Core Insights - Beyond Air, Inc. has expanded its international distribution network for the LungFit PH system, now covering 18 countries following new agreements in France, Turkey, Romania, and Morocco [1][2] - The company anticipates a rapid commercial ramp-up in international markets, leveraging established distribution partners with medical device infrastructure [2] Distribution Agreements - Recent agreements include partnerships with EUROCARE for France, Medelart Healthcare for Turkey, Abb Neopuls for Romania, and OXYPLUS for Morocco [1][2] - The current distribution partners also include Getz Healthcare across multiple Asian countries, Saudi Health Services CO in Saudi Arabia, and MDC Care Medical Trading in the UAE and surrounding regions [2] Product Overview - LungFit PH is a tankless system that generates nitric oxide (NO) from room air, enhancing operational efficiency and supporting sustainability in hospital settings [3][4] - The device can deliver NO at concentrations ranging from 1 ppm to 80 ppm, with potential applications in treating severe acute lung infections and chronic lung infections [4][5] Regulatory Status - LungFit PH is approved for commercial use in the United States, European Union, Australia, Thailand, and New Zealand [6] - The system is designated as a medical device by the U.S. FDA and is intended for use in treating hypoxic respiratory failure in neonates [9] Therapeutic Applications - Nitric oxide plays a critical role in various biological functions and is used in treating conditions such as adult respiratory distress syndrome and persistent pulmonary hypertension [7] - Exogenous inhaled NO is believed to have antimicrobial properties, potentially effective against a range of pathogens, including multi-drug-resistant strains [8]

GARDEN CITY, N.Y., March 06, 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 that Steve Lisi, Chairman and Chief Executive Officer of Beyond Air, will participate in the Roth 37th Annual Growth Stock Conference being held March 16-18, 2025 in Laguna, CA and the Jones Healthcare and Technology Innovatio ...

VANCOUVER, BC and KIBBUTZ YIFAT, Israel, Feb. 28, 2025 (GLOBE NEWSWIRE) -- Beyond Oil Ltd. (CSE: BOIL) (OTCQB: BEOLF) (Frankfurt: UH9) (“Beyond Oil” or the “Company”), a food-tech innovation company dedicated to reducing health risks associated with fried food while lowering operational costs, minimizing waste, and enhancing sustainability, is pleased to announce that it has signed a distribution agreement (the “Agreement”) with Deep Frying Solutions Pvt Ltd, a newly formed company based in Gujarat, India ( ...

VANCOUVER, B.C. and KIBBUTZ YIFAT, ISRAEL, Feb. 26, 2025 (GLOBE NEWSWIRE) -- Beyond Oil Ltd. (CSE: BOIL) (OTCQB: BEOLF) (Frankfurt: UH9) (“Beyond Oil” or the “Company”), a food-tech innovation company dedicated to reducing health risks associated with fried food while lowering operational costs, minimizing waste, and enhancing sustainability, is pleased to announce its entry into the African market through a new distribution agreement with Minrosolve Proprietary in South Africa. This agreement marks Beyond ...

Core Insights - Beyond Oil Ltd. has successfully delivered its first shipment of proprietary oil treatment products to T&J Oil Pty Ltd. as part of a five-year distribution agreement aimed at expanding into the Australian market [1][2][3] - The initial shipment consisted of 5.4 tonnes of products and is part of a minimum purchase commitment of approximately US$4.9 million [2] - The partnership with T&J Oil is expected to transform the food service industry in Australia by providing healthier and more sustainable frying solutions [3] Company Overview - Beyond Oil Ltd. is a food-tech innovation company focused on reducing health risks associated with fried food while enhancing sustainability and lowering operational costs [1][4] - The company's patented technology has received regulatory clearances from the FDA and Health Canada, significantly reducing harmful compounds in frying oil [4] - Beyond Oil addresses the widespread practice of reusing frying oil, which poses health risks such as links to cancer and cardiovascular diseases, by offering solutions that improve food quality and reduce environmental impact [4]

Financial Performance - Revenues for the fiscal third quarter ended December 31, 2024, were $1.1 million, a 34% increase compared to $0.8 million for the previous quarter ended September 30, 2024[10] - Total revenues for the three months ended December 31, 2024, were $1,072,000, compared to $391,000 for the same period in 2023, representing a 174% increase[27] - Gross loss for the three months ended December 31, 2024, was $(215,000), an improvement from $(356,000) in the same period of 2023[27] - Net loss attributable to Beyond Air, Inc. for the three months ended December 31, 2024, was $(13,032,000), compared to $(16,220,000) for the same period in 2023, showing a 20% improvement[27] - Comprehensive loss attributable to Beyond Air, Inc. for the three months ended December 31, 2024, was $(13,093,000), compared to $(16,229,000) for the same period in 2023, indicating a 19% improvement[27] Expenses - Research and development expenses decreased to $3.0 million for the quarter ended December 31, 2024, down from $6.8 million for the same period in 2023[12] - Selling, general and administrative expenses were $7.7 million for the quarter ended December 31, 2024, a decrease from $9.8 million in the prior year[13] - Research and development expenses for the three months ended December 31, 2024, were $(3,005,000), down from $(6,838,000) in the same period of 2023, indicating a 56% reduction[27] - Selling, general and administrative expenses for the three months ended December 31, 2024, were $(7,732,000), compared to $(9,768,000) in the same period of 2023, reflecting a 21% decrease[27] Cash and Assets - Cash burn for the fiscal quarter ended December 31, 2024, was $7.6 million, excluding financing impacts[14] - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities of $10.9 million, with total debt outstanding of $11.8 million[15] - Total current assets decreased to $19,344,000 as of December 31, 2024, from $43,936,000 as of March 31, 2024, a decline of 56%[26] - Cash and cash equivalents decreased to $4,601,000 as of December 31, 2024, from $11,378,000 as of March 31, 2024, a decline of 60%[26] - Total liabilities decreased to $15,763,000 as of December 31, 2024, from $29,775,000 as of March 31, 2024, a reduction of 47%[26] Market and Regulatory Developments - The company received CE Mark for LungFit PH in Europe, allowing access to a significant portion of the global market, and anticipates initial commercial shipments in 2025[4] - Six new hospital starts in the U.S. were recorded in the quarter ended December 31, 2024, indicating growing demand for LungFit PH[5] - A $1 million milestone payment was triggered by the CE Mark certification from Getz Healthcare, with double-digit royalty payments expected based on LungFit PH net sales[8] - The company expects to have regulatory approvals in eight countries under the partnership with Getz Healthcare by the end of the calendar year[5] Future Outlook - Topline data from the Phase 1b trial for the NeuroNOS program is anticipated late in calendar 2025 or early 2026[8] - The weighted average number of shares outstanding for the three months ended December 31, 2024, was 88,074,511, compared to 32,462,476 for the same period in 2023[27]

Financial Data and Key Metrics Changes - Revenue for Q3 2025 was $1.1 million, compared to $0.4 million a year ago, indicating significant growth [24] - Gross profit loss was $0.2 million for Q3 2025, an improvement from a loss of $0.4 million in the same period last year [24] - Net loss attributed to common stockholders was $13 million, or a loss of $0.15 per share, compared to a net loss of $16.2 million, or a loss of $0.50 per share, in Q3 2024 [27] - Net cash burn for the quarter was $7.6 million, over 30% lower than the previous quarter [28] - As of December 31, 2024, the company had cash, cash equivalents, and marketable securities of $10.9 million [29] Business Line Data and Key Metrics Changes - The commercial team signed six new hospital contracts and renewed two contracts during the quarter [8] - Positive feedback from existing customers on the LungFit PH device is driving new engagements [10] - The company is enhancing its marketing efforts and customer engagement processes [10] Market Data and Key Metrics Changes - The LungFit PH received CE Mark approval, allowing marketing in the EU and other countries, which triggered a $1 million milestone payment from Getz Healthcare [14] - Getz Healthcare is ahead of schedule in securing market authorization in Australia [15] - The company is seeing high distributor interest in various global markets, including the Middle East [15] Company Strategy and Development Direction - The company aims to strengthen its commercial infrastructure and customer engagement to drive revenue growth [9] - Plans to submit a PMA supplement for the next-generation LungFit PH system are underway, with expectations for significant market share growth [12][17] - The company is focusing on expanding its presence in international markets, anticipating that ex-U.S. markets will become larger than the U.S. market in the long term [77] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing momentum in revenue growth and customer engagement [9] - The company is preparing for potential challenges with the FDA regarding the PMA submission process [41][72] - Management believes that the updated LungFit PH is poised to capture significant market share in both the U.S. and global markets [16][78] Other Important Information - Research and development expenses decreased to $3 million from $6.8 million year-over-year, primarily due to reduced salaries and stock-based compensation [25] - SG&A expenses also decreased to $7.7 million from $9.8 million year-over-year [26] - The company is committed to improving profitability while enhancing patient care through nitric oxide therapies [23] Q&A Session Summary Question: Impact of CE Mark on revenues - Management indicated that the CE Mark will have a small impact in the March quarter, with more significant effects expected in subsequent quarters [34] Question: Changes in commercial organization - Management highlighted a cultural shift and improved customer service as key drivers of recent progress [46][48] Question: PMA submission timeline - Management noted uncertainty regarding the timeline for FDA review due to potential staffing changes at the agency [41] Question: Annualized contract revenue update - Management refrained from providing specific updates on annualized contract revenue but indicated positive growth trends [55] Question: Importance of U.S. vs. ex-U.S. markets - Management expects ex-U.S. markets to become larger than the U.S. market in the long term, driven by the unique advantages of the LungFit PH system [77] Question: Hospital contract turnaround times - Management confirmed that most contracts lead to customer engagement within 30 to 45 days, with some exceptions [85][89] Question: Long-term debt status - Management clarified that the company has $11.5 million in long-term debt, with payments starting in October 2026 [92] Question: Next-gen device PMA submission - Management indicated that the next-gen device PMA submission would likely cover both NICU and cardiac indications [95]

Beyond Air, Inc. (XAIR) came out with a quarterly loss of $0.15 per share versus the Zacks Consensus Estimate of a loss of $0.18. This compares to loss of $0.50 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 16.67%. A quarter ago, it was expected that this company would post a loss of $0.30 per share when it actually produced a loss of $0.28, delivering a surprise of 6.67%.Over the last four quarters, the company has surpasse ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________to _________ Commission File Number: 001-38892 BEYOND AIR, INC. (Exact name of registrant as specified in its charter) | Delaware | 47-3812456 | | --- | --- ...

Revenues increased 34% compared to the previous quarter ended September 30, 2024; and exceeded $1 million Received CE Mark for LungFit PH® in Europe and Market Authorization in Australia; international shipments to commence later this year Conference call at 4:30 p.m. ET today, February 10th GARDEN CITY, New York, Feb. 10, 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 o ...