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 ...

Financial Data and Key Metrics Changes - Revenue for the fiscal second quarter increased by 128% year-over-year, reaching $1.8 million, up from $0.8 million in the same period last year [4][15] - The company reported a gross loss of $0.3 million for the fiscal second quarter, an improvement from a loss of $1.1 million for the same period last year [16] - Net loss attributed to common stockholders was $7.9 million, or a loss of $1.25 per share, compared to a net loss of $13.4 million, or a loss of $5.67 per share, for the same quarter last year [18] Business Line Data and Key Metrics Changes - The company introduced a capital purchase sales model in the U.S. and had its first hospital purchase of LungFit PH [6] - The sales pipeline remains robust, with substantial opportunities across the U.S. as awareness of LungFit PH builds [4] Market Data and Key Metrics Changes - The company added new distribution partnerships in Japan, South Korea, Mexico, Costa Rica, Guatemala, Panama, and El Salvador, expanding its international coverage to 35 countries [10][11] - The company anticipates reaching its goal of 60 countries under partnership by calendar 2026 [11] Company Strategy and Development Direction - The company is preparing for the launch of its second-generation LungFit system, expected in late calendar 2026, pending FDA approval [8] - A national group purchasing agreement for therapeutic gases with Premier has been awarded, providing access to nearly 3,000 hospitals [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trajectory of growth post-launch of the second-generation LungFit PH, anticipating a steeper growth curve [23] - The company is navigating complexities in hospital sales cycles, with expectations for sequential growth to resume in upcoming quarters [4] Other Important Information - The company raised $12 million in debt and plans to file a registration statement for an additional $20 million through an equity line of credit [5] - The company reported a 37% reduction in total operating expenses year-over-year, down to just above $7.4 million from $11.7 million [16] Q&A Session Summary Question: Expected growth drivers leading into the potential approval of the second-generation LungFit PH - Management believes the trajectory post-launch will be significantly steeper, with international expansion and the introduction of a capital purchase model as key growth drivers [23][24] Question: Comments on timing for commercialization of the second-gen LungFit PH - Management indicated that FDA timing is not the limiting factor, but supply chain issues are affecting the timeline [26] Question: Comparison between the new model and prior ones - The second-generation machine will be about 60% the size of the original, with improved user interface and longer maintenance intervals [28][29] Question: Insights on international deals and pricing models - The international model involves selling to distributors who then use various models, including capital equipment purchases and disposables [33] Question: Update on the updated guidance of $8 million-$10 million - Management noted that the transition in leadership may cause some disruption, but the revenue target is achievable based on current performance [35][36]

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]

Core Insights - Beyond Air has expanded its LungFit PH distribution network to 34 countries, covering a combined population of 2.7 billion people [1][3] - The company has signed new distribution agreements in Japan, South Korea, Costa Rica, Guatemala, Panama, and El Salvador [1][2] - The LungFit PH device generates nitric oxide from ambient air, eliminating the need for traditional high-pressure cylinders, thus streamlining hospital operations and reducing environmental impact [3][5] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on utilizing nitric oxide to improve patient outcomes [10][11] - The LungFit PH system is FDA-approved and designed for treating hypoxic respiratory failure in neonates, with potential applications for severe lung infections [11][12] - The company is advancing other LungFit systems in clinical trials for various respiratory and neurological conditions [11][12] Product Details - LungFit PH is a cylinder-free, phasic flow generator that can deliver nitric oxide at concentrations ranging from 1 ppm to 80 ppm [5][6] - The device is compatible with ventilators and aims to replace large, high-pressure nitric oxide cylinders, providing operational benefits in hospital settings [5][6] - Beyond Air intends to offer nitric oxide treatment in home settings, enhancing accessibility for patients [6][7] Market Position - The company is well-positioned to capture opportunities in both developed and emerging healthcare markets, with hospital tender submissions already underway [3][11] - Beyond Air's distribution agreements are expected to drive significant adoption of its products in the coming years [3][11]

Financial Data and Key Metrics Changes - Revenue for the fiscal quarter ended 06/30/2025 increased by 157% to $1,800,000 compared to $700,000 for the same period last year [5][15] - Gross profit increased to $200,000 from a loss of $300,000 for the same period last year, reflecting the increase in revenues [15] - Net loss attributed to common stockholders was $7,700,000 or a loss of $1.53 per share, compared to a net loss of $12,200,000 or a loss of $5.32 per share for the same period last year [19] Business Line Data and Key Metrics Changes - The company reported a 50% sequential increase in revenue over the quarter ended 03/31/2025 [5] - More than 55% of contracts are multi-year contracts, indicating a stable revenue stream [8] - The first quarter of international revenues was recorded, expanding the company's reach to over 30 countries and covering more than 2 billion lives [8][9] Market Data and Key Metrics Changes - The company has been added to the Premier Network, providing access to nearly 3,000 hospitals [10] - The company anticipates growth in international markets, with expectations of significant revenue contributions in fiscal year 2027 [10][66] Company Strategy and Development Direction - The company is focused on overcoming barriers to entry in the nitric oxide market with the LungFit PH system and plans to introduce LungFit PH2 in calendar year 2026, pending regulatory clearance [6][14] - The company is assessing the best path forward for its Beyond Cancer program and expects to communicate more details once a clinical trial site is secured [12] - The company aims to maintain a strong focus on cost reduction in SG&A, R&D, and supply chain management [16] Management's Comments on Operating Environment and Future Outlook - Management reaffirmed revenue guidance of $12,000,000 to $16,000,000 for fiscal year 2026, indicating confidence in achieving this target [7] - Management noted that while the Premier agreement will not have a major impact this fiscal year, it is expected to significantly contribute in the following fiscal year [26] - The company is optimistic about the growth potential in both domestic and international markets, with ongoing training and support for distribution partners [66] Other Important Information - The company reported a net cash burn of $4,700,000, which is more than 60% lower than the first quarter of the previous fiscal year [20] - As of 06/30/2025, the company had cash, cash equivalents, and marketable securities of $6,500,000, which is expected to support operations into calendar year 2026 [21] Q&A Session Summary Question: How should we think about the various growth drivers coming together this year? - Management indicated that while they are confident in their guidance, they need to see more growth opportunities materialize throughout the fiscal year [25][28] Question: Are there certain countries we should be listening for in terms of international growth? - Management noted that initial sales to distribution partners are for demonstration and training purposes, with hospital wins expected towards the end of the fiscal year [30][32] Question: How long does it take to go from initial contact with a customer to closing a deal? - Management stated that it typically takes anywhere from four to twelve months to close deals, depending on the hospital system [36][38] Question: How should expenses be modeled in relation to revenue growth? - Management explained that expenses will increase in proportion to revenue growth, with some fluctuations expected in the upcoming quarters [41][42] Question: How is the Premier agreement facilitating engagement efforts? - Management confirmed that being part of the Premier network removes significant barriers, allowing for more effective discussions with hospitals [46][48] Question: Can you provide insights on sales so far this quarter? - Management refrained from commenting on quarterly estimates but reiterated confidence in their fiscal year guidance [52][53] Question: What is the current expectation for PMA filings? - Management emphasized that their focus is on the second-generation machine, which is deemed more important than the cardiac indication at this time [56][58]

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]

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]