Beyond Air Inc

Beyond Air, Inc. is a clinical-stage medical device and biopharmaceutical company. It engages in developing a nitric oxide generator and delivery system that uses nitric oxide generated from ambient air and delivers precise amounts of nitric oxide to the lungs for the potential treatment of respiratory and other diseases. It operates under the Beyond Air and Beyond Cancer segments. The firm developed the LungFit platform system, a generator and delivery system that produces nitric oxide from ambient air, eliminating the need for expensive and cumbersome cylinders. The company was founded in 2011 and is headquartered in Garden City, NY.

Earnings data Q4 2021

Earnings data Q1 2022

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Earnings data Q4 2022

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XAIR reports successful Q1 launch of LungFit PH, faces revenue challenges

XAIR's Q1 2023 performance reflects initial investment in commercial launch and R&D, with a focus on sustainable growth. The company's successful commercial launch of LungFit PH and plans for expansion demonstrate market potential. However, managing revenue expectations and strategic resource allocation present challenges. Anticipated international market expansion and the potential impact of the autism program offer future opportunities.

Beyond Air reports Q2 earnings, anticipates regulatory progress and challenges

Beyond Air's Q2 earnings call highlighted the commercial progress of LungFit PH, financial results, and strategic plans. The company faces challenges with reimbursement and contract signings but sees opportunities in VCAP trials and regulatory discussions.

XAIR anticipates strong revenue growth and market expansion opportunities

Beyond Air Inc's Q3 2023 performance reflected increased expenses and a GAAP net loss, with a focus on product development and market expansion.
Strengths include positive feedback on LungFit PH, strong leadership, and a dedicated commercial team driving successful launches.
Challenges include regulatory delays, hospital contracting issues, and delays in patient studies, requiring strategic resolutions.
Opportunities lie in team expansion, addressing contracting challenges, FDA meetings, and providing guidance for future growth.
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Beyond Air Inc reports successful product launch and secures funding

Beyond Air Inc's Q4 2023 earnings call highlighted a successful commercial launch of LungFit PH and debt financing to support growth initiatives.
While facing challenges such as $0 revenue and cash usage, the company aims to optimize operations and drive revenue generation.
Opportunities lie in expanding product offerings, enhancing customer service, and leveraging unique programs like the early-stage autism initiative.
Overall, Beyond Air Inc remains focused on driving commercial success and maintaining a strong market position through strategic initiatives.

Beyond Air Inc reports Q1 revenue growth and strategic financing

Beyond Air Inc's Q1 2024 earnings call highlighted revenue generation, increased expenses, and strategic financing. The company faces challenges in study endpoints and FDA agreements but sees opportunities in product expansions and regulatory approvals.

Beyond Air Inc reports Q2 earnings, eyes growth opportunities

Beyond Air Inc's Q2 2024 earnings call highlighted revenue guidance for FY 2025, strategic partnerships, and progress in research and development across multiple therapeutic areas.
The company's commercial success with LungFit PH, FDA approvals, and ongoing studies demonstrate a commitment to innovation and market growth amidst financial challenges.
Challenges in financial performance, market dynamics, and competition underscore the need for continued strategic planning and operational efficiency to drive sustainable profitability.
With a diversified pipeline, upcoming data releases, and product enhancements, Beyond Air Inc is poised to capitalize on growth opportunities and strengthen its position in the market.

Beyond Air Inc reports revenue growth and regulatory milestones ahead

Beyond Air Inc shows promising revenue growth and market acceptance, supported by new contracts and product demand.
While facing financial losses and regulatory uncertainties, the company's focus on innovation and customer relationships positions it well for future success.
Anticipated FDA decisions, ongoing hospital starts, and strong leadership underpin the company's growth potential and strategic outlook.

Beyond Air Q4: Growth Amid Challenges, Revenue Down

Beyond Air Inc. concluded fiscal Q4 2024 with significant developments and challenges. While the company demonstrated strong product usage and customer retention, it faces hurdles in customer acquisition speed and legal issues. Financially, the substantial net loss and revised down revenue projections highlight areas needing attention.

Beyond Air Inc reports growth in hospital clients and global expansion

Beyond Air Inc's Q2 2025 earnings call highlighted significant achievements, including a surge in hospital clients, strategic partnerships for global expansion, and progress on regulatory approvals for key products. The company showcased a commitment to financial sustainability through cash runway extension and cost reduction measures.
While facing challenges such as regulatory approval delays and a reported net loss, Beyond Air Inc remains focused on innovation and market growth. Opportunities lie in leveraging partnerships, product expansions, and cash reserves to drive future revenue and profitability.
Overall, Beyond Air Inc's performance reflects a mix of strengths, challenges, and opportunities, positioning the company for potential growth and market success. Analyst inquiries during the call underscored a keen interest in contract growth, strategic partnerships, and revenue prospects.

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Beyond Air, Inc. is a commercial stage medical device and biopharmaceutical company, which engages in the development of endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. It operates through the Beyond Air and Beyond Cancer segments. The company was founded on April 28, 2015 and is headquartered in Garden City, NY.

GARDEN CITY, N.Y., July 08, 2021 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, today announced that Steve Lisi, Chairman and Chief Executive Officer of Beyond Air, is scheduled to participate in two upcoming virtual investor conferences in July 2021.

Beyond Air® Announces Participation at Upcoming Virtual Investor Conferences in July 2021

Beyond Air (XAIR) has moved higher as of late, but there could definitely be trouble on the horizon for this company

Beyond Air (XAIR) is in Overbought Territory: What's Next?

Beyond Air's (XAIR) CEO Steve Lisi on Q4 2021 Results - Earnings Call Transcript

Submitted first premarket approval (PMA) application in the Company's history to FDA for LungFit ® PH to treat persistent pulmonary hypertension of the newborn (PPHN); Company preparing for commercial launch in the fourth quarter of calendar year 2021

Beyond Air® Reports Financial Results for Fourth Fiscal Quarter and Year-End 2021

GARDEN CITY, N.Y., May 26, 2021 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, today announced an agreement with former LungFit® PH commercial licensee, Circassia Group plc. Under the terms of the agreement, Beyond Air retains United States and China commercialization rights to LungFit® PH in exchange for returning upfront and milestone payments received by the Company in 2019, along with capped future royalty payments. Beyond Air now holds full global rights to LungFit® PH.

Beyond Air® Reaches Settlement Agreement with Circassia for LungFit® PH

Call scheduled for Thursday, June 10th at 4:30 pm Eastern Time Call scheduled for Thursday, June 10th at 4:30 pm Eastern Time

Beyond Air® Schedules Fiscal Year 2021 Financial Results Conference Call and Webcast

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I nterim analysis from the ongoing, open-label, randomized acute viral pneumonia (including COVID-19) pilot study shows 150 ppm nitric oxide (NO) administered with LungFit® PRO is well-tolerated with no treatment-related adverse events, and demonstrates encouraging efficacy signals

Beyond Air® Presents Data in Hospitalized Patients with Viral Lung Infections (including COVID-19) from LungFit® PRO Programs at ATS 2021

Former Director of Healthcare Partnerships and External Relations at Linde plc brings 26 years of experience to Beyond Air Former Director of Healthcare Partnerships and External Relations at Linde plc brings 26 years of experience to Beyond Air

Beyond Air® Appoints Peter Senior as Director of Business Development

GARDEN CITY, N.Y., April 14, 2021 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, today announced that Steve Lisi, Chairman and Chief Executive Officer of Beyond Air, is scheduled to participate in two upcoming virtual investor conferences in May 2021.

Beyond Air® Announces Participation at Upcoming Virtual Investor Conferences in May 2021

Proprietary cylinder-free LungFit system that can produce NO from ambient air, leading to substantial benefits over traditional systems. Close to FDA approval for first product LungFit PH which will likely dominate a TAM of close to $500mil with few competitors.

Beyond Air: Tiny Company With Truly Massive Potential

Award will help fund the development of high concentration nitric oxide (NO) for Nontuberculous Mycobacteria (NTM) pulmonary disease, which disproportionately affects cystic fibrosis (CF) patients

Beyond Air® Receives Grant for Up to $2.17 million from the Cystic Fibrosis Foundation to Advance the Clinical Development of Inhaled Nitric Oxide to Treat Nontuberculous Mycobacteria Pulmonary Disease

Beyond Air's (XAIR) CEO Steve Lisi on Q3 2021 Results - Earnings Call Transcript

Shares of Beyond Air (NASDAQ:XAIR) moved lower in after-market trading after the company reported Q3 results. Quarterly Results Earnings per share were up 23.26% over the past year to ($0.33), which missed the estimate of ($0.31).

Beyond Air: Q3 Earnings Insights

U.S. FDA reviewing premarket approval (PMA) submission for LungFitTM PH to treat persistent pulmonary hypertension of the newborn (PPHN), as Company prepares for commercialization

Beyond Air® Reports Financial Results for Third Quarter of Fiscal Year 2021 and Provides Business Update

Call scheduled for Tuesday, February 9th at 4:30 pm Eastern Time Call scheduled for Tuesday, February 9th at 4:30 pm Eastern Time

Beyond Air® Schedules Third Fiscal Quarter 2021 Financial Results Conference Call and Webcast

Beyond Air Offers Compelling Value Heading Into Its First Potential Product Approval

GARDEN CITY, N.Y., Nov. 19, 2020 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, today announced that Steve Lisi, Chairman and Chief Executive Officer of Beyond Air, will participate in the 32nd Annual Piper Sandler Healthcare Conference being held virtually from December 1-3, 2020. Beyond Air will provide a pre-recorded investor presentation and will be available for virtual one-on-one meetings during the conference.

Beyond Air® to Participate in the 32nd Annual Piper Sandler Healthcare Conference from December 1-3, 2020

Beyond Air, Inc. (XAIR) CEO Steve Lisi on Q2 2021 Results - Earnings Call Transcript

Potential to revolutionize nitric oxide therapy by eliminating need for cumbersome cylinders creating im proved economics and safety in hospital setting

Beyond Air® Submits Premarket Approval Application to FDA for LungFit™ PH to Treat Persistent Pulmonary Hypertension of the Newborn

Call scheduled for Wednesday, November 11th at 4:30 pm Eastern Time Call scheduled for Wednesday, November 11th at 4:30 pm Eastern Time

Beyond Air® Schedules Second Fiscal Quarter 2021 Financial Results Conference Call and Webcast

Patients with pneumonia caused by any virus, including SARS-CoV-2, will be considered for enrollment

Beyond Air® Approved to Initiate Clinical Study at 150 ppm Nitric Oxide with LungFit™ for the Treatment of Acute Viral Pneumonia Including COVID-19

New in vivo data for colon cancer show anti-tumor immunity in 100% of mice

Beyond Air® Presents In Vivo Solid Tumor Data Confirming In Situ Cancer Vaccination with a Single Injection of Gaseous Nitric Oxide at the AACR Conference on Tumor Immunology and Immunotherapy

In vitro data support development of nitric oxide as a potential coronavirus therapy that acts within hours

Beyond Air® Presents Data Showing Anti-Coronavirus Activity of Nitric Oxide at the CHEST Annual Meeting 2020

150 ppm nitric oxide was statistically significant compared to both control and 85 ppm nitric oxide arms on the primary and key secondary endpoints

News for Beyond Air Inc Stock (XAIR)