Launched search for permanent successorGARDEN CITY, N.Y., Nov. 26, 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 Doug Larson has resigned as Chief Financial Officer to pursue another opportunity. Mr. Larson will continue to serve as CFO through December 5, 2025, at which time the CFO responsibil ...

Core Insights - Beyond Air, Inc. reported a significant revenue increase of 128% year over year, reaching $1.8 million for the fiscal quarter ended September 30, 2025, compared to $0.8 million for the same period last year [5][10] - The company appointed Bob Goodman as Interim Chief Commercial Officer to lead its commercial strategy following the departure of David Webster [3][5] - Beyond Air raised $12 million in debt financing, resulting in a proforma cash balance of $22.9 million as of September 30, 2025, which is expected to support operations into calendar 2027 [9][16] - The company updated its fiscal year 2026 revenue guidance to a range of $8 million to $10 million [17] Financial Performance - Revenue for the fiscal quarter ended September 30, 2025, was $1.8 million, a 128% increase from $0.8 million in the same quarter of 2024 [10] - Gross loss decreased to $0.3 million for the quarter, down from a gross loss of $1.1 million in the prior year, attributed to sales growth and one-time costs [10][15] - Research and development expenses were $2.5 million, down from $4.6 million in the same quarter of 2024, primarily due to reduced salaries and development costs [11] - Selling, general, and administrative expenses decreased to $4.9 million from $7.2 million year-over-year, reflecting cost management efforts [12] Commercial Strategy and Developments - The company is expanding its global distribution network for LungFit PH, now covering 35 countries with a combined population of 2.8 billion [5] - Beyond Air achieved certification for the Medical Device Single Audit Program (MDSAP), enhancing its compliance across multiple international markets [5] - The U.S. Patent and Trademark Office granted a design patent allowance for the second-generation LungFit PH, extending protection through 2040 [5] Regulatory and Clinical Updates - The company is preparing for regulatory approvals outside the U.S. and anticipates FDA approval for its second-generation LungFit PH by the end of calendar 2026 [4] - The PMA supplement for the second-generation LungFit PH was submitted to the U.S. FDA in June 2025 [14] - The company is advancing clinical trials for its investigational therapies, including BA-101 for Glioblastoma and BA-102 for Phelan-McDermid Syndrome, both of which received Orphan Drug Designation from the FDA [14] Upcoming Events - Beyond Air will participate in the AARC Annual Congress from December 6 to 8, 2025, in Phoenix, AZ [5]

Core Viewpoint - Beyond Air, Inc. has secured financing agreements with Streeterville Capital, providing up to $32 million to support its commercial expansion and potential profitability [2][3]. Financing Agreements - The company entered into a $12 million promissory note with a 15% annual interest rate, maturing in 24 months, with no payments due in the first year [3]. - Additionally, a $20 million Equity Line of Credit (ELOC) allows the company to sell newly issued shares over 24 months, with proceeds designated for various corporate purposes [4]. Financial Position - As of September 30, 2025, Beyond Air reported proforma cash and equivalents totaling $22.9 million, which includes the $12 million from the promissory note [1]. Strategic Goals - The financing is aimed at accelerating the commercial expansion of LungFit PH, with expectations of driving sales growth and achieving profitability by the anticipated launch of a second-generation product by the end of 2026 [3]. Company Overview - Beyond Air is focused on developing medical devices and biopharmaceuticals utilizing nitric oxide to treat respiratory illnesses and other conditions [6]. - The company has received FDA approval for its LungFit PH system, which is designed for treating neonates with hypoxic respiratory failure [6][10].

Core Insights - Beyond Air, Inc. will report its financial results for the second fiscal quarter ended September 30, 2025, on November 10, 2025, with a conference call scheduled for 4:30 PM ET on the same day [1] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on utilizing nitric oxide (NO) to enhance the lives of patients with respiratory illnesses, neurological disorders, and solid tumors [3] - The company has received FDA approval and CE Mark for its first system, LungFit PH, aimed at treating term and near-term neonates with hypoxic respiratory failure [3] - Beyond Air is advancing other LungFit systems in clinical trials for severe lung infections, including viral community-acquired pneumonia and nontuberculous mycobacteria [3] Partnerships and Research Initiatives - The company has partnered with The Hebrew University of Jerusalem to develop a pre-clinical program for treating autism spectrum disorder and other neurological disorders [4] - Beyond Cancer, Ltd., an affiliate of Beyond Air, is exploring ultra-high concentrations of NO with a proprietary delivery system targeting specific solid tumors in pre-clinical studies [4]

Financial Performance - Revenues increased by 157% to $1.8 million for the fiscal quarter ended June 30, 2025, compared to $0.7 million for the same period last year [7][10] - Gross profit for the quarter was $0.2 million, a significant improvement from a gross loss of $0.3 million in the prior year [10] - Research and development expenses decreased to $3.1 million from $6.0 million year-over-year, primarily due to reductions in salaries and clinical study costs [11] - Selling, general and administrative expenses also decreased to $4.7 million from $7.2 million, attributed to lower salaries and marketing costs [12] - Net loss attributed to common stockholders was $7.7 million, or a loss of $1.53 per share, compared to a net loss of $12.2 million, or $5.32 per share, in the previous year [14] Business Developments - The company was awarded a national group purchasing agreement for therapeutic gases by Premier, Inc., which includes over 4,350 member hospitals and health systems [7] - Strong sequential revenue growth of approximately 50% was reported, with revenues rising from $1.2 million for the quarter ended March 31, 2025, to $1.8 million [2] - The company reaffirmed its revenue guidance for the full fiscal year 2026, expecting revenues between $12 million and $16 million [16] Product and Market Expansion - The LungFit PH system is driving market adoption and expanding the global distribution network, with recent regulatory approvals facilitating international sales [2][7] - The company has expanded its reach in the U.S. through the new purchasing agreement, allowing Premier members to access special pricing for the LungFit PH system [7] - Beyond Air is advancing its clinical programs, including the development of the second-generation LungFit PH and the Beyond Cancer program targeting solid tumors [4][6] Cash Position and Debt - As of June 30, 2025, the company reported cash, cash equivalents, and marketable securities totaling $6.5 million, with total long-term debt outstanding of $11.6 million [15] - The net cash burn for the quarter was $4.7 million, indicating ongoing investment in growth and development [15]

Core Insights - Beyond Air, Inc. is set to report its financial results for the first fiscal quarter ending June 30, 2025, on August 12, 2025, with a conference call scheduled for 4:30 PM ET [1] - The company focuses on utilizing nitric oxide to enhance the treatment of patients with respiratory illnesses, neurological disorders, and solid tumors [3][4] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company that has received FDA approval and CE Mark for its LungFit® PH system, aimed at treating hypoxic respiratory failure in neonates [3] - The company is advancing other LungFit systems in clinical trials for severe lung infections, including viral community-acquired pneumonia and nontuberculous mycobacteria [3] - Beyond Air has partnered with The Hebrew University of Jerusalem to develop a pre-clinical program for autism spectrum disorder and other neurological disorders [4] - An affiliate, Beyond Cancer, is investigating ultra-high concentrations of nitric oxide for targeting solid tumors in pre-clinical settings [4]

Core Insights - Beyond Air, Inc. has been awarded a national group purchasing agreement for therapeutic gases with Premier, Inc., effective July 15, 2025, allowing Premier members to access special pricing for the LungFit PH system and disposable NO2 Smart Filters [1][2] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on utilizing nitric oxide (NO) to enhance patient care, particularly for respiratory illnesses and neurological disorders [8][10] - The LungFit PH system is designed to deliver nitric oxide on demand from ambient air, providing a cylinder-free solution that improves safety and operational efficiency in healthcare settings [2][5] Product Details - The LungFit PH system can deliver NO doses ranging from 0.5 ppm to 80 ppm, with a standard delivery of 20 ppm for ventilated patients, and each Smart Filter provides 12 hours of therapy [2][5] - The system operates using only the power equivalent to a 60-watt lightbulb, minimizing nitrogen dioxide (NO2) byproduct levels [2][5] - Beyond Air's LungFit PH is approved for commercial use in multiple regions, including the U.S., EU, and Australia, while other LungFit systems are still in investigational stages [7][8] Strategic Partnerships - The agreement with Premier was facilitated by HealthCare Links, a consulting group specializing in national group purchasing organization access [4] - Premier serves a significant portion of U.S. healthcare providers, enhancing the distribution and accessibility of Beyond Air's products [3] Market Potential - The LungFit system has the potential to replace traditional high-pressure NO cylinders, significantly reducing inventory and storage needs in hospitals [5][6] - Beyond Air is also exploring the use of its technology for treating severe lung infections and chronic conditions in both hospital and home settings [6][9]

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 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]