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]

Core Viewpoint - Beyond Air, Inc. (XAIR) has experienced a downtrend, losing 13.7% over the past week, but a hammer chart pattern suggests a potential trend reversal due to increased buying interest [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottom formation, suggesting that selling pressure may be exhausting and that bulls could be regaining control [2][5]. - The hammer pattern is characterized by a small candle body with a long lower wick, indicating that the stock opened lower, made a new low, but closed near its opening price, reflecting buying interest [4][5]. - This pattern can occur across various timeframes and is utilized by both short-term and long-term investors [5]. Fundamental Analysis - Recent upward revisions in earnings estimates for XAIR serve as a bullish indicator, correlating strongly with near-term stock price movements [7]. - The consensus EPS estimate for the current year has increased by 40.5% over the last 30 days, indicating analysts' optimism about the company's earnings potential [8]. - XAIR holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9][10].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED MARCH 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-38892 BEYOND AIR, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) 900 Stewart Avenue, Suite 301 ...

Fourth Quarter and Full Year 2025 Financial Results and Corporate Update [Overview and Highlights](index=1&type=section&id=Overview%20and%20Highlights) Beyond Air reported significant revenue growth for fiscal year 2025, driven by commercial expansion of its LungFit® PH system and strategic regulatory advancements, with strong revenue guidance for fiscal year 2026 Fiscal Year 2025 and 2026 Revenue Highlights | Metric | Value | Period | | :--- | :--- | :--- | | Revenue | $3.7 million | Fiscal Year 2025 | | Revenue Growth (YoY) | 220% | FY2025 vs FY2024 | | Expected Revenue | At least $1.7 million | Quarter ending June 30, 2025 | | Revenue Guidance | $12 - $16 million | Fiscal Year 2026 | - Submitted a Premarket Approval (PMA) supplement to the FDA for the **second-generation LungFit® PH system**, which is considered potentially transformative for the business[1](index=1&type=chunk)[3](index=3&type=chunk) - International distribution partnerships have expanded access to markets representing **over 2 billion people**, with active shipments to Europe, Australia, and the Middle East[1](index=1&type=chunk)[3](index=3&type=chunk) - Appointed Robert Goodman, a seasoned healthcare executive with a strong commercial background, to the Company's Board of Directors[1](index=1&type=chunk)[5](index=5&type=chunk) [Commercial Execution, Recent Highlights and Upcoming Milestones](index=2&type=section&id=Commercial%20Execution%2C%20Recent%20Highlights%20and%20Upcoming%20Milestones) The company is accelerating commercial adoption of LungFit® PH, expanding its market presence, and advancing key regulatory submissions and pipeline programs including Beyond Cancer and NeuroNOS - LungFit® PH is now installed and in regular use at more than **45 hospitals** nationwide[3](index=3&type=chunk) - Established a partnership with Vanderbilt University Medical Center (VUMC) as the first luminary site for LungFit PH[7](index=7&type=chunk) - Secured new distribution partnerships covering **over 25 countries**, including India, Italy, and several in the Middle East and Eastern Europe[7](index=7&type=chunk) - The FDA review for the cardiac surgery PMA supplement is ongoing; currently, no nitric oxide delivery system is approved for this indication[8](index=8&type=chunk) [Beyond Cancer - Solid Tumor Program](index=3&type=section&id=Beyond%20Cancer%20-%20Solid%20Tumor%20Program) The Beyond Cancer program is advancing clinical trials for its ultra-high concentration Nitric Oxide (UNO) therapy, with ongoing Phase 1a monotherapy and planned Phase 1b combination therapy trials - Phase 1a trial (monotherapy) for UNO therapy in solid tumors has completed the **25,000 ppm** dose cohort and is now evaluating the **50,000 ppm** dose[14](index=14&type=chunk) - Phase 1b trial (combination therapy) will assess UNO therapy in combination with an anti-PD-1 treatment for patients with disease progression[14](index=14&type=chunk) [NeuroNOS – Autism Spectrum Disorder (ASD) Program](index=3&type=section&id=NeuroNOS%20%E2%80%93%20Autism%20Spectrum%20Disorder%20%28ASD%29%20Program) The NeuroNOS program achieved significant milestones, including FDA Orphan Drug Designation for Phelan-McDermid Syndrome, preclinical data publication, and securing **$2 million** in equity financing for its autism drug - The U.S. FDA granted Orphan Drug Designation to BA-102 for the treatment of Phelan-McDermid Syndrome (PMS), a syndrome associated with ASD[14](index=14&type=chunk) - Completed a **$2 million** equity financing in NeuroNOS from private investors to accelerate preclinical development of its small-molecule drug for autism[14](index=14&type=chunk) - Appointed Nobel Prize laureate, Professor Dan Shechtman, to the NeuroNOS Scientific Advisory Board[14](index=14&type=chunk) [Financial Results and Guidance](index=3&type=section&id=Financial%20Results%20and%20Guidance) Beyond Air reported significant revenue growth for fiscal year 2025, alongside a reduced net loss and operating expenses, ending the year with a solid cash position and providing strong fiscal year 2026 revenue guidance Fiscal Year 2025 Financial Performance (Year Ended March 31, 2025) | Metric | FY 2025 (in millions) | FY 2024 (in millions) | YoY Change | | :--- | :--- | :--- | :--- | | Revenues | $3.7 | $1.2 | +220% | | Research and development | $16.9 | $24.4 | -30.7% | | Selling, general and administrative | $26.0 | $37.3 | -30.3% | | Net loss attributable to common stockholders | ($46.6) | ($60.2) | Improvement | | Net loss per share (basic and diluted) | ($0.69) | ($1.82) | Improvement | - As of March 31, 2025, the company had **$6.9 million** in cash, cash equivalents, and marketable securities, with **$12.2 million** in total long-term debt[17](index=17&type=chunk) - Cash burn for fiscal year 2025 was **$44.1 million**, excluding financing impacts[16](index=16&type=chunk) Fiscal Year 2026 Financial Guidance | Metric | Guidance | Period | | :--- | :--- | :--- | | Revenue | At least $1.7 million | Quarter ending June 30, 2025 | | Revenue | $12 - $16 million | Fiscal Year ending March 31, 2026 | [Financial Statements](index=7&type=section&id=Financial%20Statements) The consolidated balance sheet as of March 31, 2025, presents the company's financial position, while the statement of operations details the financial performance for the fiscal year 2025 Consolidated Balance Sheet Highlights (as of March 31, 2025) | Account (in thousands) | March 31, 2025 | March 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $4,665 | $11,378 | | Total current assets | $16,018 | $43,936 | | **Total Assets** | **$30,062** | **$56,961** | | **Liabilities & Equity** | | | | Total current liabilities | $5,000 | $11,567 | | Long-term debt, net | $9,197 | $14,721 | | **Total Liabilities** | **$15,721** | **$29,775** | | **Total Equity** | **$14,341** | **$27,186** | Consolidated Statement of Operations Highlights (For the Year Ended March 31) | Account (in thousands) | 2025 | 2024 | | :--- | :--- | :--- | | Revenues | $3,705 | $1,159 | | Gross loss | ($1,663) | ($1,307) | | Loss from Operations | ($44,537) | ($63,006) | | Net loss | ($48,479) | ($64,295) | | Net loss attributable to Beyond Air, Inc. | ($46,625) | ($60,242) |

Company Overview - Beyond Oil Ltd. is a food-tech innovation company focused on reducing health risks associated with fried food while enhancing sustainability and lowering operational costs [5][7] - The company has developed patented technology that significantly reduces harmful compounds in frying oil, addressing critical health concerns [5][7] Health Risks and Findings - A Medical Opinion by Professor Dr. Ilan Ron highlights the health risks from repeated use of frying oil, including the formation of hazardous chemical byproducts with mutagenic and carcinogenic potential [1][3] - The Medical Opinion establishes a clear association between the consumption of heated oils and increased incidence of various cancers, particularly colorectal, liver, pancreatic, lung, and breast cancers [1][3] - Acrylamide (AA), a hazardous compound formed during frying, is linked to gastrointestinal inflammation, neurotoxicity, and carcinogenesis [2][3] Product Efficacy - Controlled experiments demonstrated that Beyond Oil's product effectively reduces harmful compounds in frying oil, maintaining quality close to fresh oil even after 22 to 51 days of use [3][6] - Key findings from the experiments include low levels of free fatty acids (FFA), significant reduction in carcinogens such as PAHs and AA, and stable oxidation and polymerization indicators [6][7] Recommendations and Implications - The Medical Opinion suggests integrating Beyond Oil's technology as a preventive measure in high-risk settings like schools, hospitals, and industrial kitchens, and promoting public health policies to limit the use of unfiltered reheated oils [4][7] - The endorsement from a leading oncologist underscores the significant health risks associated with reused frying oils and the need for innovative solutions like those offered by Beyond Oil [4][8]

Company Performance - Beyond Air, Inc. reported a quarterly loss of $0.09 per share, better than the Zacks Consensus Estimate of a loss of $0.14, and an improvement from a loss of $0.36 per share a year ago, representing an earnings surprise of 35.71% [1] - The company posted revenues of $1.15 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 17.12%, compared to year-ago revenues of $0.47 million [2] - Over the last four quarters, Beyond Air has surpassed consensus EPS estimates four times but has topped consensus revenue estimates only once [2] Stock Performance - Beyond Air shares have lost approximately 49.9% since the beginning of the year, while the S&P 500 has gained 2.6% [3] - The current consensus EPS estimate for the coming quarter is -$0.12 on revenues of $1.99 million, and for the current fiscal year, it is -$0.42 on revenues of $13.66 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Beyond Air belongs, is currently in the top 35% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, suggesting that industry performance can significantly impact stock performance [5][8]

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]