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]

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]

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]

Core Insights - Beyond Air, Inc. has established Vanderbilt University Medical Center (VUMC) as its first luminary site to evaluate and promote the clinical and operational benefits of its LungFit® PH device, which utilizes tankless nitric oxide (iNO) technology [1][3] - The collaboration aims to enhance hospital-based nitric oxide therapy and optimize LungFit products through VUMC's advanced research and clinical excellence [2] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on using nitric oxide to improve patient outcomes in respiratory illnesses, neurological disorders, and solid tumors [5] - The company has received FDA approval and CE Mark for its LungFit PH system, which is designed for treating term and near-term neonates with hypoxic respiratory failure [5] Product Details - LungFit PH generates nitric oxide from room air, eliminating the need for traditional high-pressure cylinders, thus streamlining operations and enhancing efficiency in hospital settings [3][7] - The device can deliver nitric oxide at concentrations ranging from 1 ppm to 80 ppm, with potential applications in treating severe acute lung infections and chronic lung infections [7][8] Strategic Importance - The partnership with VUMC is seen as a significant step for Beyond Air, allowing the company to demonstrate the full utility of its technology to healthcare professionals and potential customers [3] - VUMC's commitment to medical innovation positions it as an ideal partner for Beyond Air in advancing iNO technology and delivery systems [3]