GARDEN CITY, N.Y., Feb. 20, 2026 (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 commented on the publication of an independent review article providing the most comprehensive overview to date of high‑dose inhaled nitric oxide (iNO) delivered at concentrations well above the FDA‑approved 20 ppm, and presenting mounti ...

Revenue Performance - Revenue increased by 105% year-over-year to $2.2 million for the fiscal quarter ended December 31, 2025, compared to $1.1 million for the same period last year[9] - Total revenues for the three months ended December 31, 2025, were $2,194,000, representing a 104% increase from $1,072,000 in the same period of 2024[34] - The company maintained its fiscal year 2026 revenue guidance of $8-10 million[20] Profit and Loss - Gross profit for the quarter increased to $0.3 million, compared to a gross loss of $0.2 million for the same quarter last year[13] - Gross profit for the three months ended December 31, 2025, was $300,000, compared to a gross loss of $215,000 in the same period of 2024[34] - Net loss attributed to common stockholders was ($7.3) million or a loss of ($0.85) per share, compared to a net loss of ($13.0) million or ($2.96) per share for the same quarter last year[16] - Net loss attributable to Beyond Air, Inc. for the three months ended December 31, 2025, was $7,336,000, compared to a net loss of $13,032,000 in the same period of 2024, indicating a 44% improvement[34] - Comprehensive loss attributable to Beyond Air, Inc. for the three months ended December 31, 2025, was $7,311,000, compared to $13,093,000 in the same period of 2024, reflecting a 44% reduction in losses[34] Expenses - Research and development expenses decreased by 19% to $2.4 million compared to $3.0 million for the same quarter last year[14] - Selling, general and administrative expenses decreased by 42% to $4.5 million from $7.7 million in the same quarter last year[14] - Total operating expenses for the three months ended December 31, 2025, were $6,896,000, down from $10,737,000 in the same period of 2024, reflecting a 36% decrease[34] Cash and Assets - Pro forma cash balance was approximately $22.3 million, including net proceeds of approximately $4.5 million from a recent private placement[5] - Total current assets increased to $25,564,000 as of December 31, 2025, from $16,018,000 as of March 31, 2025, marking a 60% growth[32] - Cash and cash equivalents increased to $6,643,000 as of December 31, 2025, from $4,665,000 as of March 31, 2025, showing a 42% increase[32] Liabilities - Long-term debt increased significantly to $21,974,000 as of December 31, 2025, compared to $9,197,000 as of March 31, 2025, representing a 139% rise[32] - Total liabilities rose to $28,488,000 as of December 31, 2025, from $15,721,000 as of March 31, 2025, reflecting an increase of 81%[32] Business Developments - The company signed a binding letter of intent for XTL Biopharmaceuticals to acquire 85% of Beyond Air's subsidiary NeuroNOS, with potential proceeds of up to $32.5 million[1] - The company completed its first sale of LungFit PH systems to a VA Medical Center, creating a potential pathway for future orders[9] - Phase 1a data from the UNO program in solid tumors is set to be presented at the AACR Annual Meeting in April 2026[4] Share Information - The weighted average number of shares outstanding for the three months ended December 31, 2025, was 8,616,860, compared to 4,403,726 for the same period in 2024, indicating a 96% increase in shares[34]

Product Development and Approval - The LungFit PH system received FDA premarket approval in June 2022 and is indicated for improving oxygenation in neonates with hypoxic respiratory failure associated with pulmonary hypertension [126]. - The company received European CE mark approval for LungFit PH on November 26, 2024, and has since obtained regulatory approvals in over 10 other countries [138]. - The company is developing a proprietary delivery system for ultra-high concentrations of nitric oxide (UNO) for treating solid tumors, currently in phase 1 human clinical trials [128]. - The company has entered into an agreement to acquire commercial rights for nNOS inhibitors targeting autism spectrum disorder (ASD) and other neurological conditions, with development timing under review [130]. Market Potential - The company anticipates U.S. sales potential for LungFit PH to be approximately $350 million and worldwide sales potential to exceed $700 million [139]. - The U.S. market potential for bronchiolitis is estimated to exceed $500 million, while the worldwide market potential is over $1.2 billion [145]. - The U.S. sales potential for Nontuberculous Mycobacteria (NTM) lung infections is projected to be greater than $1 billion, with worldwide sales potential exceeding $2.5 billion [151]. Clinical Trials and Results - The company initiated the first phase of its commercial launch in July 2022 and entered the final phase of the launch process in spring 2023, aiming to become the market leader in the U.S. within a few years [139]. - The pilot clinical trial for the LungFit PRO system showed a trend of shortening length of stay by a factor of 1.8 for patients treated with inhaled NO compared to standard supportive treatment [142]. - The clinical trial for bronchiolitis showed that 150 ppm – 160 ppm NO was safe and effective in shortening hospital length of stay (LOS) and accelerating time to stable oxygen saturation [146]. - The long-term safety data indicated a favorable re-hospitalization rate for bronchiolitis-related reasons in the inhaled NO group compared to control [148]. - Positive interim data from the NTM clinical trial showed high treatment compliance (>90%) and improvement in quality of life and respiratory function [154]. - A case of relapsed/refractory Triple Negative Breast Cancer showed no evidence of malignancy following UNO treatment, indicating potential efficacy [165]. Financial Performance - Revenues for the three months ended December 31, 2025, were $2.2 million, a 104% increase from $1.1 million in the same period of 2024 [173]. - Revenues for the nine months ended December 31, 2025, were $5.8 million, up 126% from $2.6 million in the same period of 2024 [174]. - Gross profit for the three months ended December 31, 2025, was $0.3 million, compared to a gross loss of $0.2 million for the same period in 2024 [173]. - Research and development expenses for the three months ended December 31, 2025, decreased to $2.4 million from $3.0 million in 2024, a reduction of 20% [176]. - Selling, general and administrative expenses for the three months ended December 31, 2025, were $4.5 million, down 43% from $7.7 million in 2024 [178]. - Net loss attributable to common stockholders for the three months ended December 31, 2025, was $7.3 million, or a loss of $0.85 per share, compared to a net loss of $13.0 million, or a loss of $2.96 per share in 2024 [183]. - The company reported a comprehensive loss attributable to Beyond Air, Inc. of $22.8 million for the nine months ended December 31, 2025 [184]. Cash Flow and Funding - Net cash used in operating activities for the nine months ended December 31, 2025, was $13.2 million, primarily due to a net loss of $23.9 million [186]. - For the nine months ended December 31, 2025, net cash used in operating activities was $31.2 million, primarily due to a net loss of $40.4 million [187]. - For the nine months ended December 31, 2025, net cash provided by financing activities was $24.2 million, mainly from the issuance of common stock totaling $8.1 million [190]. - As of December 31, 2025, the company had cash, cash equivalents, and marketable securities of $11.7 million, with an accumulated loss of $309.3 million since inception [192]. - The company expects to incur net losses and cash outflows for at least the next twelve months, indicating a need for additional funding [193]. - On November 1, 2024, the company entered into a Loan and Security Agreement for a secured loan of $11.5 million with a 15% annual interest rate [195]. - On November 4, 2025, the company issued a secured promissory note for $12.0 million, with interest accruing at 15% per annum after the first 12 months [200]. - The company generated revenue of $10.7 million from product sales to date [192]. - The company has experienced a decrease in operating cash flow of $13.2 million for the nine months ended December 31, 2025 [192]. - The company entered into an At-The-Market Offering Sales Agreement allowing for the sale of up to $35.0 million in common stock [197]. - The company is exploring strategic collaborations and licensing agreements to fund operations until sufficient product revenues are generated [205].

Financial Data and Key Metrics Changes - Revenue for the fiscal quarter increased 105% year-over-year to $2.2 million, compared to $1.1 million for the same period last year [6][18] - Gross profit increased to $300,000, compared to a gross loss of $200,000 for the same period last year [19] - Net loss attributed to common stockholders was $7.3 million, or a loss of $0.85 per share, compared to a net loss of $13 million, or a loss of $2.96 per share in the prior year [21] Business Line Data and Key Metrics Changes - The core business, specifically the LungFit PH system, has seen significant adoption with over 45 hospitals now utilizing the first-generation system [6][8] - Customer retention exceeds 90%, with more than half of customers under multi-year agreements [7] Market Data and Key Metrics Changes - The company has expanded its international distribution network to 40 countries, with new agreements in Canada, Germany, Brazil, Austria, the Netherlands, and Sri Lanka [11] - The company is actively engaging with federal healthcare systems, having completed its first sale to a VA Medical Center [10] Company Strategy and Development Direction - The company has made a strategic decision to sell its Neuronas subsidiary, which is expected to provide up to $32.5 million in upfront payments and equity in the acquiring company [5][16] - The focus remains on expanding the utilization of the first-generation LungFit PH system while preparing for the anticipated FDA decision on the second-generation system [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trajectory of the business, citing strong customer feedback and a dedicated team [12] - The company is optimistic about the FDA approval timeline for the second-generation system, with ongoing communication indicating no major hurdles [42] Other Important Information - The company completed a $5 million financing in January 2026, which, along with other funding sources, is expected to support operations into 2027 and potentially profitability [17][23] - Operating expenses were reduced to approximately $6.9 million, down from $10.7 million for the same period last year, reflecting cost reduction initiatives [19][20] Q&A Session Summary Question: How does the company penetrate systems rather than a single hospital at a time? - The product is offered through the ECAT system, which simplifies access for customers and allows competition with other RFPs [28][30] Question: How does the company identify facilities most likely to acquire the system? - The company focuses on refining its commercial organization and utilizing prospecting tools and CRM systems to identify and engage potential customers [31][32] Question: Has there been any change in the length of the sales cycle? - The sales cycle remains around six to nine months, with efforts to identify customers early in their contract processes [33][34] Question: How does the company segment the next-generation system market? - The focus is currently on the first-generation product, with discussions about the next-generation system being more future-oriented [36] Question: What is the status of communications with the FDA regarding the second-generation system? - The company has had constant communication with the FDA and is confident in the timeline for approval [41][42] Question: What recent wins or catalysts are there on the international side? - The company has seen recent wins and is starting to receive reorder requests for filters from customers, indicating product deployment success [47] Question: What attracted XTL Biopharmaceuticals to the Neuronas opportunity? - The science behind the Neuronas opportunity and the clear path to human studies were key factors in attracting XTL [52][54] Question: How did COGS perform in the quarter and what are the expectations for the future? - COGS is expected to be in the 60% range for Gen 1 and move towards 70% for Gen 2 as the company scales [57][58] Question: How sensitive is the sales cycle to increasing SG&A? - Increasing SG&A could potentially translate into more revenues, but the relationship is complex and requires careful management [62]

Financial Data and Key Metrics Changes - Revenue for the fiscal quarter increased 105% year-over-year to $2.2 million, compared to $1.1 million for the same period last year [6][17] - Gross profit increased to $300,000 for the fiscal third quarter 2026, compared to a gross loss of $200,000 for the same period last year [18] - Net loss attributed to common stockholders was $7.3 million, or a loss of $0.85 per share, compared to a net loss of $13 million, or a loss of $2.96 per share in the previous year [20] Business Line Data and Key Metrics Changes - The core business, specifically the LungFit PH system, has seen significant adoption with over 45 hospitals now using the first-generation system [6][7] - Customer retention exceeds 90%, with more than half of customers under multi-year agreements [7] - The company is preparing for the anticipated FDA decision for the second-generation system, expected before the end of calendar 2026 [7] Market Data and Key Metrics Changes - The company has expanded its global distribution network for LungFit PH, now covering 40 countries [10] - Recent sales include the first sale to a VA Medical Center, establishing a foothold in the largest healthcare network in the U.S. [10] - The company has agreements with national group purchasing organizations, providing access to nearly 3,000 hospitals across the U.S. [9] Company Strategy and Development Direction - The company has made a strategic decision to sell its Neuronas subsidiary, which is expected to create long-term value for shareholders [5][15] - The focus remains on expanding the utilization of the first-generation system while preparing for the launch of the second-generation system [7][8] - The second-generation system is designed to offer reduced size and weight, simplified operation, and improved functionality, which is expected to expand the addressable market [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trajectory of the business, citing strong team dedication and positive customer feedback [11] - The company is focused on disciplined execution and delivering advanced nitric oxide solutions to clinicians and patients globally [16] - Management is optimistic about the ongoing communication with the FDA regarding the second-generation system, indicating no major hurdles [40] Other Important Information - The company completed a $5 million financing in January 2026, providing resources to support commercial execution [16] - Cash, cash equivalents, and marketable securities totaled $17.8 million as of December 31, 2025, providing a cash runway into calendar year 2027 [21] Q&A Session Summary Question: Sales process and penetrating healthcare systems - The product is offered through the ECAT system, making it easier for customers to access without going through an RFP process [25][28] Question: Identifying facilities for system acquisition - The company is refining its commercial organization and using prospecting tools to identify and engage potential customers effectively [29][30] Question: Length of the sales cycle - The sales cycle remains around 6-9 months, with efforts to identify customers early in their contract processes [31][32] Question: Concerns about next-generation system affecting current sales - The focus is on the first-generation product while being aware of future conversations regarding the next-generation system [34] Question: FDA communications regarding the second-generation system - The company has had constant communication with the FDA and is confident in the timeline for approval [40] Question: International market wins and catalysts - Recent wins include setting up distributors with demo devices, leading to reorder of filters from hospitals [45] Question: Interest from XTL Biopharmaceuticals in Neuronas - The attractiveness of the Neuronas opportunity lies in the science and clear path to human studies [50][52] Question: COGS performance and future expectations - Long-term COGS is expected to be in the 60% range for Gen 1 and moving towards 70% for Gen 2 [55][56] Question: Impact of increased SG&A on revenues - The relationship between increased SG&A and revenue generation is being evaluated, with no definitive conclusions yet [60]

Financial Data and Key Metrics Changes - Revenue for the fiscal quarter increased 105% year-over-year to $2.2 million, compared to $1.1 million for the same period last year, and a sequential increase of 21% from the previous quarter [15][16] - Gross profit increased to $300,000, compared to a gross loss of $200,000 for the same period last year [16] - Total operating expenses were reduced to approximately $6.9 million, down from $10.7 million for the same period last year, translating to a 36% reduction year-over-year [16][17] - Net loss attributed to common stockholders was $7.3 million, or a loss of $0.85 per share, compared to a net loss of $13 million, or a loss of $2.96 per share for the same period last year [18] Business Line Data and Key Metrics Changes - The core business, particularly the LungFit PH system, has seen significant adoption with over 45 hospitals now utilizing the first-generation system [5][6] - Customer retention exceeds 90%, with more than half of customers under multi-year agreements, indicating strong market acceptance [6] Market Data and Key Metrics Changes - The company has expanded its global distribution network for LungFit PH, now covering 40 countries, with new agreements in Canada, Germany, Brazil, Austria, the Netherlands, and Sri Lanka [9] - The first sale to a VA Medical Center establishes a foothold in the largest healthcare network in the U.S., potentially leading to broader adoption [9] Company Strategy and Development Direction - The company has made a strategic decision to sell its Neuronas subsidiary, which is expected to provide up to $32.5 million in upfront payments and equity, strengthening its balance sheet for commercial execution [5][13] - The focus remains on expanding the utilization of the first-generation LungFit PH system while preparing for the anticipated FDA decision on the second-generation system, expected by the end of calendar 2026 [6][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trajectory of the business, citing strong customer feedback and the dedication of the team as key factors for future growth [10] - The company is optimistic about the upcoming FDA approval process for the second-generation system, with ongoing positive interactions with the FDA [36] Other Important Information - The company completed a $5 million financing in January 2026, along with a $32 million equity line of credit, providing resources to support commercial execution and readiness for the second-generation LungFit PH system [14][19] - The company reported cash and cash equivalents of $17.8 million as of December 31, 2025, which is expected to provide a runway into calendar year 2027 [19] Q&A Session Summary Question: Sales process and penetrating healthcare systems - Management discussed the sales process for the VA system, highlighting the ease of access through the ECAT system, which allows for direct customer engagement without an RFP process [22][24] Question: Identifying target facilities for sales - The company has refined its commercial organization and uses prospecting tools and CRM systems to identify and engage potential customers effectively [26][27] Question: Length of the sales cycle - The sales cycle remains around 6-9 months, with efforts to streamline the process by identifying customer needs early [28][29] Question: Concerns about next-generation system affecting current sales - The focus is on the first-generation product, which is well-received, while discussions about the next-generation system are being kept separate for now [30][31] Question: FDA communications regarding the second-generation system - Management confirmed ongoing positive communications with the FDA and expressed confidence in meeting regulatory requirements [36] Question: International market wins and catalysts - Recent wins in international markets were highlighted, with customers beginning to reorder filters, indicating product stickiness [41] Question: Interest from XTL Biopharmaceuticals in Neuronas - The attractiveness of the Neuronas opportunity was attributed to strong scientific foundations and a clear path to human studies, with XTL providing necessary funding for advancement [48][50] Question: Cost of goods sold (COGS) performance - Long-term expectations for COGS are in the 60-70% range, with current levels expected to grow as revenue increases [53][54] Question: Impact of SG&A on revenue - Management discussed the sensitivity of sales cycles to increased SG&A, indicating that additional capital deployed in sales could translate into higher revenues [58]

Core Insights - Beyond Air, Inc. reported a significant increase in quarterly revenue, achieving $2.2 million for the fiscal quarter ended December 31, 2025, which represents a 105% increase compared to $1.1 million in the same quarter last year [4][12]. - The company maintained its fiscal year 2026 revenue guidance of $8-10 million [19]. - Beyond Air has signed a binding letter of intent for XTL Biopharmaceuticals to acquire 85% of its subsidiary NeuroNOS, with potential proceeds of up to $32.5 million [1]. Financial Performance - The company reported a gross profit of $0.3 million for the quarter ended December 31, 2025, compared to a gross loss of $0.2 million for the same period in 2024 [12]. - Research and development expenses decreased by 19% to $2.4 million, while selling, general, and administrative expenses dropped by 42% to $4.5 million [13]. - The net loss attributed to common stockholders for the quarter was $7.3 million, or a loss of $0.85 per share, compared to a net loss of $13.0 million, or a loss of $2.96 per share, in the same quarter of the previous year [15]. Cash Position and Funding - As of December 31, 2025, Beyond Air had a pro forma cash balance of approximately $22.3 million, which includes cash, cash equivalents, restricted cash, and marketable securities [5][17]. - The company completed a private placement that generated net proceeds of approximately $4.5 million, providing a cash runway into calendar year 2027 [5][17]. Commercial Developments - Beyond Air's LungFit PH system has seen increased demand, with the first sale to a VA Medical Center, indicating potential for broader adoption within the VA system [8]. - The company has expanded its global distribution network for LungFit PH, now covering 40 countries with a combined population of over three billion people [8]. Clinical and Regulatory Updates - Phase 1a data from the UNO program in solid tumors is set to be presented at the AACR Annual Meeting in April 2026 [1][4]. - The company is awaiting FDA clearance for its second-generation LungFit PH system, expected before the end of calendar 2026 [4]. Corporate Governance - Dan Moorhead was appointed as Chief Financial Officer effective January 5, 2026, bringing over 20 years of finance leadership experience [7]. - Bob Carey will assume the role of Chairman of the Board, focusing on strengthening governance and supporting the company's growth [16].

Company Overview - Beyond Cancer, Ltd. is a clinical stage biotechnology company focused on developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, and is a subsidiary of Beyond Air, Inc. [1][3] - The company is conducting a Phase 1 trial of intratumoral UNO in solid tumor metastases, with data to be presented at the AACR Annual Meeting 2026 [1][2]. Research and Development - Beyond Cancer is utilizing a proprietary delivery platform for UNO to treat primary tumors and prevent metastatic disease, with reported anticancer properties and potential as a chemosensitizer and radiotherapy enhancer [3][5]. - The company is also conducting preclinical studies of UNO in multiple solid tumor models to inform additional treatment protocols [3]. Upcoming Events - An abstract featuring data from the Phase 1 trial will be presented by Dr. Amichay Meirovitz at the AACR Annual Meeting 2026, scheduled for April 19, 2026 [2]. - The session will focus on innovative therapeutic modalities and translational platforms, taking place at the San Diego Convention Center [2]. Parent Company Information - Beyond Air, Inc. is a commercial-stage medical device and biopharmaceutical company that leverages nitric oxide to improve patient outcomes in respiratory illnesses, neurological disorders, and solid tumors [4]. - Beyond Air has received FDA approval and CE Mark for its LungFit PH system, which treats hypoxic respiratory failure in neonates [4][6]. Additional Collaborations - Beyond Air has partnered with The Hebrew University of Jerusalem to advance a preclinical program for treating autism spectrum disorder and other neurological disorders [5].

Core Insights - Beyond Air, Inc. is set to report its financial results for the third fiscal quarter ended December 31, 2025, on February 13, 2026 [1] - The management team will host a conference call and webcast at 8:00 AM Eastern Time 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] Research and Development - Beyond Cancer, Ltd., an affiliate of Beyond Air, is exploring ultra-high concentrations of NO with a proprietary delivery system to target specific solid tumors in pre-clinical studies [4]

Summary of Beyond Air (NasdaqCM:XAIR) FY Conference Call Company Overview - **Company**: Beyond Air - **Ticker**: XAIR - **Industry**: Medical Gas (Nitric Oxide) Key Points Product and Technology - **Nitric Oxide (NO)**: A medical gas used primarily as a pulmonary vasodilator to treat conditions like hypoxic respiratory failure in newborns and right ventricular dysfunction post-cardiac surgery [4][5] - **Unique Selling Proposition**: Beyond Air's system generates nitric oxide from room air, eliminating the need for heavy, hazardous cylinders used by competitors, making it more sustainable and cost-effective for hospitals [6][8][10] Market Challenges and Strategy - **Slow Uptake in U.S. Market**: Initial launch difficulties due to the pandemic and compatibility issues with upgraded ventilators delayed market penetration [11][12] - **First-Generation System Limitations**: The first-generation device lacks inter-hospital transport capabilities, which is a drawback in the U.S. market [13] - **Second-Generation Device**: Anticipated FDA approval by the end of 2026, designed to be smaller, user-friendly, and suitable for transport in ambulances and aircraft [14][16] Market Potential - **International Market**: Beyond Air has established distribution partnerships in 40 countries, with expectations of significant revenue growth from international markets over the next 12 to 24 months [18][25] - **Market Size Comparison**: The international market for nitric oxide is projected to be double that of the U.S. market in terms of dollar value over the next five to seven years [21] Clinical Pipeline - **Infectious Diseases**: Ongoing studies on the use of nitric oxide for treating lung infections and COVID-19, with positive results from previous trials [27][29] - **Cancer Treatment**: Research on high-dose nitric oxide for cancer treatment shows promising survival signals in refractory patients [31][34] - **Neurological Conditions**: Preclinical studies on conditions like autism and glioblastoma, with orphan drug status granted by the FDA [35][36] Intellectual Property - **Patent Portfolio**: Strong patent protection for the LungFit machine and related technologies, with patents extending to 2044 [37][39] Financial Position - **Capital Position**: Recent funding has strengthened the balance sheet, providing enough cash to reach the next-generation product approval, with potential needs for additional capital for a proper launch [40][41] Conclusion - Beyond Air is positioned to capture significant market share in the nitric oxide space with its innovative technology and expanding international presence, despite initial challenges in the U.S. market. The company is actively pursuing clinical applications in infectious diseases, cancer, and neurological conditions, supported by a robust patent portfolio and a solid financial foundation.