Latest news with #BeyondAir
Business Insider
13-07-2025
- Business
- Business Insider
Upcoming Stock Splits This Week (July 14 to July 18)
These are the upcoming stock splits for the week of July 14 to July 18, based on TipRanks' Stock Splits Calendar. For those unfamiliar, a stock split is when a company multiplies its outstanding shares, granting extra shares to current shareholders, yet the company's total market value stays exactly the same. This typically lowers the share price, making the stock more affordable and, potentially, more appealing to a wider pool of retail investors. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. On the flip side, some companies take a different route with a reverse stock split. Instead of dividing shares, they combine them, shrinking the overall share count and increasing the price per share. The market value doesn't budge, but this move often helps companies satisfy exchange listing requirements and avoid delisting. Moves like these, whether designed to attract investors or simply to maintain a stock exchange listing, often serve as important signals for market-savvy traders. Let's take a look at the upcoming stock splits for the week. Beyond Air (XAIR) – Beyond Air focuses on developing inhaled nitric oxide therapies aimed at treating respiratory and infectious diseases. On June 20, shareholders approved a 1-for-20 reverse stock split, which is scheduled to take effect before the market opens on July 14. The primary goal of this split is to lift the company's share price above Nasdaq's $1 minimum, allowing Beyond Air to regain compliance with exchange listing requirements. Fusion Fuel Green (HTOO) – Headquartered in Ireland, Fusion Fuel is working on advancing green hydrogen production through solar-powered PEM electrolyzers. On June 25, the company's board and shareholders approved a 1-for-35 reverse stock split, set to take effect at market open on July 14. The move is intended to bring Fusion Fuel's share price back in line with Nasdaq's minimum bid price requirements. Lazydays Holdings (GORV) – Lazydays operates one of the largest networks of RV dealerships and service centers across the U.S., offering new and pre-owned recreational vehicles, parts, and maintenance solutions. On July 10, the board approved a 1-for-30 reverse stock split, which became effective on July 11, with trading on a split-adjusted basis beginning July 14, 2025. The split is intended to raise the company's share price and help Lazydays comply with Nasdaq's minimum bid price requirement. NextCure (NXTC) – NextCure is a biotechnology company focused on developing immuno-oncology therapies for cancer. On June 25, shareholders approved a 1-for-12 reverse stock split, which will take effect before the market opens on July 14, 2025. The purpose of the split is to raise the stock price to satisfy exchange listing requirements. Passage Bio Inc (PASG) – Passage Bio is a clinical-stage biotechnology company in the U.S., specializing in the development of one-time gene therapies for neurodegenerative diseases, such as its PBFT02 program. On May 28, shareholders approved a 1-for-20 reverse stock split, scheduled to take effect on July 14. The split is intended to help the company meet Nasdaq's $1.00 minimum bid price requirement. TipRanks Stock Splits Calendar.
Business Insider
12-07-2025
- Business
- Business Insider
Beyond Air trading halted, news pending
19:50 EDT Beyond Air (XAIR) trading halted, news pending Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.
Yahoo
18-06-2025
- Business
- Yahoo
Beyond Air Inc (XAIR) (Q4 2025) Earnings Call Highlights: Revenue Soars Amidst Strategic Global ...
Revenue: Increased 220% to $3.7 million for the fiscal year ended March 31, 2025, compared with $1.2 million for the previous year. Gross Profit: Loss of $1.7 million for fiscal year 2025 compared to a loss of $1.3 million in fiscal year 2024. Cost of Revenue: $5.4 million for fiscal year 2025, up from $2.5 million in fiscal year 2024. Research and Development Expenses: Decreased to $16.9 million from $24.4 million in the previous fiscal year. SG&A Expenses: Decreased to $26 million from $37.3 million in the previous fiscal year. Net Loss: $46.6 million or $0.69 per share, compared to $60.2 million or $1.82 per share in the previous fiscal year. Net Cash Burn: $44.1 million, a reduction of over 28% from the previous year. Cash, Cash Equivalents, and Marketable Securities: $6.9 million as of March 31, 2025. Warning! GuruFocus has detected 3 Warning Signs with XAIR. Release Date: June 17, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Beyond Air Inc (NASDAQ:XAIR) reported a 220% increase in revenue for the fiscal year ended March 31, 2025, reaching $3.7 million compared to $1.2 million the previous year. The company has provided revenue guidance of $12 million to $16 million for the fiscal year ending March 31, 2026, indicating strong growth expectations. Beyond Air Inc (NASDAQ:XAIR) has established a solid customer base in key US regions, with several hospitals renewing contracts and new hospital starts. The company has expanded its international presence, securing distribution agreements in over two dozen countries, including India, Italy, and Israel. NeuroNOS, a subsidiary of Beyond Air Inc (NASDAQ:XAIR), received Orphan Drug Designation from the US FDA for its lead investigational therapy, BA-102, for Phelan-McDermid syndrome. Despite revenue growth, Beyond Air Inc (NASDAQ:XAIR) reported a net loss of $46.6 million for the fiscal year ended March 31, 2025. The cost of revenue exceeded revenue, primarily due to depreciation of LungFit devices and one-time upgrade costs. Research and development expenses, although reduced, were still significant at $16.9 million for fiscal year 2025. The company faces challenges in the international market, with longer tender processes and regulatory hurdles in some countries. Beyond Air Inc (NASDAQ:XAIR) is not yet promoting its second-generation LungFit PH II system until FDA approval is obtained, which could delay potential market expansion. Q: Is the approval of LungFit 2.0 included in the fiscal year '26 guidance, and how might it affect hospital interest? A: Steven Lisi, CEO: The fiscal '26 guidance does not include the second-generation system. We focus on promoting Gen 1 until approval is received for Gen 2. Some hospitals are interested in Gen 1 immediately, while others may wait for Gen 2. Q: Can you provide insights into the international market trends for LungFit PH? A: Steven Lisi, CEO: It's early to see trends as initial shipments are for demonstration purposes. The tender process outside the US takes longer, but we expect significant international contributions in the latter half of fiscal 2026. Q: What is the expected timeline for FDA approval of LungFit PH II, and how will the launch be managed? A: Steven Lisi, CEO: We avoid exact timing due to current FDA upheavals. Approval will take a few months, and post-approval, we will scale up manufacturing to meet demand. Q: What factors could influence reaching the higher end of the $12 million to $16 million revenue guidance for fiscal 2026? A: Steven Lisi, CEO: A few large contracts or international regulatory approvals could significantly impact revenue. We are confident in reaching the low end and have several initiatives that could push us higher. Q: How are geopolitical factors affecting Beyond Air's global operations? A: Steven Lisi, CEO: Geopolitical issues have minimal impact. Most manufacturing is US-based, and tariffs have a low single-digit impact on costs. Internationally, we are excited about opportunities in various countries, including Ukraine and Israel. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
18-06-2025
- Business
- Yahoo
Beyond Air Inc (XAIR) (Q4 2025) Earnings Call Highlights: Revenue Soars Amidst Strategic Global ...
Revenue: Increased 220% to $3.7 million for the fiscal year ended March 31, 2025, compared with $1.2 million for the previous year. Gross Profit: Loss of $1.7 million for fiscal year 2025 compared to a loss of $1.3 million in fiscal year 2024. Cost of Revenue: $5.4 million for fiscal year 2025, up from $2.5 million in fiscal year 2024. Research and Development Expenses: Decreased to $16.9 million from $24.4 million in the previous fiscal year. SG&A Expenses: Decreased to $26 million from $37.3 million in the previous fiscal year. Net Loss: $46.6 million or $0.69 per share, compared to $60.2 million or $1.82 per share in the previous fiscal year. Net Cash Burn: $44.1 million, a reduction of over 28% from the previous year. Cash, Cash Equivalents, and Marketable Securities: $6.9 million as of March 31, 2025. Warning! GuruFocus has detected 3 Warning Signs with XAIR. Release Date: June 17, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Beyond Air Inc (NASDAQ:XAIR) reported a 220% increase in revenue for the fiscal year ended March 31, 2025, reaching $3.7 million compared to $1.2 million the previous year. The company has provided revenue guidance of $12 million to $16 million for the fiscal year ending March 31, 2026, indicating strong growth expectations. Beyond Air Inc (NASDAQ:XAIR) has established a solid customer base in key US regions, with several hospitals renewing contracts and new hospital starts. The company has expanded its international presence, securing distribution agreements in over two dozen countries, including India, Italy, and Israel. NeuroNOS, a subsidiary of Beyond Air Inc (NASDAQ:XAIR), received Orphan Drug Designation from the US FDA for its lead investigational therapy, BA-102, for Phelan-McDermid syndrome. Despite revenue growth, Beyond Air Inc (NASDAQ:XAIR) reported a net loss of $46.6 million for the fiscal year ended March 31, 2025. The cost of revenue exceeded revenue, primarily due to depreciation of LungFit devices and one-time upgrade costs. Research and development expenses, although reduced, were still significant at $16.9 million for fiscal year 2025. The company faces challenges in the international market, with longer tender processes and regulatory hurdles in some countries. Beyond Air Inc (NASDAQ:XAIR) is not yet promoting its second-generation LungFit PH II system until FDA approval is obtained, which could delay potential market expansion. Q: Is the approval of LungFit 2.0 included in the fiscal year '26 guidance, and how might it affect hospital interest? A: Steven Lisi, CEO: The fiscal '26 guidance does not include the second-generation system. We focus on promoting Gen 1 until approval is received for Gen 2. Some hospitals are interested in Gen 1 immediately, while others may wait for Gen 2. Q: Can you provide insights into the international market trends for LungFit PH? A: Steven Lisi, CEO: It's early to see trends as initial shipments are for demonstration purposes. The tender process outside the US takes longer, but we expect significant international contributions in the latter half of fiscal 2026. Q: What is the expected timeline for FDA approval of LungFit PH II, and how will the launch be managed? A: Steven Lisi, CEO: We avoid exact timing due to current FDA upheavals. Approval will take a few months, and post-approval, we will scale up manufacturing to meet demand. Q: What factors could influence reaching the higher end of the $12 million to $16 million revenue guidance for fiscal 2026? A: Steven Lisi, CEO: A few large contracts or international regulatory approvals could significantly impact revenue. We are confident in reaching the low end and have several initiatives that could push us higher. Q: How are geopolitical factors affecting Beyond Air's global operations? A: Steven Lisi, CEO: Geopolitical issues have minimal impact. Most manufacturing is US-based, and tariffs have a low single-digit impact on costs. Internationally, we are excited about opportunities in various countries, including Ukraine and Israel. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
17-06-2025
- Health
- Yahoo
Beyond Air Submits FDA PMA Supplement for Next Generation LungFit® PH
LungFit PH II's smaller, lightweight, transport-ready design is expected to open the entirety of the NO market Final design based upon substantial feedback from respiratory therapists across the countryGARDEN CITY, N.Y., June 16, 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 submission of a premarket approval (PMA) supplement application to the U.S. Food and Drug Administration (FDA) for LungFit PH II, the next-generation therapeutic nitric oxide generator. Beyond Air has developed its LungFit PH II system to be smaller, lighter and fully transport-ready — while delivering all the breakthrough features of the currently FDA-approved version from the Company's therapeutic platform of nitric oxide generators targeting pulmonary disease. The new system uses the same Smart Filter and accessories as the first-generation device, ensuring continuity, streamlined logistics, and minimal disruption for existing customers. The LungFit PH platform uses the Company's patented Ionizer™ technology to generate unlimited on-demand nitric oxide from ambient air, which is then able to be delivered directly to a ventilator circuit, regardless of dose or flow. The LungFit PH system uses the equivalent power of a 60-watt lightbulb to ionize the nitrogen and oxygen molecules, forming nitric oxide with low levels of nitrogen dioxide (NO2) created as a byproduct. The gas then passes through a Smart Filter, which removes the toxic NO2 from the internal circuit. For the treatment of PPHN, the novel LungFit PH system is designed to deliver NO doses consistent with the current standard of care for delivery of 20 ppm NO, with a range of 0.5 ppm – 80 ppm (low concentration NO), for ventilated patients. Each Smart Filter provides 12 hours of therapy regardless of ventilator demands and can be replaced in seconds for uninterrupted treatment. 'We are pleased to announce that development of our transport-ready LungFit PH II has resulted in a NO system which we believe is far superior to legacy systems currently available in the market. While our first-generation system already delivers key advantages to hospitals, this next-generation device raises the bar with a reduced weight and footprint, simplified operation, longer service interval, and full compatibility with both air and ground transport. It also includes an automated backup system that retains most primary system capabilities,' said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. 'Once approved, we are confident that the introduction of LungFit PH II will play a pivotal role in accelerating our market expansion and advancing our position as a global leader in hospital-based NO delivery.' NO gas is a vasodilator approved in dozens of countries to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents. Low concentration inhaled NO therapy has been the standard-of-care for PPHN for over 20 years in the United States. PPHN is a lethal condition and secondary to failure of normal circulatory transition at birth. It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1,000 live births (0.4-6.8/1,000 live births) with a mortality rate ranging between 4-33%. This syndrome complicates the course of about 10% of infants with respiratory failure and remains a source of considerable morbidity and mortality. In the European Union and many other countries outside the United States, NO is also approved for the treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function. About LungFit *Beyond Air's LungFit is a cylinder-free, phasic flow generator and delivery system designated as a medical device by the U.S. Food and Drug Administration (FDA). The ventilator-compatible version of the device can generate NO from ambient air on demand for delivery to the lungs at concentrations ranging from 1 ppm to 80 ppm. The LungFit system could potentially replace large, high-pressure NO cylinders, providing significant advantages in the hospital setting, including greatly reducing inventory and storage requirements, improving overall safety by eliminating NO2 purging steps, and offering other operational benefits. LungFit can also deliver NO at concentrations at or above 80 ppm for potentially treating severe acute lung infections in the hospital setting (e.g., COVID-19, bronchiolitis) and chronic, refractory lung infections in the home setting (e.g., NTM). With the elimination of cylinders, Beyond Air intends to offer NO treatment in the home setting. *Beyond Air's LungFit PH is approved for commercial use in the United States, European Union, Australia, Thailand and New Zealand. Beyond Air's other LungFit systems are not approved for commercial use and are for investigational use only. Beyond Air is not suggesting NO use over 80 ppm or use at home. About PPHNPersistent pulmonary hypertension of the newborn (PPHN) is a lethal condition and secondary to failure of normal circulatory transition at birth. It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1,000 live births (0.4–6.8/1000 live births) with mortality rate ranging between 4–33%. This syndrome complicates the course of about 10% of infants with respiratory failure and remains a source of considerable morbidity and mortality. NO gas is a vasodilator, is approved in dozens of countries to improve oxygenation and reduces the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents. About Beyond Air®, Air is a commercial-stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. The Company has received FDA approval and CE Mark for its first system, LungFit® PH, for the treatment of term and near-term neonates with hypoxic respiratory failure. Beyond Air is currently advancing its other revolutionary LungFit systems in clinical trials for the treatment of severe lung infections such as viral community-acquired pneumonia (including COVID-19) and nontuberculous mycobacteria (NTM). The Company has also partnered with The Hebrew University of Jerusalem to advance a pre-clinical program dedicated to the treatment of autism spectrum disorder (ASD) and other neurological disorders. Additionally, Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more information, visit Forward Looking StatementsThis press release contains 'forward-looking statements' concerning the potential safety and efficacy of inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate, as well as its therapeutic potential in a number of indications; and the potential impact on patients and anticipated benefits associated with inhaled nitric oxide and the ultra-high concentration nitric oxide product candidate. Forward-looking statements include statements about expectations, beliefs, or intentions regarding product offerings, business, results of operations, strategies or prospects. You can identify such forward-looking statements by the words 'appears,' 'expects,' 'plans,' 'anticipates,' 'believes' 'expects,' 'intends,' 'looks,' 'projects,' 'goal,' 'assumes,' 'targets' and similar expressions and/or the use of future tense or conditional constructions (such as 'will,' 'may,' 'could,' 'should' and the like) and by the fact that these statements do not relate strictly to historical or current matters. Rather, forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause actual results to differ materially from any future results expressed or implied by the forward-looking statements. These forward-looking statements are only predictions and reflect views as of the date they are made with respect to future events and financial performance. Many factors could cause actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including risks related to the ability to raise additional capital; the timing and results of future pre-clinical studies and clinical trials; the potential that regulatory authorities, including the FDA and comparable non-U.S. regulatory authorities, may not grant or may delay approval for our product candidates; the approach to discover and develop novel drugs, which is unproven and may never lead to efficacious or marketable products; the ability to fund and the results of further pre-clinical studies and clinical trials of our product candidates; obtaining, maintaining and protecting intellectual property utilized by products; obtaining regulatory approval for products; competition from others using similar technology and others developing products for similar uses; dependence on collaborators; and other risks, which may, in part, be identified and described in the 'Risk Factors' section of Beyond Air's most recent Annual Report on Form 10-K and other of its filings with the Securities and Exchange Commission, all of which are available on Beyond Air's website. Beyond Air and Beyond Cancer undertake no obligation to update, and have no policy of updating or revising, these forward-looking statements, except as required by applicable law. CONTACTS:Investor Relations contactsCorey Davis, Advisors, LLCCdavis@ 915-2577 A photo accompanying this announcement is available at
