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]

Summary of Beyond Air (NasdaqCM:XAIR) FY Conference Call Company Overview - **Company**: Beyond Air - **Ticker**: XAIR - **Industry**: Medical Gas (Nitric Oxide) Key Points Product and Technology - **Nitric Oxide (NO)**: A medical gas used primarily as a pulmonary vasodilator to treat conditions like hypoxic respiratory failure in newborns and right ventricular dysfunction post-cardiac surgery [4][5] - **Unique Selling Proposition**: Beyond Air's system generates nitric oxide from room air, eliminating the need for heavy, hazardous cylinders used by competitors, making it more sustainable and cost-effective for hospitals [6][8][10] Market Challenges and Strategy - **Slow Uptake in U.S. Market**: Initial launch difficulties due to the pandemic and compatibility issues with upgraded ventilators delayed market penetration [11][12] - **First-Generation System Limitations**: The first-generation device lacks inter-hospital transport capabilities, which is a drawback in the U.S. market [13] - **Second-Generation Device**: Anticipated FDA approval by the end of 2026, designed to be smaller, user-friendly, and suitable for transport in ambulances and aircraft [14][16] Market Potential - **International Market**: Beyond Air has established distribution partnerships in 40 countries, with expectations of significant revenue growth from international markets over the next 12 to 24 months [18][25] - **Market Size Comparison**: The international market for nitric oxide is projected to be double that of the U.S. market in terms of dollar value over the next five to seven years [21] Clinical Pipeline - **Infectious Diseases**: Ongoing studies on the use of nitric oxide for treating lung infections and COVID-19, with positive results from previous trials [27][29] - **Cancer Treatment**: Research on high-dose nitric oxide for cancer treatment shows promising survival signals in refractory patients [31][34] - **Neurological Conditions**: Preclinical studies on conditions like autism and glioblastoma, with orphan drug status granted by the FDA [35][36] Intellectual Property - **Patent Portfolio**: Strong patent protection for the LungFit machine and related technologies, with patents extending to 2044 [37][39] Financial Position - **Capital Position**: Recent funding has strengthened the balance sheet, providing enough cash to reach the next-generation product approval, with potential needs for additional capital for a proper launch [40][41] Conclusion - Beyond Air is positioned to capture significant market share in the nitric oxide space with its innovative technology and expanding international presence, despite initial challenges in the U.S. market. The company is actively pursuing clinical applications in infectious diseases, cancer, and neurological conditions, supported by a robust patent portfolio and a solid financial foundation.

Core Insights - Beyond Air, Inc. has appointed Dan Moorhead as Chief Financial Officer, effective January 5, 2026, succeeding Duke Dewrell, who served as interim CFO since November 2025 [1][2] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on utilizing nitric oxide (NO) to enhance patient care, particularly for respiratory illnesses, neurological disorders, and solid tumors [5][6] - 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 [5] Leadership Appointment - Dan Moorhead brings over 20 years of finance leadership experience, having previously served as CFO of Zynex, Inc., where he supported significant commercial expansion [3] - Moorhead expressed enthusiasm about joining Beyond Air at a critical time, particularly with the upcoming FDA approval of the second generation LungFit PH and its commercial launch [2][3] Inducement Stock Option - Upon his appointment, Moorhead was granted an inducement stock option for 70,000 shares of the company's common stock, exercisable at the last reported sale price on December 31, 2025 [4] - The stock option has a ten-year term and will vest over four years, with 25% vesting on the first anniversary and the remainder in three equal installments [4] Product Development - Beyond Air is advancing its LungFit systems in clinical trials for severe lung infections, including viral community-acquired pneumonia and nontuberculous mycobacteria [5][6] - The company is also collaborating with The Hebrew University of Jerusalem on a pre-clinical program for treating autism spectrum disorder and other neurological disorders [6]

Core Insights - Beyond Air, Inc. has expanded its international distribution network for LungFit PH to 39 countries, covering a population of over three billion people [1][2] - The company aims to leverage its unique nitric oxide delivery technology to gain significant market share in key international markets [2] - LungFit PH is designed to generate nitric oxide from ambient air, streamlining hospital operations and reducing environmental impact [3][6] 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 [4] - The company has received FDA approval and CE Mark for LungFit PH, which is intended for treating neonates with hypoxic respiratory failure [4][8] - Beyond Air is advancing other LungFit systems in clinical trials for severe lung infections, including viral community-acquired pneumonia and nontuberculous mycobacteria [4] Product Details - LungFit PH is a cylinder-free, phasic flow generator that can deliver nitric oxide at concentrations ranging from 1 ppm to 80 ppm [6] - The device is compatible with ventilators and aims to replace traditional high-pressure nitric oxide cylinders, offering operational benefits such as reduced inventory and improved safety [6][7] - Beyond Air plans to extend the use of LungFit technology for home treatment of chronic lung infections [7] Research and Development - The company has partnered with The Hebrew University of Jerusalem to develop treatments for autism spectrum disorder and other neurological conditions [5] - Beyond Cancer, Ltd., an affiliate of Beyond Air, is exploring high concentrations of nitric oxide for targeting solid tumors in pre-clinical studies [5]

Core Points - Doug Larson has resigned as Chief Financial Officer of Beyond Air, Inc. to pursue another opportunity, with an interim CFO to be appointed [1][4] - Larson's leadership was crucial in transitioning Beyond Air to a commercial business, particularly with the launch of LungFit PH and clinical research subsidiaries [2] - Beyond Air is actively searching for a permanent successor for the CFO position [1] Company Overview - Beyond Air, Inc. 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, aimed at treating neonates with hypoxic respiratory failure [5][9] - Beyond Air is advancing other LungFit systems in clinical trials for severe lung infections, including COVID-19 [5][8] Product Details - LungFit is a cylinder-free, phasic flow generator that delivers nitric oxide at concentrations from 1 ppm to 80 ppm, offering operational advantages in hospital settings [7] - The system is designed to replace high-pressure nitric oxide cylinders, improving safety and reducing storage requirements [7] - Beyond Air aims to provide nitric oxide treatment in home settings, particularly for chronic lung infections [8] Research and Development - Beyond Air has partnered with The Hebrew University of Jerusalem to develop treatments for autism spectrum disorder and other neurological disorders [6] - Beyond Cancer, an affiliate of Beyond Air, is investigating the use of ultra-high concentrations of nitric oxide for targeting solid tumors [12] - NeuroNOS, another affiliate, focuses on therapies for neurodevelopmental and neurodegenerative disorders by regulating nitric oxide levels in the brain [13]

Core Insights - Beyond Air, Inc. reported a significant revenue increase of 128% year over year, reaching $1.8 million for the fiscal quarter ended September 30, 2025, compared to $0.8 million for the same period last year [5][10] - The company appointed Bob Goodman as Interim Chief Commercial Officer to lead its commercial strategy following the departure of David Webster [3][5] - Beyond Air raised $12 million in debt financing, resulting in a proforma cash balance of $22.9 million as of September 30, 2025, which is expected to support operations into calendar 2027 [9][16] - The company updated its fiscal year 2026 revenue guidance to a range of $8 million to $10 million [17] Financial Performance - Revenue for the fiscal quarter ended September 30, 2025, was $1.8 million, a 128% increase from $0.8 million in the same quarter of 2024 [10] - Gross loss decreased to $0.3 million for the quarter, down from a gross loss of $1.1 million in the prior year, attributed to sales growth and one-time costs [10][15] - Research and development expenses were $2.5 million, down from $4.6 million in the same quarter of 2024, primarily due to reduced salaries and development costs [11] - Selling, general, and administrative expenses decreased to $4.9 million from $7.2 million year-over-year, reflecting cost management efforts [12] Commercial Strategy and Developments - The company is expanding its global distribution network for LungFit PH, now covering 35 countries with a combined population of 2.8 billion [5] - Beyond Air achieved certification for the Medical Device Single Audit Program (MDSAP), enhancing its compliance across multiple international markets [5] - The U.S. Patent and Trademark Office granted a design patent allowance for the second-generation LungFit PH, extending protection through 2040 [5] Regulatory and Clinical Updates - The company is preparing for regulatory approvals outside the U.S. and anticipates FDA approval for its second-generation LungFit PH by the end of calendar 2026 [4] - The PMA supplement for the second-generation LungFit PH was submitted to the U.S. FDA in June 2025 [14] - The company is advancing clinical trials for its investigational therapies, including BA-101 for Glioblastoma and BA-102 for Phelan-McDermid Syndrome, both of which received Orphan Drug Designation from the FDA [14] Upcoming Events - Beyond Air will participate in the AARC Annual Congress from December 6 to 8, 2025, in Phoenix, AZ [5]

Core Viewpoint - Beyond Air, Inc. has secured financing agreements with Streeterville Capital, providing up to $32 million to support its commercial expansion and potential profitability [2][3]. Financing Agreements - The company entered into a $12 million promissory note with a 15% annual interest rate, maturing in 24 months, with no payments due in the first year [3]. - Additionally, a $20 million Equity Line of Credit (ELOC) allows the company to sell newly issued shares over 24 months, with proceeds designated for various corporate purposes [4]. Financial Position - As of September 30, 2025, Beyond Air reported proforma cash and equivalents totaling $22.9 million, which includes the $12 million from the promissory note [1]. Strategic Goals - The financing is aimed at accelerating the commercial expansion of LungFit PH, with expectations of driving sales growth and achieving profitability by the anticipated launch of a second-generation product by the end of 2026 [3]. Company Overview - Beyond Air is focused on developing medical devices and biopharmaceuticals utilizing nitric oxide to treat respiratory illnesses and other conditions [6]. - The company has received FDA approval for its LungFit PH system, which is designed for treating neonates with hypoxic respiratory failure [6][10].

Core Insights - Beyond Air, Inc. will report its financial results for the second fiscal quarter ended September 30, 2025, on November 10, 2025, with a conference call scheduled for 4:30 PM ET 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] Partnerships and Research Initiatives - The company has partnered with The Hebrew University of Jerusalem to develop a pre-clinical program for treating autism spectrum disorder and other neurological disorders [4] - Beyond Cancer, Ltd., an affiliate of Beyond Air, is exploring ultra-high concentrations of NO with a proprietary delivery system targeting specific solid tumors in pre-clinical studies [4]