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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 focused on nitric oxide (NO) solutions, has announced its upcoming fiscal third quarter 2025 financial results conference call. The company will release its financial results for the period ended December 31, 2024, on Monday, February 10, 2025, after market close.
The conference call will be held at 4:30 PM ET on the same day, with domestic and international dial-in numbers available. A webcast of the conference call will be accessible through the Events section of the company's website, with a replay available online after the call.
Beyond Air (NASDAQ: XAIR) has received market authorization from Australia's Therapeutic Goods Administration (TGA) for its LungFit® PH as a Class IIb medical device. The device generates nitric oxide (NO) from room air for delivery into ventilator breathing circuits at user-set concentrations.
The company plans to initiate shipments to Australia through its Asian Pacific partner, Getz Healthcare, in the coming months. This approval follows the recent CE Mark authorization in the European Union, with additional market approvals expected throughout 2025.
LungFit PH uses patented Ionizer® technology to generate unlimited on-demand NO from ambient air, delivering doses ranging from 0.5 ppm to 80 ppm. The system features a Smart Filter that lasts 12 hours and removes toxic nitrogen dioxide byproducts. Operating with the power equivalent of a 60-watt light bulb, the device eliminates the need for tanks or chemicals, supporting hospital sustainability initiatives by reducing carbon footprint.
Beyond Air (NASDAQ: XAIR), a commercial stage medical device and biopharmaceutical company, announced that its Chairman and CEO, Steve Lisi, will participate in the Lytham Partners 2025 Investor Healthcare Summit. The event will occur virtually on Monday, January 13, 2025.
Lisi will engage in one-on-one meetings and deliver a presentation scheduled for 10:30 a.m. ET on the same day. The presentation will be webcast live and can be accessed via the conference home page or directly through the provided link. A replay will also be available through the same links. Investors interested in arranging one-on-one meetings can do so by contacting Lytham Partners at 1x1@lythampartners.com.
Beyond Cancer has received approval from the Israeli Ministry of Health to conduct a Phase 1b clinical trial evaluating Low Volume Ultra-High Concentration Nitric Oxide (LV UNO) in combination with anti-PD-1 therapy. The trial will enroll up to 20 patients with unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic solid tumors who have progressed or shown prolonged stable disease on PD-1 inhibitors.
The study will be conducted at four Israeli sites starting Q1 2025, with topline data expected in H2 2025. The primary objective is to assess preliminary efficacy through objective response rate and duration of response. Preclinical studies showed that a single UNO dose increased PD-L1 expression and improved overall survival compared to anti-PD-1 alone.
Beyond Air (NASDAQ: XAIR) has received European CE mark approval for its LungFit® PH system, a nitric oxide generator for treating newborn infants with hypoxic respiratory failure and peri- and post-operative pulmonary hypertension. This approval enables marketing in the EU and other regions recognizing CE certification. The approval triggers a $1 million milestone payment from Asia-Pacific partner Getz Healthcare, with whom Beyond Air has a commercialization agreement covering multiple Asian markets. The LungFit PH system generates nitric oxide from ambient air using Ionizer® technology, eliminating the need for tanks or chemicals, and operates with minimal power consumption equivalent to a 60-watt light bulb.
NeuroNOS, a subsidiary of Beyond Air (NASDAQ: XAIR), has appointed Nobel Laureate Roger D. Kornberg to its Scientific Advisory Board. Kornberg, who won the 2006 Nobel Prize in Chemistry for his work in molecular biology, will help accelerate the development of treatments for Autism Spectrum Disorder (ASD) and other neurological disorders. As a Stanford University professor and expert in eukaryotic gene transcription, Kornberg will provide insights into molecular mechanisms underlying these disorders and assist in identifying novel therapeutic targets.
Beyond Air (NASDAQ: XAIR), a commercial stage medical device and biopharmaceutical company specializing in Nitric Oxide (NO) treatments, has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The event will take place from December 3-5, 2024, in New York. Steve Lisi, the company's Chairman and CEO, will engage in one-on-one meetings and lead a fireside chat scheduled for Wednesday, December 4, 2024, at 4:30 pm ET.
Beyond Air (NASDAQ: XAIR) reported fiscal Q2 2025 results with revenues of $0.8 million, up 17% from the previous quarter. The company strengthened its balance sheet through a $20.6 million private placement and restructured its debt, retiring $17.5 million from Avenue Capital while securing an $11.5 million loan agreement. Commercial progress includes a 60% increase in hospital contracts and $3.5 million in annualized contracted revenue as of October 1, 2024. The company's cash position of $28.4 million, combined with expected revenue growth, is projected to provide runway through June 2026.
Beyond Cancer presented promising preclinical data on Low Volume Ultra-High Concentration Nitric Oxide (LV UNO) therapy at SITC 2024. The study showed that LV UNO combined with anti-rPD-L1 doubled tumor growth inhibition and improved survival in MAT B III tumor-bearing rats compared to anti-rPD-L1 alone. Additionally, LV UNO proved more effective than High Volume UNO in reducing tumor volumes in CT26 BALB/c mice when combined with anti-mPD-1 treatment. The research demonstrated enhanced nitro-tyrosine staining with LV UNO, indicating better tumor distribution of nitric oxide and potential improved safety outcomes.
Beyond Air (NASDAQ: XAIR), a commercial stage medical device and biopharmaceutical company focused on nitric oxide (NO) treatments, has scheduled its fiscal Q2 2025 financial results conference call for November 11, 2024, after market close. The earnings call will be held at 4:30 PM ET, accessible via phone (domestic: 1-877-407-0784; international: 1-201-689-8560) and webcast through the company's website. A replay will be available online after the call.
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