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 the appointment of Douglas Larson as Chief Financial Officer, effective September 1, 2021, succeeding Douglas Beck, who will act as a consultant post-transition.
Larson brings over 20 years of international finance experience, previously serving at DBV Technologies and The Scotts Miracle-Gro Company. The company granted Larson an inducement stock option for 75,000 shares, exercisable at the last sale price on September 1, 2021. This strategic leadership change is positioned to guide Beyond Air as it transitions towards commercialization.
Beyond Air, Inc. (NASDAQ: XAIR) announced key updates, including ongoing FDA review for the LungFit® PH system to treat persistent pulmonary hypertension of the newborn (PPHN), with commercial launch expected in Q4 2021. Financial results for Q1 2021 showed revenue of $0, dropping from $229,000 in Q1 2020. R&D expenses decreased to $2.7 million, while general and administrative expenses rose to $3.9 million. The net loss for the quarter remained stable at $6.7 million but improved per share to ($0.31). The company holds $39.6 million in cash as of June 30, 2021, indicating a solid financial position.
Beyond Air (NASDAQ: XAIR) will report its financial results for the first fiscal quarter ended June 30, 2021, on August 10, 2021, during a conference call at 4:30 PM ET. The company focuses on developing inhaled nitric oxide treatments for respiratory conditions and solid tumors. Their innovative LungFit® system delivers precise doses of nitric oxide generated from ambient air. Upcoming financial disclosures will provide insights into the company's progress in clinical trials aimed at addressing serious lung infections and other pulmonary diseases.
Beyond Air, Inc. (NASDAQ: XAIR) is a clinical-stage company focusing on inhaled nitric oxide therapies for respiratory conditions. CEO Steve Lisi will attend two virtual investor conferences in July 2021: the Ladenburg Thalmann Annual Healthcare Conference from July 13-14 and the William Blair Biotech Focus Conference from July 14-15. Management will engage in a fireside chat and available for one-on-one meetings during these events. The company is advancing its LungFit® system for treating severe respiratory infections and solid tumors.
Beyond Air submitted its first PMA application to the FDA for LungFit® PH to treat persistent pulmonary hypertension of the newborn, aiming for a commercial launch in Q4 2021. The company appointed industry veterans to its commercial team and presented positive data for high-concentration nitric oxide in patients with viral lung infections. Financially, it reported $873K in revenue for FY 2021, down from $1.4M in FY 2020, with a net loss of $22.9M or ($1.27) per share. Upcoming milestones include expected FDA approval for LungFit® PH by late Q3 2021.
Beyond Air (NASDAQ: XAIR) has secured full global rights to LungFit® PH after reaching an agreement with Circassia Group. The deal involves repaying $10.5 million in upfront payments over two years, post-FDA approval, with future royalties capped at $6 million. LungFit® PH aims to be the first product using ambient air to generate nitric oxide for treating pulmonary conditions. The company anticipates a US launch later this year, with CE Mark expected in the EU. As of April 30, 2021, Beyond Air reported $34.9 million in cash and a quarterly spend of $5 million.
Beyond Air, Inc. (NASDAQ: XAIR) has announced its upcoming financial results for the fourth fiscal quarter and the year ending March 31, 2021, set to be reported on June 10, 2021. A conference call will follow at 4:30 PM ET, allowing the management to discuss outcomes and expectations regarding their innovative LungFit® device, designed for the delivery of nitric oxide to treat various respiratory conditions and solid tumors. The company is advancing its clinical trials targeting severe lung infections and pulmonary hypertension.
Beyond Air announced the appointments of Rebecca Van Doren as Head of Sales and Kori-Ann Taylor as Head of Marketing, both bringing decades of experience in the nitric oxide market.
These strategic hires aim to bolster the LungFit® PH launch in the US. Van Doren has over 20 years of experience, previously leading nitric oxide commercialization at Ikaria and Mallinckrodt, while Taylor has a robust marketing background in healthcare. Their expertise is expected to enhance sales and marketing strategies, positioning Beyond Air favorably in the competitive respiratory market as they prepare for the upcoming launch.
Beyond Air, Inc. (NASDAQ: XAIR) reported positive interim results from its ongoing pilot study using 150 ppm nitric oxide (NO) via LungFit® PRO for treating acute viral pneumonia, including COVID-19. The study showed that NO treatment was well-tolerated, with no treatment-related adverse events identified. In addition, data from three bronchiolitis pilot trials indicated a favorable safety profile and consistent efficacy. The firm is preparing for a pivotal study based on these encouraging signals supporting further development of LungFit® PRO in hospitalized patients with viral pneumonia.
Peter Senior Appointed Director of Business Development at Beyond Air
Beyond Air, Inc. (NASDAQ: XAIR) has announced the appointment of Peter Senior as Director of Business Development. Senior, with 26 years of experience at Linde plc, brings extensive knowledge in the global gas business, particularly in nitric oxide. His leadership is expected to enhance the development of the LungFit® product line, which focuses on treating respiratory conditions and solid tumors. The company aims to secure international partnerships to further advance its innovative therapeutic technologies.
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