Product Approvals and Market Potential - LungFit PH received FDA premarket approval in June 2022 for treating hypoxic respiratory failure in neonates, indicated to improve oxygenation and reduce extracorporeal membrane oxygenation needs[36]. - The company received European CE mark approval for LungFit PH on November 26, 2024, allowing treatment of patients on ventilators and those with severe lung infections[37]. - The U.S. sales potential for LungFit PH is estimated at approximately $350 million, with worldwide sales potential exceeding $700 million[49]. - The U.S. market potential for viral pneumonia treatment is greater than $1.5 billion, with worldwide potential exceeding $3 billion[50]. - The company expects to progress the nNOS inhibitors program for autism spectrum disorder to phase 1 clinical trials by the end of 2026[40]. - The U.S. sales potential for NTM treatments is believed to exceed $1 billion, while worldwide sales potential is greater than $2.5 billion[60]. Clinical Trials and Research - The pivotal clinical trial for bronchiolitis showed that 150 ppm NO was effective in shortening hospital length of stay and accelerating time to stable oxygen saturation[56]. - Long-term safety data for high concentration inhaled NO in bronchiolitis indicated a favorable safety profile with no significant difference in re-hospitalization rates compared to control groups[57]. - A clinical trial for LungFitGO began in December 2020, enrolling approximately 20 adult patients, funded by a grant of up to $2.17 million from the Cystic Fibrosis Foundation[61]. - During the clinical trial, a total of 2,492 inhalations were self-administered with overall high treatment compliance (>90%) and no serious adverse events related to treatment discontinuations[63]. - Preclinical data for UNO therapy showed a statistically significant survival benefit in mice treated with UNO plus anti-PD1 compared to anti-PD1 alone[72]. - A Phase 1b trial protocol for UNO + anti-PD-1 combination therapy was approved in December 2024, with enrollment expected to complete by the end of calendar 2025[75]. - The company has conducted clinical trials demonstrating that inhalation of 150-250 ppm NO significantly reduces hospital length of stay by up to 27 hours for bronchiolitis patients[94]. - In a 2017 pilot trial, inhaled NO treatment showed a >40 meters increase in 6MW at day 21 compared to baseline, with a 65% reduction in bacterial load at day 81[99]. - A 2020 clinical trial in Australia received a grant of up to $2.2 million from the CFF, enrolling approximately 20 patients with chronic refractory NTM lung disease[102]. - A 2018 pilot study in bronchiolitis demonstrated a 26.7-hour reduction in hospital length of stay (p=0.04) when comparing inhaled NO to standard of care[108]. - The 2020 bronchiolitis study showed a hazard ratio of 2.01 (p=0.046) for hospital length of stay when comparing 150 ppm NO to standard treatment[110]. Financial Performance and Funding - The Company incurred a net loss of $48.5 million for the year ended March 31, 2025, compared to a net loss of $64.3 million for the year ended March 31, 2024[188]. - As of March 31, 2025, the Company has an accumulated deficit of approximately $286.3 million and anticipates losses declining in fiscal 2026 and 2027[192]. - The Company used approximately $38.2 million in cash for operating activities for the year ended March 31, 2025[192]. - Beyond Cancer raised $30 million in a private placement in Q4 2021, with funding aimed at accelerating preclinical work and clinical trials[66]. - The Company entered into a loan agreement for a secured loan of $11.5 million with an interest rate of 15%, with 3% payable in cash and 12% payable in kind until June 30, 2026[199]. - The Loan Agreement includes covenants that limit the Company's ability to incur additional debt or pay dividends, which could materially affect its business operations[200]. - The Company may need to raise additional capital to meet business requirements, which could dilute current stockholders' ownership interests[193]. Regulatory Compliance and Challenges - The company is subject to FDA regulations, which classify medical devices into three classes based on risk[132]. - The company has a PMA approval pathway that requires extensive data from preclinical studies and human clinical trials[138]. - The FDA imposes stringent regulatory requirements on medical device manufacturers, including compliance with Quality System Regulations (QSR) and maintenance of various documentation files[147]. - Noncompliance with FDA regulations can lead to significant sanctions, including warning letters, fines, and potential criminal prosecution[150]. - The European Economic Area (EEA) requires medical devices to comply with the EU Medical Device Regulation (MDR) to obtain CE marking for marketing[164]. - Compliance with the EU MDR involves a conformity assessment procedure, which may require the intervention of a notified body[164]. - The company is subject to additional federal and state laws and regulations, and non-compliance could adversely affect its financial condition[229]. - The company must comply with HIPAA regulations governing the use and disclosure of protected health information, with potential criminal penalties for violations[233]. Market Competition and Commercialization - The company faces intense competition in the PPHN market, with several competitors developing similar nitric oxide therapies, including Mallinckrodt's INOMAX and Linde Group's NOxBOX[212]. - The company has a limited marketing and sales organization, which may hinder its ability to generate revenue from LungFit PH and other product candidates[216]. - The commercial success of LungFit PH will depend on market acceptance by physicians, patients, and third-party payors, influenced by factors such as safety, efficacy, and cost[218]. - The company anticipates significant pricing pressure due to increased competition and challenges related to third-party coverage and reimbursement practices[221]. - Legislative and regulatory changes in healthcare, such as the ACA, may negatively impact the company's business and results of operations[225]. Intellectual Property and Licensing - The company owns or has exclusively licensed patents related to its NO generator and delivery systems for inhalation[123]. - The company has over 72 pending patent applications worldwide, including U.S., foreign, and PCT applications[126]. - The company has a global, exclusive, transferable license agreement with NitricGen for the eNOGenerator and associated patents[124]. - The company has entered into a settlement agreement with Circassia, agreeing to pay $10.5 million in three installments, with a 5% royalty on LungFit PH net sales starting in 2025, capped at $6 million[130]. Workforce and Corporate Governance - The company has 61 full-time employees globally as of March 31, 2025, with no labor union representation[183]. - The company has established equity and cash incentive plans to attract and retain personnel, aligning their interests with those of stockholders[184]. - The company is currently evaluating options for regaining compliance with Nasdaq listing requirements[181].

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]

Financial Performance - Beyond Air reported quarterly losses of nine cents per share, beating the analyst consensus estimate of a loss of 12 cents [1] - Quarterly revenue was $1.15 million, missing the Street estimate of $1.39 million, but up from $470,000 in the same period last year [1] Business Development - CEO Steve Lisi stated that commercial momentum is building, reflected in topline results, with LungFit PH now installed and in regular use at over 45 hospitals nationwide [2] - There is increasing recognition among clinicians and administrators of the advantages of Beyond Air's cylinder-free system compared to conventional nitric oxide delivery methods [2] Future Outlook - Beyond Air expects first-quarter revenue to be at least $1.7 million and has issued fiscal 2026 revenue guidance in a range of $12 million to $16 million [3] - Following the earnings report, Beyond Air stock was down 9.16% at 26 cents in extended trading after gaining 58.69% in the regular session [3]

Financial Performance - Revenues for the fiscal year ended March 31, 2025, increased by 220% to $3.7 million, compared to $1.2 million for the fiscal year ended March 31, 2024 [7][12] - The company expects to report revenue of at least $1.7 million for the quarter ending June 30, 2025, representing a sequential growth of over 45% [7][24] - Revenue guidance for the full fiscal year 2026 is projected to be between $12 million and $16 million [24] Commercial Developments - The company has established international distribution partnerships that provide access to markets representing over 2 billion lives, with active shipments of LungFit PH to Europe, Australia, and the Middle East [4][7] - LungFit PH is now installed and in regular use at more than 45 hospitals nationwide, increasing awareness among clinicians and administrators [4][7] - A partnership with Vanderbilt University Medical Center has been established as the first luminary site for LungFit PH, marking a significant milestone in the company's mission [7] Regulatory and Product Updates - A PMA supplement for the second-generation LungFit PH has been submitted to the FDA, which could be transformative for the business if approved [4][16] - The company has received FDA approval and CE Mark for its first system, LungFit PH, for treating term and near-term neonates with hypoxic respiratory failure [20] Leadership Changes - Robert Goodman, a seasoned healthcare executive, has been appointed to the company's Board of Directors, effective June 13, 2025 [6][7] Research and Development - Research and development expenses for the fiscal year ended March 31, 2025, were $16.9 million, a decrease from $24.4 million in the previous fiscal year [13] - The company is advancing its other LungFit systems in clinical trials for the treatment of severe lung infections, including viral community-acquired pneumonia and nontuberculous mycobacteria [20][21]

Core Insights - Beyond Air, Inc. 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]

Core Insights - Beyond Air, Inc. is set to report its financial results for the fiscal fourth quarter and full year ending March 31, 2025, on June 17, 2025 [1] - The company specializes in medical devices and biopharmaceuticals, focusing on nitric oxide to treat respiratory illnesses, neurological disorders, and solid tumors [3][4] Financial Reporting - The financial results will be discussed in a conference call and webcast scheduled for June 17, 2025, at 4:30 PM Eastern Time [1][2] - The conference call can be accessed via domestic and international phone lines, with a conference ID provided for participants [2] Company Overview - Beyond Air has received FDA approval and CE Mark for its LungFit® PH system, aimed at treating neonates with hypoxic respiratory failure [3] - The company is advancing other LungFit systems in clinical trials for severe lung infections, including viral community-acquired pneumonia and nontuberculous mycobacteria [3] - A partnership with The Hebrew University of Jerusalem is focused on pre-clinical programs for autism spectrum disorder and other neurological disorders [4] - Beyond Cancer, Ltd., an affiliate of Beyond Air, is exploring ultra-high concentrations of nitric oxide for targeting solid tumors in pre-clinical settings [4]