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.

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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.

Beyond Air, Inc. (NASDAQ:XAIR ) Q4 2024 Earnings Call Transcript June 24, 2024 4:30 PM ET Company Participants Garth Russell - Investor Relations, LifeSci Advisors Steve Lisi - Chairman and Chief Executive Officer Douglas Larson - Chief Financial Officer Conference Call Participants Marie Thibault - BTIG Yale Jen - Laidlaw & Company Matt Kaplan - Ladenburg Thalmann Operator Good afternoon, and welcome, everyone to the Beyond Air Financial Results Call for the Fiscal Quarter Ended March 31, 2024. At this time, participants are in a listen-only mode.

Beyond Air, Inc. (XAIR) Q4 2024 Earnings Call Transcript

Appointed industry veteran, David Webster, as new Chief Commercial Officer Recently upgraded LungFit PH device expands customer base; revenue growth expected to accelerate each quarter going forward FY 2025 revenue guidance revised to greater than $10 million Implemented capital conservation strategy to reduce cash burn Conference call scheduled for 4:30 p.m. ET today, June 24 th GARDEN CITY, N.Y.

Beyond Air® Reports Fiscal Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update

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Mr. Webster brings more than 20 years of executive level experience in the life sciences industry Mr. Webster brings more than 20 years of executive level experience in the life sciences industry

Beyond Air® Appoints David Webster as Chief Commercial Officer

– Ongoing Phase 1a first-in-human clinical trial continues to demonstrate proof of concept for the UNO solid tumor platform with observed early tumor responses and clinical resolution of radiation dermatitis

Beyond Cancer Presents First-in-Class Clinical Data Showing an Immunogenic Response in Subjects with r/r Unresectable Solid Tumors Treated with Ultra-High Concentration Nitric Oxide (UNO)

GARDEN CITY, N.Y., May 23, 2024 (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 endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate Beyond Cancer, Ltd.

Beyond Air® Schedules Fiscal Year End 2024 Financial Results Conference Call and Webcast

Beyond Air (XAIR) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

Beyond Air (XAIR) Upgraded to Buy: What Does It Mean for the Stock?

GARDEN CITY, N.Y., March 20, 2024 (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 endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate Beyond Cancer, Ltd. (“Beyond Cancer”)), today announced that it has entered into a securities purchase agreement with healthcare focused institutional investors and accredited investors, including certain directors and officers of the Company, whereby the investors have agreed to purchase 9,638,556 shares of the Company's common stock and warrants to purchase up to an aggregate of 9,638,556 shares of common stock at a purchase price of $1.66 per share and accompanying warrant in a registered direct offering priced at-the-market under Nasdaq rules. The warrants have an exercise price of $2.25 per share, will be exercisable immediately upon issuance and will have a term of three years following the date of issuance. The Company can call the warrants if it reports equal to or greater than $4.5 million of net sales for the quarter ending March 31, 2025 which will require exercise within 10 business days. The closing of the offering is expected to occur on or about March 22, 2024, subject to the satisfaction of customary closing conditions.

Beyond Air® Announces Pricing of $16.0 Million Registered Direct Offering of Common Stock and Warrants

Beyond Air, Inc. (XAIR) Q3 2024 Earnings Call Transcript

Beyond Air, Inc. (XAIR) came out with a quarterly loss of $0.50 per share versus the Zacks Consensus Estimate of a loss of $0.61. This compares to loss of $0.43 per share a year ago.

Beyond Air, Inc. (XAIR) Reports Q3 Loss, Misses Revenue Estimates

Commercial demand for LungFit® PH increasing; manufacturing of upgraded devices is ramping up to meet growing demand

Beyond Air® Reports Financial Results for Third Quarter of Fiscal Year 2024

GARDEN CITY, N.Y., Jan. 18, 2024 (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 endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate Beyond Cancer, Ltd.

Beyond Air® Schedules Third Fiscal Quarter 2024 Financial Results Conference Call and Webcast

No dose limiting toxicities were reported in the first cohort of ultra-high concentration of nitric oxide administered at 25,000 parts per million (PPM)

Beyond Cancer™ Phase 1 Study Clears Cohort 1 in Patients with Advanced Relapsed or Refractory Unresectable Primary or Metastatic Cutaneous or Subcutaneous Solid Tumors

GARDEN CITY, N.Y., Nov. 15, 2023 (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 endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate Beyond Cancer, Ltd. (“Beyond Cancer”)), today announced that Steve Lisi, Chairman and Chief Executive Officer of Beyond Air, will participate in a fireside discussion and one-on-one meetings at the Piper Sandler Healthcare Conference being held November 28-30, 2023 in New York City.

Beyond Air® To Participate in the 35th Annual Piper Sandler Healthcare Conference

Beyond Air, Inc. (NASDAQ:XAIR ) Q2 2024 Earnings Conference Call November 13, 2023 4:30 PM ET Company Participants Edward Barger - Head of Investor Relations Steve Lisi - Chairman and Chief Executive Officer Duncan Fatkin - Chief Commercial Officer Douglas Larson - Chief Financial Officer Conference Call Participants Jeremy Jacoby - Truist Securities Marie Thibault - BTIG Matt Kaplan - Ladenburg Thalmann Operator Good afternoon and welcome everyone to the Beyond Air Financial Results Call for the Fiscal Quarter ended September 30, 2023. At this time, participants are in a listen-only mode.

Beyond Air, Inc. (XAIR) Q2 2024 Earnings Call Transcript

Provides fiscal year 2025 revenue guidance of $12 - $16 million US pilot trial of LungFit® PRO to treat viral community acquired pneumonia (VCAP) underway with data expected mid-calendar 2024 Beyond Cancer presents positive first-in-human data for intratumoral administration of ultra-high concentration nitric oxide (UNO) therapy demonstrating safety and evidence of immune system activation at the Society for Immunotherapy Conference (SITC) Submitted PMA supplement to FDA for the expansion of LungFit PH label to include cardiac surgery; approval anticipated in second half calendar 2024 LungFit PH granted Innovative Technology contract from  Vizient, Inc. , the nation's largest provider-driven health care performance improvement company Entered into an agreement with Getz Healthcare to commercialize the LungFit PH device in certain countries across the Asia-Pacific region Conference call scheduled for 4:30 p.m. ET today, November 13 t h GARDEN CITY, N.Y.

Beyond Air® Reports Financial Results for Second Quarter of Fiscal Year 2024

First-in-human Phase 1 study demonstrates early clinical proof of concept Positive clinical biomarker data demonstrate evidence of immune system activation and the translation of the immunogenic response previously observed in preclinical studies Data represent the first successful administration of intratumoral UNO therapy Additional Phase 1 data for UNO expected in 2024 GARDEN CITY, N.Y. and HAMILTON, Bermuda, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Beyond Cancer, Ltd.

Beyond Cancer™ Presents Positive First-in-Human Clinical Data for Ultra-High Concentration Nitric Oxide (UNO) Therapy in Solid Tumors During the Society for Immunotherapy of Cancer (SITC) 2023 Annual Meeting

GARDEN CITY, N.Y., Oct. 19, 2023 (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 endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate Beyond Cancer, Ltd.

Beyond Air® Schedules Second Fiscal Quarter 2024 Financial Results Conference Call and Webcast

GARDEN CITY, N.Y., Oct. 17, 2023 (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 endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate Beyond Cancer, Ltd. (“Beyond Cancer”)), today announced that Steve Lisi, Chairman and Chief Executive Officer of Beyond Air, will provide a corporate presentation and participate in one-on-one meetings at the Truist Securities BioPharma Symposium being held on Wednesday, November 8, 2023 in New York, NY.

Beyond Air® To Participate in the Truist Securities BioPharma Symposium

UNO therapy results in a more immunogenic tumor microenvironment (TME) as well as a systemic response that overcomes anti-PD-1 resistance

Beyond Cancer™ Publishes Pre-Clinical Data in Cells Demonstrating that the Combination of Ultra-High Concentration Nitric Oxide (UNO) and Anti-mPD-1 Therapy Improves Tumor Regression Rates and Survival in Mice

50,000 or 100,000 ppm UNO alone or in combination with anti-mCTLA-4 more than tripled antigen specific central memory T-cell response versus anti-mCTLA-4 alone

Beyond Cancer™ Presents Positive Preclinical Data for Ultra-High Concentration Nitric Oxide (UNO) in Combination with Checkpoint Inhibitor Therapy During the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

Contract awarded for products that bring improvement to health care industry Contract awarded for products that bring improvement to health care industry

Beyond Air® Receives Innovative Technology Contract from Vizient for LungFit®PH

GARDEN CITY, N.Y. and HAMILTON, Bermuda, Oct. 04, 2023 (GLOBE NEWSWIRE) -- Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc. (NASDAQ: XAIR) that is developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors, today announced that Beyond Cancer, Ltd. will present two proffered posters at the upcoming American Association for Cancer Research-National Cancer Institute-European Organisation for Research and Treatment of Cancer (AACR-NCI-EORTC) International Conference on Molecular Targets and Cancer Therapeutics 2023, which is scheduled to be held October 11th – 15th in Boston, Massachusetts. Abstracts are scheduled to be released to AACR-NCI-EORTC registrants today 12:00 pm U.S. ET.

Beyond Cancer™ Selected to Present Proffered Posters Discussing Data from the UNO Therapy Program at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

GARDEN CITY, N.Y., Oct. 02, 2023 (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 endogenous and exogenous nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors (through its affiliate Beyond Cancer, Ltd.), today announced that the Company will present a corporate overview and participate in one-on-one meetings at the Roth MKM 2023 Healthcare Opportunities Conference being held on Thursday, October 12, 2023 in New York City, NY.

Beyond Air® To Participate in the Roth MKM 2023 Healthcare Opportunities Conference

Abstract titles to be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting were released publicly today at 9:00 a.m. EDT Abstract titles to be presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting were released publicly today at 9:00 a.m. EDT

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