Core Insights - Beyond Cancer, Ltd. has reported early signs of clinical activity and a favorable safety profile for its investigational immunotherapeutic, ultra-high concentration nitric oxide (UNO), in a Phase 1 clinical trial for solid tumors [1][4] Group 1: Clinical Trial Details - The Phase 1 trial (NCT05351502) involved ten heavily pretreated patients with unresectable cutaneous or subcutaneous lesions, including breast cancer (6 patients), squamous cell carcinoma (2 patients), and melanoma (2 patients) [2] - Patients had a mean of 5.5 prior systemic therapies and 10.3 total cancer-directed treatments, with six patients receiving 25,000 ppm UNO and four patients receiving 50,000 ppm UNO [2] Group 2: Patient Outcomes - As of October 1, 2025, seven out of ten patients remained alive between 19 to 37 months post-treatment, with one patient dying from disease progression 25 months after treatment [3] - Two patients with triple-negative breast cancer showed no evidence of disease, and no deaths occurred within 12 weeks after treatment [3] Group 3: Safety and Tolerability - The treatment demonstrated a favorable safety and tolerability profile, with most treatment-related adverse events classified as Grade 1; one serious adverse event (hypoxia) occurred but was not dose-limiting and resolved fully [3] Group 4: Future Directions - The CEO of Beyond Air expressed optimism that UNO could complement anti-PD-1 therapy in metastatic disease and potentially serve as a monotherapy prior to metastases, highlighting the compelling survival duration in this heavily pre-treated population [4] Group 5: Upcoming Presentation - Data from the ongoing Phase 1 trial will be presented at the AACR Annual Meeting 2026 on April 19, 2026, in San Diego, California, with an updated analysis beyond the published abstract [5]

Summary of Beyond Air Conference Call Company Overview - **Company**: Beyond Air (NasdaqCM: XAIR) - **Industry**: Medical Gas (specifically Nitric Oxide for pulmonary applications) Key Points and Arguments 1. **Product Innovation**: Beyond Air's system generates nitric oxide from ambient air, a unique capability that differentiates it from competitors who rely on gas cylinders. This innovation is expected to reduce costs and complexity for hospitals, enhancing safety and sustainability [2][3][18]. 2. **Market Potential**: The current U.S. market for nitric oxide is approximately $350 million, with a global market of about $700 million. The company anticipates this market will exceed $1 billion in the next five years [3]. 3. **Financial Position**: As of December 31, the company reported a cash position of $22.3 million and $22 million in debt, which is primarily synthetic royalty debt, suggesting a lower effective debt burden [3][4]. 4. **Regulatory Approvals**: The first-generation system has received FDA and CE mark approvals, with a second-generation system pending FDA approval expected by the end of the calendar year [6][10]. 5. **Growth Metrics**: The company reported a 105% year-over-year growth in quarterly revenue, indicating strong market interest and potential for future growth, particularly with the anticipated launch of the second-generation system [10][11]. 6. **Target Markets**: The primary indication for the U.S. market is for neonates with hypoxic respiratory failure, while the system is also indicated for right ventricular dysfunction post-cardiac surgery in other regions [7]. 7. **International Expansion**: Beyond Air has established partnerships in 40 countries and aims to increase its international presence, with expectations of growth in the international market over the next year [8][31]. 8. **Operational Efficiency**: The second-generation system is designed for ground and air transportation, addressing a significant limitation of the first-generation system. This capability is expected to enhance market adoption [10][30]. 9. **Sustainability Focus**: The company emphasizes sustainability by eliminating the need for gas cylinder storage and reducing emissions associated with transportation, which is increasingly important for hospitals [18]. 10. **Future Developments**: Beyond Air is exploring additional applications of nitric oxide in treating conditions such as lung infections and cancer, with ongoing studies and presentations planned at major conferences [23][26]. Additional Important Information - **Competitive Landscape**: The company faces competition from established players like Mallinckrodt, which has dominated the market since 1999. However, Beyond Air's unique offering is expected to facilitate market share gains [29]. - **Sales Model**: The company offers both a monthly fee-for-service model and capital equipment purchases, with the latter expected to perform better with the second-generation system [38]. - **Cost Management**: Operating expenses have decreased by 36% year-over-year, indicating effective cost management strategies [37]. This summary encapsulates the critical insights from the conference call, highlighting Beyond Air's innovative approach, market potential, and strategic direction in the medical gas industry.

Core Insights - Beyond Air, Inc. is a commercial-stage medical device and biopharmaceutical company focused on utilizing nitric oxide to enhance patient care [4] - The company will be represented by Steve Lisi, Chairman & CEO, at the 38th Annual Roth Conference from March 22nd to 24th, 2026 [1][2] Company Overview - Beyond Air is dedicated to improving the lives of patients with respiratory illnesses, neurological disorders, and solid tumors through the use of nitric oxide [4] - The company has received FDA approval and CE Mark for its LungFit PH system, aimed at treating term and near-term neonates with hypoxic respiratory failure [4] - Beyond Air is advancing other LungFit systems in clinical trials for severe lung infections, including viral community-acquired pneumonia and nontuberculous mycobacteria [4] Research and Development - Beyond Cancer, Ltd., an affiliate of Beyond Air, is exploring ultra-high concentrations of nitric oxide with a proprietary delivery system for targeting specific solid tumors in pre-clinical studies [5]

Core Viewpoint - Beyond Air, Inc. has terminated its proposed transaction with XTL Biopharmaceuticals regarding its NeuroNOS subsidiary, which was initially announced in January 2026 [1][2]. Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on utilizing nitric oxide to enhance patient care, particularly in respiratory illnesses, neurological disorders, and solid tumors [4]. - The company has received FDA approval and CE Mark for its LungFit PH system, aimed at treating neonates with hypoxic respiratory failure, and is advancing other LungFit systems in clinical trials for severe lung infections [4]. NeuroNOS Overview - NeuroNOS is dedicated to developing innovative treatments for neurodevelopmental and neurodegenerative disorders, utilizing small molecules that can cross the blood-brain barrier to regulate nitric oxide levels in the brain [5]. - Preclinical studies indicate elevated nitric oxide levels in children with Autism Spectrum Disorder and adults with brain-related diseases, highlighting the importance of managing nitric oxide for normal brain function [5]. Future Plans - Despite the termination of the transaction, Beyond Air remains committed to maximizing the value of the NeuroNOS platform and is exploring strategic alternatives for it while continuing to advance its core nitric oxide platform and LungFit programs [3].

Group 1 - Beyond Air Inc (NASDAQ:XAIR) is recognized as a promising penny stock, with analysts highlighting its potential in the market [1] - A recent peer-reviewed article emphasized the efficacy of high-dose inhaled nitric oxide as a therapy for respiratory illnesses, summarizing data from 27 studies [2] - The article also identified therapeutic opportunities for inhaled nitric oxide in conditions such as hospital-acquired pneumonia, tuberculosis, and post-viral fibrosis [2] Group 2 - Beyond Air has developed a nitric oxide generator and delivery platform named LungFit, with sales from its LungFit PH system increasing by 105% year-over-year to $2.2 million in the December quarter [3] - The LungFit PH system is specifically designed for treating term and near-term neonates suffering from hypoxic respiratory failure [3] - Beyond Air Inc is headquartered in Garden City, New York, and focuses on using nitric oxide for treating respiratory diseases and other medical conditions [4]

Core Insights - Beyond Air, Inc. is focused on utilizing high-dose inhaled nitric oxide (iNO) as a potential broad-spectrum antimicrobial therapy for respiratory infections, as highlighted in a recent independent review article [1][2][3] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company dedicated to improving patient outcomes in respiratory illnesses, neurological disorders, and solid tumors [4] - The company has received FDA approval and CE Mark for its LungFit PH system, which treats hypoxic respiratory failure in neonates [4] - Beyond Air is advancing other LungFit systems in clinical trials targeting severe lung infections, including viral community-acquired pneumonia and nontuberculous mycobacteria [4] Research and Development - An independent review article synthesizes data from 27 studies, demonstrating the safety and efficacy of high-dose iNO in various clinical settings, including pneumonia and COVID-19 [2] - The review outlines the unique multimodal activities of high-dose iNO, such as direct microbial killing, biofilm disruption, and inflammation reduction [2] - Future research opportunities are identified in areas like hospital-acquired pneumonia and tuberculosis, where new therapeutic tools are urgently needed [2] Market Potential - The CEO of Beyond Air expressed optimism about the recognition of high-dose iNO as a transformative treatment for respiratory infections, indicating a growing body of evidence supporting its use [3] - The publication of the review article is expected to catalyze further scientific research and accelerate clinical development of high-dose iNO [3] Product Details - Beyond Air's LungFit system is a cylinder-free delivery system capable of generating nitric oxide from ambient air at concentrations ranging from 1 ppm to 80 ppm [6] - The system is designed to replace traditional high-pressure nitric oxide cylinders, offering operational advantages in hospital settings [6][7] - LungFit can deliver nitric oxide at concentrations above 80 ppm for treating severe acute lung infections in both hospital and home settings [7]

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]