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

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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.

-- Data show favorable safety, tolerability, and efficacy results -- -- All patients titrated to 250 ppm NO with no patients needing to reduce concentration --

Beyond Air® Announces Positive Data from At-Home Pilot Study in Patients with Refractory NTM Lung Infection Treated with (NO) using the LungFit® GO at the CHEST Annual Meeting 2022

Abstract titles to be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting were released publicly today at 8:00 AM EDT Abstract titles to be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting were released publicly today at 8:00 AM EDT

Beyond Cancer™ to Present Pre-Clinical Data for Ultra-High Concentration Nitric Oxide Therapy at the 2022 SITC Annual Meeting

GARDEN CITY, N.Y., Oct. 03, 2022 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a 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, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced that the Annals of the American Thoracic Society published a detailed review of the Company's third pilot study of inhaled NO in bronchiolitis patients. The publication offers an overview of the study design and previously announced results, as well as the rationale for conducting a pivotal study. The manuscript in the Annals of the American Thoracic Society is available at (https://doi.org/10.1513/AnnalsATS.202103-348OC).

Beyond Air® Announces that Annals of the American Thoracic Society Published a Review of the Third Pilot Study of High Dose Nitric Oxide for Bronchiolitis

GARDEN CITY, N.Y., Sept. 16, 2022 (GLOBE NEWSWIRE) -- Beyond Air, Inc. (NASDAQ: XAIR), a 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, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced that the Company is scheduled to participate in a fireside chat at the LifeSci Partners HealthTech Symposium being held virtually September 20-21, 2022. Additionally, Steve Lisi, Chairman and CEO of Beyond Air, will be presenting corporate overviews and participating in 1x1 meetings at the Ladenburg Thalmann Healthcare Conference being held Thursday, September 29, 2022 at the Sofitel Hotel New York and the Roth Inaugural Healthcare Opportunities Conference on October 6, 2022 in New York City.

Beyond Air® To Participate in Three Upcoming Investor Conferences

GARDEN CITY, N.Y. and HAMILTON, Bermuda, Aug. 23, 2022 (GLOBE NEWSWIRE) -- Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. (NASDAQ: XAIR) that is focused on developing ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced that the first patient was treated in a first-in-human Phase 1 study to assess the safety and immune biomarkers of UNO therapy.

Beyond Air® Affiliate Beyond Cancer™ Doses Initial Patient in First-in-Human Phase 1 Study of Ultra-High Concentration Nitric Oxide Therapy at Tel Aviv Sourasky Medical Center (Ichilov)

Beyond Air, Inc. (NASDAQ:XAIR ) Q1 2023 Results Earnings Conference Call August 11, 2022 4:30 PM ET Company Participants Corey Davis - Investor Relations, LifeSci Advisors Steve Lisi - Chairman and Chief Executive Officer Duncan Fatkin - Chief Commercial Officer Douglas Larson - Chief Financial Officer Conference Call Participants Greg Fraser - Truist Securities Scott Henry - ROTH Capital Partners, LLC Matt Kaplan - Ladenburg Thalmann Yale Jen - Laidlaw & Company Kalia - Oppenheimer Operator Good afternoon. And welcome, everyone, to the Beyond Air financial results conference call for the first fiscal quarter ended June 30, 2022.

Beyond Air, Inc. (XAIR) CEO Steve Lisi on Q1 2023 Results - Earnings Call Transcript

Call scheduled for Thursday, August 11th at 4:30 pm Eastern Time Call scheduled for Thursday, August 11th at 4:30 pm Eastern Time

Beyond Air® Schedules First Fiscal Quarter 2023 Financial Results Conference Call and Webcast

XAIR stock is jumping nearly 20% and is trending on many social media websites. The company's LungFit PH device was approved by the FDA.

Beyond Air (XAIR) Stock Gains Almost 20% on FDA Approval

The FDA has approved Beyond Air Inc's (NASDAQ: XAIR) LungFit PH to treat term and near-term neonates with hypoxic respiratory failure (often referred to as persistent pulmonary hypertension of the newborn or PPHN).  LungFit PH is the initial device from the LungFit.

Beyond Air Scores First FDA Approval For LungFit PH In Respiratory Failure

Beyond Air, Inc. (NASDAQ:XAIR ) Q4 2022 Earnings Conference Call June 28, 2022 4:30 PM ET Company Participants Corey Davis - Investor Relations Steve Lisi - Chairman and Chief Executive Officer Duncan Fatkin - Chief Commercial Officer Douglas Larson - Chief Financial Officer Conference Call Participants Matt Kaplan - Ladenburg Thalmann Suraj Kalia - Oppenheimer Greg Fraser - Truist Securities Yale Jen - Laidlaw & Company Operator Good afternoon and welcome to the Beyond Air Fiscal Year 2022 Financial Results and LungFit PH Approval Conference Call. [Operator Instructions] And now I would like to turn the call over to Corey Davis from LifeSci Advisors.

Beyond Air, Inc. (XAIR) CEO Steve Lisi on Q4 2022 Results - Earnings Call Transcript

LungFit® PH received FDA approval for the treatment of term and near-term neonates with hypoxic respiratory failure on June 28, 2022 and the first phase of U.S. commercial launch has begun

Beyond Air® Reports Financial Results for Fourth Fiscal Quarter and Year-End 2022

First and only nitric oxide generator and delivery system indicated for the treatment of term and near-term neonates with hypoxic respiratory failure that uses ambient air to provide  unlimited, on-demand nitric oxide

Beyond Air's LungFit® PH Receives FDA Approval to Treat Term and Near-Term Neonates with Hypoxic Respiratory Failure

GARDEN CITY, New York, June 14, 2022 (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, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced that it has rescheduled the reporting of the financial results for its fiscal fourth quarter and year ended March 31, 2022 to Tuesday, June 28, 2022. The Company's management team will also host its quarterly conference call and webcast at 4:30 pm Eastern Time on June 28th.

Beyond Air® Announces Fiscal Year End 2022 Financial Results Conference Call and Webcast Moved to Tuesday, June 28th

Dr. Monson is a board-certified radiation oncologist and brings over 25 years of clinical oncology experience to Beyond Cancer.

Beyond Cancer™ Announces the Appointment of Jedidiah Monson, M.D. to Chief Medical Officer

Ms. Jones brings over 30 years of life science based financial experience to Beyond Cancer Ms. Jones brings over 30 years of life science based financial experience to Beyond Cancer

Beyond Cancer, Ltd. Appoints Susan Howell Jones, CPA as Chief Financial Officer

Call scheduled for Thursday, June 16th at 4:30 pm Eastern Time Call scheduled for Thursday, June 16th at 4:30 pm Eastern Time

Beyond Air® Schedules Fiscal Year 2022 Financial Results Conference Call and Webcast

GARDEN CITY, N.Y., April 25, 2022 (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, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced positive long-term safety data for high concentration inhaled NO for the treatment of bronchiolitis. These data were included in an oral presentation at the Pediatric Academic Societies 2022 Meeting (PAS 2022), which is being held April 21-25 in Denver, Colorado.

Beyond Air® Reports Positive Long-Term Safety Data for High Concentration Inhaled Nitric Oxide in Bronchiolitis at the Pediatric Academic Societies Meeting 2022

Inhaled NO treatment in patients hospitalized with COVID-19 and other community-acquired viral pneumonia was well tolerated overall, and safe, with improved efficacy parameters as compared to standard supportive treatment

Beyond Air® Presents Positive Safety and Efficacy Data for Inhaled Nitric Oxide to Treat COVID-19 at ECCMID 2022

GARDEN CITY, N.Y., April 18, 2022 (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, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, today announced that the Company is scheduled to present new data at three upcoming medical conferences.

Beyond Air® to Participate in Three Upcoming Medical Conferences

Data suggests ultra-high concentration gaseous NO (gNO) induced both innate and adaptive immune cell populations, and a decline in immune suppressor cells, which are indicative of an anti-tumor immune response

Beyond Cancer™ Announces New Preclinical Data Presented at American Association for Cancer Research (AACR) Showing Ultra-High Concentration Nitric Oxide Therapy Anti-Tumor Effect

Abstracts for the American Association for Cancer Research (AACR) Annual Meeting were released publicly today at 4:30 PM ET Abstracts for the American Association for Cancer Research (AACR) Annual Meeting were released publicly today at 4:30 PM ET

Beyond Cancer™ to Present Two Abstracts for Ultra-High Concentration Nitric Oxide Therapy at the 2022 AACR Annual Meeting

Beyond Air, Inc.'s (XAIR) CEO Steve Lisi on Q3 2022 Results - Earnings Call Transcript

LungFit® PH premarket approval (PMA) submission under active review by U.S. FDA; approval and commercial launch anticipated in the first half of calendar year 2022 along with European CE Mark

Beyond Air® Reports Financial Results for the Third Quarter of Fiscal Year 2022

GARDEN CITY, N.Y., Feb. 08, 2022 (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, through its affiliate Beyond Cancer, ultra-high concentration nitric oxide (UNO) 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 investor conferences in March 2022.

Beyond Air® Announces Participation at Upcoming Investor Conferences in March 2022

Mr. David Dvorak, previously the President and CEO of Zimmer Biomet, brings a 25+ year proven track record of executive leadership, operating experience, and board memberships

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