GARDEN CITY, N.Y., July 22, 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, has been awarded a national group purchasing agreement for therapeutic gases with Premier, Inc. Effective July 15th, the new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated b ...

Financial Data and Key Metrics Changes - For the fiscal year ended 03/31/2025, the company reported a 220% increase in revenue to $3,700,000 compared to $1,200,000 for the same period last year [5][19] - The company anticipates revenue of at least $1,700,000 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 $12,000,000 and $16,000,000 [6][21] - The net loss attributed to common stockholders for the fiscal year was $46,600,000, or a loss of $0.69 per share, compared to a net loss of $60,200,000, 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 [8] - The company has established a solid customer base across key target regions in the US, with 45 hospitals either installed or using the LungFit system [68] 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 2,000,000,000 lives [11] - Initial shipments of LungFit PH to international customers have begun, with expectations for meaningful contributions to financial results starting in the latter half of fiscal 2026 [12] Company Strategy and Development Direction - The company aims to make LungFit PH the market leader in the nitric oxide market, overcoming barriers to entry and enhancing customer confidence through increased usage [7] - The introduction of LungFit PH2, a next-generation system, is expected to significantly impact market share and logistics within hospitals [10] - The company is focused on cost reduction efforts, having reduced operating expenses from over $17,000,000 to just above $7,000,000 in the current quarter, translating to a 58% reduction [22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue targets for the upcoming quarter and fiscal year, citing strong customer interest and flexibility in contract structures [66] - The company is optimistic about the potential for international growth, although it acknowledges the longer tender processes outside the US [31][59] Other Important Information - The company received orphan drug designation from the FDA for its lead investigational therapy BA102, which is being developed for the treatment of Phelan McDermott syndrome [13] - The company announced the appointment of Bob Goodman to the board of directors, bringing extensive commercial leadership experience [16] 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 US hospitals? - Management indicated that initial shipments are for demonstration purposes, and the tender process outside the US takes longer [31] Question: What is the expected timeline for FDA approval of LungFit 2.0? - Management refrained from providing a specific timeline, noting the current upheaval at the FDA [40] Question: What factors could lead to achieving the higher end of the revenue guidance range? - Management mentioned that securing large contracts and regulatory approvals could significantly impact revenue [42] Question: How is the company addressing potential geopolitical impacts on supply and sales? - Management stated that the majority of manufacturing is in the US, and geopolitical issues have minimal impact on costs [53] Question: How does LungFit 2.0 expand the market? - Management noted that the new system would allow access to every hospital wanting to use nitric oxide, significantly increasing market reach [82]

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]

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]

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. 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 - 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]