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

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

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

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

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

Core Insights - Beyond Air, Inc. is set to report its financial results for the third fiscal quarter ended December 31, 2025, on February 13, 2026 [1] - The management team will host a conference call and webcast at 8:00 AM Eastern Time on the same day [1] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on utilizing nitric oxide (NO) to enhance the lives of patients with respiratory illnesses, neurological disorders, and solid tumors [3] - The company has received FDA approval and CE Mark for its first system, LungFit PH, aimed at treating term and near-term neonates with hypoxic respiratory failure [3] - Beyond Air is advancing other LungFit systems in clinical trials for severe lung infections, including viral community-acquired pneumonia and nontuberculous mycobacteria [3] Research and Development - Beyond Cancer, Ltd., an affiliate of Beyond Air, is exploring ultra-high concentrations of NO with a proprietary delivery system to target specific solid tumors in pre-clinical studies [4]

Core Viewpoint - Beyond Air, Inc. has entered into a securities purchase agreement to raise approximately $5.0 million through a private placement of common stock and warrants, aimed at enhancing its working capital and general corporate purposes [1][2]. Group 1: Securities Offering - The company will issue 3,930,818 shares of common stock and warrants to purchase an equal number of shares at a combined purchase price of $1.272 per share, with expected gross proceeds of around $5.0 million before expenses [1]. - The warrants will have an exercise price of $1.147 per share and will be exercisable immediately upon issuance for a term of five years [1]. - Rodman & Renshaw LLC is the exclusive placement agent for this private placement, with Roth Capital Partners and D. Boral Capital serving as financial advisors [2]. Group 2: Use of Proceeds - The net proceeds from the private placement will be utilized for working capital and general corporate purposes [2]. Group 3: Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on using nitric oxide to treat respiratory illnesses, neurological disorders, and solid tumors [5]. - The company has received FDA approval and CE Mark for its LungFit PH system, which treats neonates with hypoxic respiratory failure, and is advancing other LungFit systems in clinical trials for severe lung infections [5]. - An affiliate, Beyond Cancer, Ltd., is exploring ultra-high concentrations of nitric oxide for targeting solid tumors in pre-clinical settings [6].

Core Insights - XTL Biopharmaceuticals Ltd. has announced a binding agreement to acquire 85% of NeuroNOS Ltd., a subsidiary of Beyond Air, Inc., which focuses on disease-modifying therapeutics for Autism Spectrum Disorder (ASD) and neuro-oncology [1][2] - The acquisition positions XTL as a significant player in the autism therapeutics market, addressing a critical unmet medical need as 1 in 31 U.S. children are affected by autism, with no FDA-approved disease-modifying therapies currently available [3][4] Company Overview - NeuroNOS was founded by Professor Haitham Amal, a leading autism researcher, and has strengthened its scientific leadership by adding two Nobel Laureates in Chemistry, enhancing its potential for therapeutic innovation [5][7] - The company’s drug development platform targets the underlying molecular mechanisms of autism through a proprietary family of small molecules that can cross the blood-brain barrier [8] Market Opportunity - The autism crisis has led to increased strain on healthcare systems and families, with a significant rise in cases prompting urgent calls for new therapeutic pathways and research funding from U.S. policymakers [3][4] - The U.S. government has allocated $50 million in new NIH funding for autism research initiatives, indicating a shift in regulatory priorities towards autism treatment development [4] Transaction Details - XTL will acquire 85% of NeuroNOS for a combination of cash, shares, and milestone payments totaling up to $32.5 million, with the transaction subject to shareholder approval [10][11] - The milestone payments include up to $5.5 million for clinical development and up to $26 million for achieving product sales targets [11] Scientific Validation - NeuroNOS has secured FDA Orphan Drug Designations for Phelan-McDermid Syndrome and Glioblastoma, which provide market exclusivity and expedited regulatory review upon approval [9] - Preclinical studies have shown that the platform addresses core pathological mechanisms in autism, validating nitric oxide dysregulation as a therapeutic target [8]

Core Insights - XTL Biopharmaceuticals Ltd. has announced a binding agreement to acquire 85% of NeuroNOS Ltd., a subsidiary of Beyond Air, Inc., which focuses on disease-modifying therapeutics for Autism Spectrum Disorder (ASD) and neuro-oncology [1][2] - The acquisition positions XTL as a significant player in the autism therapeutics market, addressing a critical unmet medical need as 1 in 31 U.S. children are affected by autism, with no FDA-approved disease-modifying therapies currently available [3][4] Company Overview - NeuroNOS was founded by Professor Haitham Amal, a leading autism researcher, and has strengthened its scientific leadership by adding two Nobel Laureates in Chemistry, enhancing its potential for therapeutic innovation [5][7] - The company’s drug development platform targets the underlying molecular mechanisms of autism through a proprietary family of small molecules that can cross the blood-brain barrier [8] Market Opportunity - The autism crisis has led to increased strain on healthcare systems and families, with a significant rise in cases prompting urgent calls for new therapeutic pathways and research funding from U.S. policymakers [3][4] - The U.S. government has allocated $50 million in new NIH funding for autism research initiatives, indicating a shift in regulatory priorities towards autism treatment development [4] FDA Designations and Financial Terms - NeuroNOS has secured FDA Orphan Drug Designations for Phelan-McDermid Syndrome and Glioblastoma, which provide market exclusivity and expedited regulatory review [9] - The transaction terms include XTL acquiring 85% of NeuroNOS for 19.9% of XTL's issued share capital, $1 million in cash, and milestone payments up to $32.5 million [10][11] Strategic Commitment - Both XTL and Beyond Air are committed to advancing NeuroNOS's autism treatment programs with urgency, aiming to bring innovative therapies to market [11][12] - The acquisition is seen as a pivotal moment for NeuroNOS, providing the necessary focus and funding to advance its pipeline in autism and neuro-oncology [12]

Core Insights - XTL Biopharmaceuticals is acquiring 85% of NeuroNOS, a subsidiary of Beyond Air, to enhance its position in the autism therapeutics market, which is currently underserved with no FDA-approved disease-modifying therapies available [1][2] - The acquisition is expected to provide XTL with a strong scientific foundation, including leadership from Nobel Laureates and a focus on addressing the underlying biological mechanisms of Autism Spectrum Disorder (ASD) [7][12] Industry Overview - Autism Spectrum Disorder affects approximately 1 in 31 children in the U.S., highlighting a significant public health crisis that has strained healthcare systems and families [3][4] - The U.S. government has recognized the urgency of addressing autism, allocating $50 million in new NIH funding for research initiatives, indicating a shift in regulatory priorities towards autism treatment development [4] Scientific Leadership - NeuroNOS was founded by Professor Haitham Amal, a leading autism researcher, and has recently added two Nobel Laureates, enhancing its scientific credibility and potential for innovation in autism therapeutics [5][7] - The company's research focuses on nitric oxide dysregulation, which has been linked to both autism and brain cancer, establishing a novel therapeutic target [6][8] Technology and Regulatory Status - NeuroNOS's drug development platform utilizes small molecules designed to cross the blood-brain barrier and target nitric oxide abnormalities, aiming to address core pathological mechanisms rather than just symptoms [8] - The company has secured FDA Orphan Drug Designations for Phelan-McDermid Syndrome and Glioblastoma, which provide market exclusivity and expedited regulatory review [9] Transaction Details - The acquisition terms include a 19.9% stake in XTL's post-transaction share capital, $1 million in cash, and milestone payments up to $32.5 million based on clinical and commercial achievements [10][11] - Both XTL and Beyond Air are committed to advancing NeuroNOS's autism treatment programs with urgency [11][12]