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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), a commercial stage medical device and biopharmaceutical company, has announced it will report its first fiscal quarter 2025 financial results on Tuesday, August 6, 2024, after the market closes. The company focuses on harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors (through its affiliate Beyond Cancer, ). The financial results will cover the period ended June 30, 2024.
Beyond Air (NASDAQ: XAIR), a commercial stage medical device and biopharmaceutical company, has announced its participation in the BTIG Virtual Biotechnology Conference 2024. The event is scheduled for August 5-6, 2024. Steve Lisi, Chairman and CEO of Beyond Air, will be available for one-on-one meetings during the conference.
Beyond Air focuses on harnessing the power of nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. The company's affiliate, Beyond Cancer, is involved in cancer treatment research. Interested parties can contact their BTIG representative to schedule meetings with the Beyond Air team during the conference.
Beyond Air (NASDAQ: XAIR) reported its financial results for the fiscal fourth quarter and full year 2024, alongside a corporate update. The company appointed David Webster as Chief Commercial Officer and upgraded their LungFit PH device. The device has been utilized in over 50 hospitals, treating more than 1,100 patients. However, FY 2025 revenue guidance was revised to over $10M, down from $12M-$16M. Cost-cutting measures were implemented, reducing headcount by over 20%, and some R&D projects were paused. Net loss for FY 2024 was $60.2M, compared to $55.8M in FY 2023. The company expects to be cash flow positive by Q4 2026 and has $34.5M in cash and equivalents as of March 31, 2024. A conference call is scheduled for June 24, 4:30 PM ET.
Beyond Air, a company specializing in medical devices and biopharmaceuticals, has appointed David Webster as Chief Commercial Officer, effective July 8, 2024. Webster brings over 20 years of executive experience in the life sciences industry, including roles at Body Vision Medical and NeuroLogica. His appointment comes as Beyond Air's product, LungFit PH, is set to lead the nitric oxide (NO) market, with promising customer feedback and market engagement. The company granted Webster an inducement stock option to purchase 125,000 shares, vesting over four years. Webster's expertise is expected to drive significant market share gains for LungFit PH.
Beyond Cancer has revealed promising Phase 1a clinical data for their ultra-high concentration nitric oxide (UNO) platform, showing early tumor responses and immune system activation in subjects with relapsed or refractory unresectable solid tumors.
Data presented at the 2024 American Society of Clinical Oncology Annual Meeting highlighted immune biomarker responses, including increases in dendritic cells, cytotoxic T-cells, and central memory T-cells, along with a decrease of 54% in Myeloid Derived Suppressor Cells (MDSCs) post-treatment.
The Phase 1b trial, combining UNO with anti-PD-1 therapy, has been filed for regulatory approval and aims to enroll up to 20 subjects. UNO was generally well-tolerated, with primarily Grade 1 toxicities and one Grade 3 adverse event noted.
Beyond Air (NASDAQ: XAIR), a commercial-stage medical device and biopharmaceutical company, will announce its fiscal year-end 2024 financial results on June 24, 2024. The company, specializing in nitric oxide therapies for respiratory illnesses, neurological disorders, and solid tumors, will host a conference call and webcast at 4:30 pm ET on the same day. The call can be accessed domestically at 1-877-407-0784 and internationally at 1-201-689-8560 using Conference ID: 13746892. A live and replay webcast will be available on the company's website.
Beyond Cancer, has been chosen to present on the clinical development of Ultra-High Concentration Nitric Oxide (UNO) Therapy at the 2024 American Society of Clinical Oncology Annual Meeting. The company will host an event in Chicago featuring key opinion leaders to discuss the ongoing clinical development of UNO. Additionally, presentations at the ASCO Annual Meeting will showcase new data from the Phase 1 trial evaluating UNO101 in various malignancies.
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