Beyond Air(XAIR)

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Beyond Air Stock Dips After Mixed Q4 Results: Here's What To Know
Benzinga· 2025-06-17 20:32
Financial Performance - Beyond Air reported quarterly losses of nine cents per share, beating the analyst consensus estimate of a loss of 12 cents [1] - Quarterly revenue was $1.15 million, missing the Street estimate of $1.39 million, but up from $470,000 in the same period last year [1] Business Development - CEO Steve Lisi stated that commercial momentum is building, reflected in topline results, with LungFit PH now installed and in regular use at over 45 hospitals nationwide [2] - There is increasing recognition among clinicians and administrators of the advantages of Beyond Air's cylinder-free system compared to conventional nitric oxide delivery methods [2] Future Outlook - Beyond Air expects first-quarter revenue to be at least $1.7 million and has issued fiscal 2026 revenue guidance in a range of $12 million to $16 million [3] - Following the earnings report, Beyond Air stock was down 9.16% at 26 cents in extended trading after gaining 58.69% in the regular session [3]
Beyond Air® Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-06-17 20:01
Financial Performance - Revenues for the fiscal year ended March 31, 2025, increased by 220% to $3.7 million, compared to $1.2 million for the fiscal year ended March 31, 2024 [7][12] - The company expects to report revenue of at least $1.7 million for the quarter ending June 30, 2025, representing a sequential growth of over 45% [7][24] - Revenue guidance for the full fiscal year 2026 is projected to be between $12 million and $16 million [24] Commercial Developments - The company has established international distribution partnerships that provide access to markets representing over 2 billion lives, with active shipments of LungFit PH to Europe, Australia, and the Middle East [4][7] - LungFit PH is now installed and in regular use at more than 45 hospitals nationwide, increasing awareness among clinicians and administrators [4][7] - A partnership with Vanderbilt University Medical Center has been established as the first luminary site for LungFit PH, marking a significant milestone in the company's mission [7] Regulatory and Product Updates - A PMA supplement for the second-generation LungFit PH has been submitted to the FDA, which could be transformative for the business if approved [4][16] - The company has received FDA approval and CE Mark for its first system, LungFit PH, for treating term and near-term neonates with hypoxic respiratory failure [20] Leadership Changes - Robert Goodman, a seasoned healthcare executive, has been appointed to the company's Board of Directors, effective June 13, 2025 [6][7] Research and Development - Research and development expenses for the fiscal year ended March 31, 2025, were $16.9 million, a decrease from $24.4 million in the previous fiscal year [13] - The company is advancing its other LungFit systems in clinical trials for the treatment of severe lung infections, including viral community-acquired pneumonia and nontuberculous mycobacteria [20][21]
Beyond Air Submits FDA PMA Supplement for Next Generation LungFit® PH
Globenewswire· 2025-06-16 12:00
Core Insights - Beyond Air, Inc. has submitted a premarket approval supplement application to the FDA for its next-generation therapeutic nitric oxide generator, LungFit PH II, which is designed to be smaller, lighter, and fully transport-ready [3][4] - The LungFit PH II system utilizes patented Ionizer™ technology to generate unlimited on-demand nitric oxide from ambient air, ensuring compatibility with existing devices and minimal disruption for current users [5][6] - The new system aims to enhance the delivery of nitric oxide therapy for conditions such as persistent pulmonary hypertension of the newborn (PPHN), which affects approximately 1.9 per 1,000 live births and has a mortality rate ranging from 4% to 33% [11][12] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on utilizing nitric oxide to treat respiratory illnesses, neurological disorders, and solid tumors [12][13] - The company has received FDA approval for its first system, LungFit PH, which is used for treating hypoxic respiratory failure in neonates [12] - Beyond Air is advancing other LungFit systems in clinical trials for severe lung infections, including COVID-19 and nontuberculous mycobacteria [12] Product Features - LungFit PH II is designed to deliver nitric oxide at concentrations ranging from 0.5 ppm to 80 ppm, with a standard delivery of 20 ppm for ventilated patients [6][8] - The system includes a Smart Filter that provides 12 hours of therapy and can be replaced quickly, ensuring uninterrupted treatment [6] - The device operates using the equivalent power of a 60-watt lightbulb, producing low levels of nitrogen dioxide as a byproduct, which is filtered out [5][6] Market Potential - The introduction of LungFit PH II is expected to significantly enhance Beyond Air's market position and expand its reach in hospital-based nitric oxide delivery systems [7] - Nitric oxide therapy has been the standard of care for PPHN in the U.S. for over 20 years, indicating a stable market demand for effective treatment options [11] - Beyond Air aims to replace traditional high-pressure nitric oxide cylinders with its innovative system, which could lead to improved safety and operational efficiencies in hospital settings [8][9]
Beyond Air Schedules Fiscal Year End 2025 Financial Results Conference Call and Webcast
Globenewswire· 2025-05-20 12:00
Core Insights - Beyond Air, Inc. is set to report its financial results for the fiscal fourth quarter and full year ending March 31, 2025, on June 17, 2025 [1] - The company specializes in medical devices and biopharmaceuticals, focusing on nitric oxide to treat respiratory illnesses, neurological disorders, and solid tumors [3][4] Financial Reporting - The financial results will be discussed in a conference call and webcast scheduled for June 17, 2025, at 4:30 PM Eastern Time [1][2] - The conference call can be accessed via domestic and international phone lines, with a conference ID provided for participants [2] Company Overview - Beyond Air has received FDA approval and CE Mark for its LungFit® PH system, aimed at treating neonates with hypoxic respiratory failure [3] - The company is advancing other LungFit systems in clinical trials for severe lung infections, including viral community-acquired pneumonia and nontuberculous mycobacteria [3] - A partnership with The Hebrew University of Jerusalem is focused on pre-clinical programs for autism spectrum disorder and other neurological disorders [4] - Beyond Cancer, Ltd., an affiliate of Beyond Air, is exploring ultra-high concentrations of nitric oxide for targeting solid tumors in pre-clinical settings [4]
Beyond Air Granted U.S. Patent Covering Treatment of NTM Infections Using gaseous Nitric Oxide (gNO)
Globenewswire· 2025-04-24 20:05
Core Insights - Beyond Air, Inc. has received U.S. Patent No. 12,274,830 for its method of delivering gaseous nitric oxide (gNO) to treat non-tuberculous mycobacteria (NTM) lung infections, enhancing its intellectual property portfolio and supporting its LungFit program [1][2] - The patent covers a dosing regimen of 200 ppm to 320 ppm gNO for 10 to 45 minutes, administered 2 to 5 times daily, providing a total NO load of 300 ppm-hrs to 900 ppm-hrs over at least 14 days, with an expiration date of March 12, 2038 [2] - NTM infections are serious and rare, leading to chronic lung disease, with 13% of U.S. cystic fibrosis patients testing positive for NTM in 2017, highlighting the need for effective treatments [3] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on using nitric oxide to treat respiratory illnesses, neurological disorders, and solid tumors, with FDA approval for its LungFit® PH system [4] - The company is advancing other LungFit systems in clinical trials for severe lung infections, including viral pneumonia and NTM [4][5] - Beyond Air has partnered with The Hebrew University of Jerusalem for a pre-clinical program targeting autism spectrum disorder and is exploring ultra-high concentrations of NO for solid tumors [5] Product Details - The LungFit® system is a cylinder-free delivery device that generates NO from ambient air, offering advantages in hospital settings by reducing inventory and improving safety [6][7] - It can deliver NO at concentrations above 80 ppm for treating severe acute lung infections in hospitals and chronic infections at home [7][8] - The LungFit PH system is approved for commercial use in multiple regions, while other systems are still investigational [8]
NeuroNOS Granted FDA Orphan Drug Designation for Phelan-McDermid Syndrome, a Neurodevelopmental Disorder Linked to Autism
Globenewswire· 2025-04-21 20:05
Core Insights - The FDA has granted Orphan Drug Designation (ODD) to NeuroNOS's lead investigational therapy, BA-102, for treating Phelan-McDermid Syndrome (PMS), a condition associated with Autism Spectrum Disorder (ASD) [1][3] - NeuroNOS plans to initiate first-in-human clinical trials for ASD in the U.S. in 2026 [1] Company Overview - NeuroNOS is a biopharmaceutical company focused on developing treatments for autism and Alzheimer disorders, and is a subsidiary of Beyond Air [1][5] - The company specializes in therapies based on small molecules that can cross the blood-brain barrier to regulate Nitric Oxide (NO) levels in the brain [5] Disease Background - Phelan-McDermid Syndrome (PMS) is a rare genetic disorder primarily caused by deletions or mutations affecting the SHANK3 gene, leading to symptoms such as global developmental delay, intellectual disability, and severe speech impairments [2][4] - There are currently no FDA-approved treatments specifically indicated for PMS [2] Development Incentives - The ODD provides several key development incentives, including seven years of market exclusivity upon approval, tax credits for qualified clinical trials, waiver of FDA application fees, and access to FDA protocol assistance [3] Commitment to Development - NeuroNOS is committed to collaborating with the FDA, patient advocacy groups, scientific foundations, and clinical investigators to accelerate the development of therapies for PMS [4]
NeuroNOS Appoints Nobel Prize Laureate, Professor Dan Shechtman, to Scientific Advisory Board
Globenewswire· 2025-04-15 20:05
Core Insights - NeuroNOS has appointed Nobel Prize laureate Professor Dan Shechtman to its Scientific Advisory Board, enhancing its scientific expertise in developing treatments for Autism Spectrum Disorder (ASD) and Alzheimer's Disease (AD) [1][2] - The company utilizes a proprietary platform that integrates advanced behavioral techniques, AI, and wet lab capabilities to accelerate treatment development for complex neurological disorders [2][5] - NeuroNOS is on track to initiate first-in-human clinical trials for ASD in the United States in 2026, marking a significant step in its mission to transform treatment for affected individuals and families [2][4] Company Overview - NeuroNOS is focused on developing innovative therapies for neurodevelopmental and neurodegenerative disorders, particularly through small molecules that regulate Nitric Oxide (NO) levels in the brain [5] - Preclinical studies indicate elevated NO levels in children with ASD and adults with brain-related diseases, suggesting that managing NO levels is crucial for normal brain function [5] - The company collaborates with leading research institutions to advance medical innovation and deliver impactful treatments [5] Scientific Advisory Board - The addition of Professor Shechtman, alongside Professor Roger Kornberg, brings unparalleled scientific expertise to NeuroNOS, significantly enhancing its research capabilities [2][4] - Professor Shechtman is recognized for his groundbreaking discovery of quasicrystals and has decades of experience in materials science and structural chemistry [3] - His involvement is expected to elevate the scientific rigor at NeuroNOS and accelerate the development of effective treatments for ASD [4]
Beyond Air Publishes Article in Annals of the American Thoracic Society Journal Highlighting NTM-PD Patients' Ability to Safely Self-Administer High-Dose Intermittent iNO Treatments Using the LungFit™ GO at Home
GlobeNewswire News Room· 2025-04-09 20:05
Core Insights - Beyond Air, Inc. announced the publication of a scientific article on the use of intermittent inhaled nitric oxide (iNO) for treating nontuberculous mycobacteria (NTM) lung infections, highlighting its potential as a novel anti-NTM agent [1][2][3] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on utilizing nitric oxide (NO) to treat respiratory illnesses, neurological disorders, and solid tumors [7][8] - The company has received FDA approval and CE Mark for its LungFit® PH system, aimed at treating hypoxic respiratory failure in neonates, and is advancing other LungFit systems in clinical trials for severe lung infections [7][11] Clinical Study Details - The LungFit GO NTM Trial was a 12-week, multi-center, open-label clinical trial involving 15 subjects with chronic refractory NTM lung disease, supported by the U.S. Cystic Fibrosis Foundation [3][4] - Subjects were treated with high doses of iNO, starting at 150 ppm and titrated to 250 ppm, with a high treatment compliance rate of over 90% and no serious adverse events reported [4][5] Efficacy and Safety Findings - Key efficacy endpoints showed meaningful improvements in quality of life, particularly in respiratory symptoms and emotional functioning, with trends indicating a reduction in microbial load [5] - The study demonstrated a favorable safety profile, with no occurrences of methemoglobinemia and no treatment-related discontinuations [4][5] Future Directions - The results from the pilot study support the need for further evaluation of iNO as a treatment for NTM infections in larger pivotal studies [2][3]
Beyond Air Publishes Article in Annals of the American Thoracic Society Journal Highlighting NTM-PD Patients' Ability to Safely Self-Administer High-Dose Intermittent iNO Treatments Using the LungFit™ GO at Home
Newsfilter· 2025-04-09 20:05
Core Insights - Beyond Air, Inc. has published a scientific article on the use of intermittent inhaled nitric oxide (iNO) for treating nontuberculous mycobacterial (NTM) lung infections, highlighting its potential as a novel anti-NTM agent [1][2][3] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on utilizing nitric oxide (NO) to treat respiratory illnesses, neurological disorders, and solid tumors [7][8] - The company has received FDA approval and CE Mark for its LungFit® PH system, aimed at treating hypoxic respiratory failure in neonates [7][11] Clinical Study Details - The LungFit GO NTM Trial was a 12-week, multi-center, open-label clinical trial conducted in Australia, involving 15 adult subjects with chronic refractory NTM lung disease [3][4] - The trial demonstrated high compliance (>90%) with the treatment, and no serious adverse events were reported during the 12-week treatment or follow-up periods [4][5] Efficacy and Safety Findings - Key efficacy endpoints showed meaningful improvements in quality of life, particularly in respiratory symptoms and emotional functioning [5] - Trends in the reduction of microbial load were observed, with one subject achieving culture conversion during the follow-up phase [5] Future Directions - The company plans to further evaluate the efficacy of inhaled NO in larger pivotal studies, as the pilot study results support its potential value [2][3]
NeuroNOS Announces Groundbreaking Research Publication by its CSO Demonstrating Mechanism of Action in Alzheimer’s Disease and Reinforcing Platform’s Strength Across Neurological Disorders
Globenewswire· 2025-04-01 12:00
Company Overview - NeuroNOS is a biopharmaceutical company focused on developing treatments for complex neurological disorders, including Autism Spectrum Disorder, brain cancers, and Alzheimer's disease [1][9] - The company is a subsidiary of Beyond Air (NASDAQ: XAIR) and has established a drug development platform aimed at addressing critical gaps in treatment options for neurological conditions [1][10] Recent Research and Developments - NeuroNOS announced the publication of breakthrough research by its Chief Scientific Officer, Prof. Haitham Amal, in the journal Translational Psychiatry, which presents evidence of a novel mechanism in the early stages of Alzheimer's disease [1][3] - The research identifies significant disruptions in nitric oxide (NO)-related pathways and suggests that targeted inhibition of NO production may serve as a promising therapeutic strategy for early-stage Alzheimer's disease [3][4] Market Opportunity - The global brain therapeutics market is substantial and growing, driven by an aging population and increasing prevalence of neurological disorders, with significant unmet medical needs [7] - NeuroNOS's innovative approach positions the company to capitalize on this expanding market by addressing critical treatment gaps for complex brain diseases [7] Strategic Collaborations and Intellectual Property - NeuroNOS has filed five patent families to protect its novel approach and is collaborating with leading international partners for the production of active pharmaceutical ingredients and advanced formulations [4][5] - The company's scientific team includes experts from top hospitals and institutions, including the Hebrew University of Jerusalem, which plays a central role in its research and development efforts [6][10] Clinical Development Plans - NeuroNOS is preparing for clinical trials, with plans to initiate first-in-human trials for autism in the United States in 2026 [4][8] - The company has previously achieved preclinical breakthroughs in autism and glioblastoma models, reinforcing the versatility of its nitric oxide modulation platform [8]