survival in CT26 tumor-bearing mice. This data, presented at the 37th Annual SITC Meeting in Boston, highlights the potential of UNO therapy not only to treat primary tumors but also to address metastatic disease effectively. The findings suggest a strong rationale for further advancing clinical studies in combination with immune checkpoint therapies.
Beyond Air reported its financial results for the fiscal quarter ending September 30, 2022, highlighting a net loss of $12.8 million, or ($0.40) per share. This marks an increase in loss compared to $8.7 million, or ($0.36) per share, in the same quarter last year. R&D expenses rose to $4.5 million, up from $2.8 million, driven by spending on ultra-high concentration nitric oxide (UNO). Despite a total cash burn of $10.4 million, the company has $72.5 million in cash and securities. Beyond Air is advancing its LungFit PH commercial launch and plans further studies in various respiratory conditions.
Beyond Air, Inc. (NASDAQ: XAIR) announced positive results from its LungFit PRO pilot study for treating Viral Community-Acquired Pneumonia (VCAP) with inhaled nitric oxide (NO). The study demonstrated a statistically significant reduction in the duration of oxygen support for patients treated with 150 ppm NO compared to standard supportive treatment. Safety data indicated no treatment-related adverse events. These findings support the efficacy and safety of high-concentration NO in pneumonia treatment, particularly for COVID-19 patients, and highlight Beyond Air's commitment to advancing this therapy.
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.
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