Beyond Air, Inc. (XAIR) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of a loss of $0.14. This compares to loss of $0.36 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 35.71%. A quarter ago, it was expected that this company would post a loss of $0.18 per share when it actually produced a loss of $0.15, delivering a surprise of 16.67%.Over the last four quarters, the company has surpass ...

Beyond Air (XAIR) Q4 2025 Earnings Call June 17, 2025 04:30 PM ET Company Participants Corey Davis - Investor Relations, LifeSci AdvisorsSteve Lisi - Chairman and CEODouglas Larson - Chief Financial OfficerMarie Thibault - Managing DirectorJoseph Downing - AVP - Equity Research Conference Call Participants Jason Wittes - Managing Director & Senior Research AnalystJustin Walsh - Director & Research AnalystYale Jen - Senior Managing Director & Senior Biotech Analyst Operator Good afternoon, and welcome, every ...

Financial Data and Key Metrics Changes - For the fiscal year ended 03/31/2025, the company reported a 220% increase in revenue to $3.7 million compared to $1.2 million for the same period last year [5][19] - The company anticipates revenue of at least $1.7 million for the quarter ending 06/30/2025, representing greater than 45% sequential quarterly growth and greater than 145% year-over-year growth [6] - Revenue guidance for the full fiscal year ending 03/31/2026 is projected to be between $12 million and $16 million [6][21] - The net loss attributed to common stockholders was $46.6 million, or a loss of $0.69 per share, compared to a net loss of $60.2 million, or a loss of $1.82 per share, for the previous fiscal year [21] Business Line Data and Key Metrics Changes - The commercial team secured three new hospital contracts and renewed three contracts during the fourth quarter [7] - The company has established a solid customer base across key target regions in the U.S. [7] - The company has shipped more than a dozen units of LungFit PH to customers outside the U.S. recently, with expectations for meaningful contributions to financial results starting in the back half of fiscal 2026 [12] Market Data and Key Metrics Changes - The company has ramped up its commercial program across Europe, Southeast Asia, and the Middle East, securing key regulatory approvals and signing distribution agreements covering over 2 billion lives [11] - The company has signed several new international distribution partnerships in countries including India, Italy, and Ukraine [11] Company Strategy and Development Direction - The company aims to make LungFit PH the market leader in the nitric oxide market by overcoming barriers to entry and enhancing customer confidence through increased usage [6] - The company is focused on reducing operating expenses and cash burn while preparing for the launch of its next-generation LungFit PH2 system [22] - The collaboration with Vanderbilt University Medical Center is intended to optimize LungFit products and enhance hospital-based nitric oxide therapy [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue targets and highlighted the potential for significant growth driven by new contracts and international expansion [6][66] - The company is optimistic about the upcoming FDA approval of LungFit PH2, which is expected to have a major impact on market share and logistics within hospitals [10] - Management noted that geopolitical factors have not significantly impacted operations, as most manufacturing occurs in the U.S. [51] Other Important Information - The company has received orphan drug designation for its lead investigational therapy BA102, which is being developed for the treatment of Phelan McDermott syndrome [13] - The company completed a $2 million equity financing to accelerate the preclinical development of its small molecule drug for autism [15] Q&A Session Summary Question: Is the approval of LungFit 2.0 included in the fiscal year 2026 guidance? - Management confirmed that the fiscal year 2026 guidance does not include the second-generation system [28] Question: What are the dynamics of international contracts and usage compared to U.S. hospitals? - Management indicated that initial shipments are for demonstration purposes, and the tender process outside the U.S. takes longer [30] Question: What is the expected timeline for FDA approval of LungFit PH2? - Management refrained from providing a specific timeline but noted that the FDA's average review time is around 180 days [78] Question: How does the company view the competitive landscape following a peer's new offering? - Management stated that they have not seen significant changes in contract negotiations due to the new offering from a competitor [84]

Beyond Air, Inc. XAIR released its fourth-quarter results after Tuesday's closing bell. Here's a look at the key figures from the quarter. The Details: Beyond Air reported quarterly losses of nine cents per share, which beat the analyst consensus estimate of a loss of 12 cents.Quarterly revenue came in at $1.15 million, which missed the Street estimate of $1.39 million and is up from revenue of  $470,000 from the same period last year.Read Next: Sunrun, First Solar Plunge—Solar Stocks Hit Hard By Trump Tax ...

Revenues increased 220% to $3.7 million, compared with $1.2 million for the fiscal year ended March 31, 2024 Expect to report revenue of at least $1.7 million for quarter ending June 30, 2025, and introducing revenue guidance of $12-$16 million for the full fiscal year 2026 Submitted PMA supplement for second-generation LungFit® PH to FDA International distribution partnerships now provide access to markets representing over 2 billion lives, with LungFit® PH actively shipping to Europe, Australia, and the ...

GARDEN CITY, N.Y., May 20, 2025 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company"), a commercial-stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, today announced that it will report financial results for its fiscal fourth quarter and full year ended March 31, 2025 on Tuesday, June 17, 2025. The Company's management team is scheduled to host a conference call and webcast at 4:30 pm Easter ...

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]

The FDA designation marks a significant milestone in the development of a novel treatment for a rare neurodevelopmental disorder Plan to initiate first-in-human U.S. clinical trials of lead drug candidate for treating ASD in 2026 BOSTON, April 21, 2025 (GLOBE NEWSWIRE) -- NeuroNOS, a biopharmaceutical company focused on developing treatments for autism and Alzheimer disorders, and a subsidiary of Beyond Air (NASDAQ: XAIR), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan D ...

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]

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]