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].

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 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 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. is a commercial-stage medical device and biopharmaceutical company focused on utilizing nitric oxide to enhance patient care [3][4] - The company will participate in the ROTH 4th Annual Healthcare Opportunities Conference on October 9, 2025, where the CFO will be available for investor meetings [1][2] Company Overview - Beyond Air specializes in treatments for respiratory illnesses, neurological disorders, and solid tumors, with FDA approval for its LungFit PH system aimed at neonates with hypoxic respiratory failure [3][4] - The company is advancing other LungFit systems in clinical trials for severe lung infections, including viral pneumonia and nontuberculous mycobacteria [3][4] Product Details - The LungFit system is a cylinder-free, phasic flow generator that delivers nitric oxide at concentrations from 1 ppm to 80 ppm, designed to replace traditional high-pressure NO cylinders [5][6] - LungFit can also deliver NO at concentrations above 80 ppm for treating severe acute lung infections in hospital settings and chronic infections in home settings [6][7] Research Collaborations - Beyond Air has partnered with The Hebrew University of Jerusalem to develop treatments for autism spectrum disorder and other neurological conditions [4] - An affiliate, Beyond Cancer, Ltd., is exploring ultra-high concentrations of nitric oxide for targeting solid tumors in pre-clinical studies [4]

Core Insights - Beyond Air, Inc. is participating in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York, NY, with CEO Steve Lisi representing the company [1] - An on-demand webcast of the company's presentation will be available starting September 5, 2025, and management will be available for one-on-one meetings with investors [2] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on using nitric oxide (NO) to treat patients with respiratory illnesses, neurological disorders, and solid tumors [3] - The company has received FDA approval and CE Mark for its LungFit PH system, which treats 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 - 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 for targeting solid tumors in pre-clinical studies [4] Product Details - The LungFit system is a cylinder-free, phasic flow generator that can deliver NO from ambient air at concentrations ranging from 1 ppm to 80 ppm, designed to replace high-pressure NO cylinders [5] - LungFit can also deliver NO at concentrations above 80 ppm for treating severe acute lung infections in hospitals and chronic infections in home settings [6] - LungFit PH is approved for commercial use in the U.S., EU, and other countries, while other LungFit systems are for investigational use only [7]

Core Insights - Beyond Air has expanded its LungFit PH distribution network to 34 countries, covering a combined population of 2.7 billion people [1][3] - The company has signed new distribution agreements in Japan, South Korea, Costa Rica, Guatemala, Panama, and El Salvador [1][2] - The LungFit PH device generates nitric oxide from ambient air, eliminating the need for traditional high-pressure cylinders, thus streamlining hospital operations and reducing environmental impact [3][5] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on utilizing nitric oxide to improve patient outcomes [10][11] - The LungFit PH system is FDA-approved and designed for treating hypoxic respiratory failure in neonates, with potential applications for severe lung infections [11][12] - The company is advancing other LungFit systems in clinical trials for various respiratory and neurological conditions [11][12] 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 [5][6] - The device is compatible with ventilators and aims to replace large, high-pressure nitric oxide cylinders, providing operational benefits in hospital settings [5][6] - Beyond Air intends to offer nitric oxide treatment in home settings, enhancing accessibility for patients [6][7] Market Position - The company is well-positioned to capture opportunities in both developed and emerging healthcare markets, with hospital tender submissions already underway [3][11] - Beyond Air's distribution agreements are expected to drive significant adoption of its products in the coming years [3][11]

Core Insights - Beyond Air, Inc. has been awarded a national group purchasing agreement for therapeutic gases with Premier, Inc., effective July 15, 2025, allowing Premier members to access special pricing for the LungFit PH system and disposable NO2 Smart Filters [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 and neurological disorders [8][10] - The LungFit PH system is designed to deliver nitric oxide on demand from ambient air, providing a cylinder-free solution that improves safety and operational efficiency in healthcare settings [2][5] Product Details - The LungFit PH system can deliver NO doses ranging from 0.5 ppm to 80 ppm, with a standard delivery of 20 ppm for ventilated patients, and each Smart Filter provides 12 hours of therapy [2][5] - The system operates using only the power equivalent to a 60-watt lightbulb, minimizing nitrogen dioxide (NO2) byproduct levels [2][5] - Beyond Air's LungFit PH is approved for commercial use in multiple regions, including the U.S., EU, and Australia, while other LungFit systems are still in investigational stages [7][8] Strategic Partnerships - The agreement with Premier was facilitated by HealthCare Links, a consulting group specializing in national group purchasing organization access [4] - Premier serves a significant portion of U.S. healthcare providers, enhancing the distribution and accessibility of Beyond Air's products [3] Market Potential - The LungFit system has the potential to replace traditional high-pressure NO cylinders, significantly reducing inventory and storage needs in hospitals [5][6] - Beyond Air is also exploring the use of its technology for treating severe lung infections and chronic conditions in both hospital and home settings [6][9]

Core Insights - Beyond Air, Inc. has submitted a premarket approval supplement application to the FDA for its next-generation therapeutic nitric oxide generator, LungFit PH II, which is designed to be smaller, lighter, and fully transport-ready [3][4] - The LungFit PH II system utilizes patented Ionizer™ technology to generate unlimited on-demand nitric oxide from ambient air, ensuring compatibility with existing devices and minimal disruption for current users [5][6] - The new system aims to enhance the delivery of nitric oxide therapy for conditions such as persistent pulmonary hypertension of the newborn (PPHN), which affects approximately 1.9 per 1,000 live births and has a mortality rate ranging from 4% to 33% [11][12] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on utilizing nitric oxide to treat respiratory illnesses, neurological disorders, and solid tumors [12][13] - The company has received FDA approval for its first system, LungFit PH, which is used for treating hypoxic respiratory failure in neonates [12] - Beyond Air is advancing other LungFit systems in clinical trials for severe lung infections, including COVID-19 and nontuberculous mycobacteria [12] Product Features - LungFit PH II is designed to deliver nitric oxide at concentrations ranging from 0.5 ppm to 80 ppm, with a standard delivery of 20 ppm for ventilated patients [6][8] - The system includes a Smart Filter that provides 12 hours of therapy and can be replaced quickly, ensuring uninterrupted treatment [6] - The device operates using the equivalent power of a 60-watt lightbulb, producing low levels of nitrogen dioxide as a byproduct, which is filtered out [5][6] Market Potential - The introduction of LungFit PH II is expected to significantly enhance Beyond Air's market position and expand its reach in hospital-based nitric oxide delivery systems [7] - Nitric oxide therapy has been the standard of care for PPHN in the U.S. for over 20 years, indicating a stable market demand for effective treatment options [11] - Beyond Air aims to replace traditional high-pressure nitric oxide cylinders with its innovative system, which could lead to improved safety and operational efficiencies in hospital settings [8][9]