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]

Distribution network coverage expanded to a total of 39 countriesGARDEN CITY, N.Y., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR) (“Beyond Air” or the “Company”), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, today announced the recent signing of several key international distribution agreements for LungFit® PH, expanding its network to include Germany, Brazil, Austria, the Netherland ...

As filed with the Securities and Exchange Commission on December 11, 2025 Registration No. 333-291699 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 Beyond Air, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 3841 47-3812456 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Numbe ...

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]

Washington, D.C. 20549 _________________________________ As filed with the Securities and Exchange Commission on November 21, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION FORM S-1 REGISTRATION STATEMENT Under The Securities Act of 1933 _________________________________ Beyond Air, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 3841 47-38 ...

Financial Data and Key Metrics Changes - Revenue for the fiscal second quarter increased by 128% year-over-year, reaching $1.8 million, up from $0.8 million in the same period last year [4][15] - The company reported a gross loss of $0.3 million for the fiscal second quarter, an improvement from a loss of $1.1 million for the same period last year [16] - Net loss attributed to common stockholders was $7.9 million, or a loss of $1.25 per share, compared to a net loss of $13.4 million, or a loss of $5.67 per share, for the same quarter last year [18] Business Line Data and Key Metrics Changes - The company introduced a capital purchase sales model in the U.S. and had its first hospital purchase of LungFit PH [6] - The sales pipeline remains robust, with substantial opportunities across the U.S. as awareness of LungFit PH builds [4] Market Data and Key Metrics Changes - The company added new distribution partnerships in Japan, South Korea, Mexico, Costa Rica, Guatemala, Panama, and El Salvador, expanding its international coverage to 35 countries [10][11] - The company anticipates reaching its goal of 60 countries under partnership by calendar 2026 [11] Company Strategy and Development Direction - The company is preparing for the launch of its second-generation LungFit system, expected in late calendar 2026, pending FDA approval [8] - A national group purchasing agreement for therapeutic gases with Premier has been awarded, providing access to nearly 3,000 hospitals [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trajectory of growth post-launch of the second-generation LungFit PH, anticipating a steeper growth curve [23] - The company is navigating complexities in hospital sales cycles, with expectations for sequential growth to resume in upcoming quarters [4] Other Important Information - The company raised $12 million in debt and plans to file a registration statement for an additional $20 million through an equity line of credit [5] - The company reported a 37% reduction in total operating expenses year-over-year, down to just above $7.4 million from $11.7 million [16] Q&A Session Summary Question: Expected growth drivers leading into the potential approval of the second-generation LungFit PH - Management believes the trajectory post-launch will be significantly steeper, with international expansion and the introduction of a capital purchase model as key growth drivers [23][24] Question: Comments on timing for commercialization of the second-gen LungFit PH - Management indicated that FDA timing is not the limiting factor, but supply chain issues are affecting the timeline [26] Question: Comparison between the new model and prior ones - The second-generation machine will be about 60% the size of the original, with improved user interface and longer maintenance intervals [28][29] Question: Insights on international deals and pricing models - The international model involves selling to distributors who then use various models, including capital equipment purchases and disposables [33] Question: Update on the updated guidance of $8 million-$10 million - Management noted that the transition in leadership may cause some disruption, but the revenue target is achievable based on current performance [35][36]

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]

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]