Core Insights - Beyond Air, Inc. has announced a leadership change with Steve Lisi resigning as CEO and Robert Goodman appointed as the new CEO effective March 27, 2026 [1][2][3] Leadership Transition - Steve Lisi has led Beyond Air for nine years, successfully guiding the development and market launch of the LungFit PH system [2] - Robert Goodman, previously the Chief Commercial Officer, has been appointed as CEO, bringing extensive experience in commercial and operational roles within the healthcare sector [1][3][4] - The company anticipates a seamless transition with no disruption to operations or customer relationships [6] Company Background - Beyond Air is focused on utilizing nitric oxide to improve patient outcomes in respiratory illnesses, neurological disorders, and solid tumors [7] - The company has received FDA approval and CE Mark for its LungFit PH system, aimed at treating neonates with hypoxic respiratory failure [7]

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]

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]

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].