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 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.
Beyond Cancer, , a clinical stage biotechnology company, has been selected to present two poster presentations at the upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting 2024. The event is scheduled for November 6-10 at the George R. Brown Convention Center in Houston, Texas. The company will showcase preclinical data on their ultra-high concentration nitric oxide (UNO) Low Volume Therapy.
The presentations will focus on the intratumoral administration of low volume high-concentration nitric oxide in combination with immune checkpoint inhibitors in different tumor models. The studies demonstrated therapeutic efficacy in both mice and rat tumor models. Abstracts will be released to SITC registrants on November 5, 2024, at 9:00 AM U.S. ET, while the full poster presentations will take place on November 8th and 9th. ePublications of the posters will be available on the company's website on November 7th.
Beyond Air (NASDAQ: XAIR) has announced a strategic partnership with Healthcare Links to expand access to its LungFit® PH system through Group Purchasing Organizations (GPOs) and Integrated Delivery Networks (IDNs) across the United States. The LungFit® PH system is a groundbreaking inhaled nitric oxide (NO) generator and delivery system for treating persistent pulmonary hypertension of the newborn (PPHN) and other respiratory conditions.
This partnership aims to streamline the entry of Beyond Air's technology into healthcare systems, leveraging Healthcare Links' expertise in facilitating relationships with GPOs and IDNs. The LungFit® PH system generates NO on-demand from ambient air, eliminating cylinder storage needs and enhancing patient safety and operational efficiency. The collaboration is expected to fast-track the availability of LungFit PH to a larger network of hospitals and healthcare providers, potentially benefiting more patients, particularly vulnerable newborns.
Beyond Air, Inc. (NASDAQ: XAIR) has deployed its LungFit® PH system to the U.S. Naval Hospital Guam for neonatal critical care, in partnership with TrillaMed. The LungFit® PH system generates Nitric Oxide (NO) from room air to treat persistent pulmonary hypertension in neonates (PPHN). Key features include a portable design, advanced NO generating technology, and easy integration into hospital infrastructure.
The U.S. Naval Hospital Guam serves over 17,000 active-duty military personnel and family members, with an expected increase of 2,500 in the next two years. The hospital currently delivers an average of 315 babies per year, projected to rise to 487 births by 2033. This deployment demonstrates the hospital's commitment to utilizing advanced technologies in neonatal care for military families.
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