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, Inc. (NASDAQ: XAIR) announced its financial results for Q3 FY2021, reporting no revenue compared to $0.1 million last year and a net loss of $8 million. They are progressing with the LungFit® PH PMA submission to the U.S. FDA, aiming for approval in H1 2022. The company raised $30 million for its oncology affiliate, Beyond Cancer, retaining 80% equity. Research and development expenses decreased, but general and administrative expenses rose to $4.9 million. Upcoming milestones include data presentations and patient enrollment for key clinical studies scheduled in 2022.
Beyond Air, a clinical-stage medical device and biopharmaceutical company, announced that its CEO, Steve Lisi, will participate in two investor conferences in March 2022. The first event is the 34th Annual Roth Conference from March 13-15, 2022 in Dana Point, California. The second is the Oppenheimer 32nd Annual Healthcare Conference, with a virtual presentation scheduled for March 16, 2022 at 10:00 AM ET. Beyond Air focuses on developing inhaled nitric oxide for respiratory conditions and ultra-high concentration nitric oxide for solid tumors.
Beyond Air, Inc. (NASDAQ: XAIR) has appointed Mr. David Dvorak and Dr. Gregory Berk to the Board of Directors of its affiliate, Beyond Cancer. Dvorak, with over 25 years in healthcare leadership, previously served as CEO of Zimmer Biomet, overseeing significant revenue growth from $1.2 billion to $7.7 billion. Berk brings over 30 years of oncology expertise and currently leads R&D at GT Biopharma. These appointments aim to enhance Beyond Cancer's strategic execution and expedite its ultra-high concentration nitric oxide therapy for solid tumors, with first human studies expected in the first half of this year.
Beyond Air, Inc. (NASDAQ: XAIR) will report its third fiscal quarter financial results, ending December 31, 2021, on February 10, 2022. A conference call is scheduled at 4:30 PM ET for management to discuss results and future developments. The company focuses on inhaled nitric oxide technology for treating respiratory diseases and is progressing its LungFit® system for clinical trials targeting severe lung infections, including COVID-19. For further details, visit www.beyondair.net.
Beyond Air (NASDAQ: XAIR) announced a delay in the U.S. commercial launch of LungFit® PH for persistent pulmonary hypertension of the newborn (PPHN), which will not occur before December 31, 2021. The company anticipates receiving CE Mark approval in Europe for LungFit® PH within the first half of 2022. Beyond Air is committed to advancing its nitric oxide delivery system for treating serious respiratory conditions and solid tumors, showcasing its dedication to regulatory collaboration and innovation in pediatric care.
Beyond Air (NASDAQ: XAIR) has appointed Dr. Andrew Colin as Chief Medical Officer effective December 1, 2021. Dr. Colin, with four decades in pediatric pulmonology, has been a key member of Beyond Air’s Scientific Advisory Board since 2013. His extensive experience includes over 20 clinical trials and contributions to various pulmonology advancements. The company is focused on developing inhaled nitric oxide therapies for respiratory conditions and solid tumors. The leadership change is expected to enhance the growth of clinical programs, particularly in acute viral infections and nontuberculous mycobacteria.
Beyond Air has secured $30 million in a private placement of common shares for its affiliate, Beyond Cancer, giving investors a 20% equity stake. This funding will be utilized to accelerate preclinical studies, hire additional team members, and optimize the delivery system for nitric oxide treatments. Beyond Air retains 80% equity ownership in Beyond Cancer. The transaction, expected to close this quarter, aligns with Beyond Air's goal to develop inhaled nitric oxide therapies for pulmonary and cancer-related conditions. The shares are being offered under exemption from registration requirements.
Beyond Air (NASDAQ: XAIR) announced that the U.S. FDA is reviewing its premarket approval submission for LungFit® PH to treat persistent pulmonary hypertension in newborns, aiming for a commercial launch in Q4 2021. The company raised $23.9 million to establish Beyond Cancer, an entity targeting ultra-high concentration nitric oxide for solid tumors. Positive interim results from the LungFit® GO pilot study for NTM lung infections were reported, with full data expected in 2022. Financially, the company reported zero revenue in Q1 2021, with a net loss of $8.7 million.
Beyond Air announces a $23.9 million equity private placement to establish Beyond Cancer, a new entity to advance its solid tumor pipeline with a focus on ultra-high concentration nitric oxide (UNO).
Led by Selena Chaisson, M.D., Beyond Cancer aims to leverage Beyond Air's expertise and intellectual property to develop new oncology treatments. Beyond Air will maintain 80% ownership and receive royalties on future revenues, allowing it to concentrate on its LungFit platform for respiratory diseases.
Beyond Air, Inc. (NASDAQ: XAIR) announced participation in the Piper Sandler 33rd Annual Virtual Healthcare Conference from November 30 to December 2, 2021. CEO Steve Lisi will provide a pre-recorded investor presentation and engage in virtual one-on-one meetings. The presentation will be accessible to registered attendees from November 22 to December 2, 2021. Beyond Air focuses on developing inhaled nitric oxide for respiratory conditions and solid tumors, utilizing its innovative LungFit® system.
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