Beyond Air News
126 articles
Beyond Air Schedules Second Fiscal Quarter 2026 Financial Results Conference Call and Webcast
Beyond Air, Inc., a commercial-stage medical device and biopharmaceutical company, announced it will report financial results for its second fiscal quarter on November 10, 2025. The company has received FDA approval and CE Mark for its LungFit® PH system, used to treat neonates with hypoxic respiratory failure. Beyond Air is advancing other LungFit systems in clinical trials for severe lung infections and has partnered with The Hebrew University of Jerusalem to explore treatments for autism spectrum disorder. An affiliate, Beyond Cancer, Ltd., is investigating nitric oxide delivery for solid tumors. The companys focus on nitric oxide technology positions it for growth in treating respiratory and neurological conditions.
FDA approvedPartnersProduct Stage
Beyond Air to Participate in the ROTH 4th Annual Healthcare Opportunities Conference
Beyond Air, Inc., a commercial-stage medical device and biopharmaceutical company, announced its participation in the ROTH 4th Annual Healthcare Opportunities Conference. The company focuses on harnessing nitric oxide to treat respiratory illnesses, neurological disorders, and solid tumors. Beyond Air has received FDA approval and CE Mark for its LungFit® PH system for treating neonates with hypoxic respiratory failure. The company is advancing other LungFit systems in clinical trials for severe lung infections and has partnered with The Hebrew University of Jerusalem for a pre-clinical program targeting autism spectrum disorder. Beyond Cancer, Ltd., an affiliate, is investigating NO for solid tumors. The companys innovations aim to improve safety and operational efficiency in medical settings.
Product StagePartnersFDA approved/pending approval
BC-Most Active Stocks
The article provides a list of the most active stocks on the Nasdaq, NYSE, and NYSE American exchanges, highlighting their trading volumes, high and low prices, last traded prices, and price changes. Opendoor Technologies Inc. is one of the companies mentioned, with a significant trading volume of 480,513,443 shares and a negative price change of -0.61, indicating a growth-negative impact. The article focuses on stock performance and market activity, without discussing specific partnerships, investments, or acquisitions. The data reflects the current market sentiment and trading dynamics for these companies.
Top Midday Gainers
Eightco Holdings announced a private placement of 171.2 million shares priced at $1.46 each. This move is part of a strategic effort to raise capital, indicating a growth-positive impact on the company. The private placement suggests that Eightco Holdings is leveraging financial markets to bolster its financial position. The article does not mention any specific investors involved in this transaction. The company is in the released product stage, and there is no indication of AI technology development or FDA approval. The event reflects a positive financial maneuver for Eightco Holdings.
PIPE
Beyond Air Announces Exercise of Warrants for $3.25 Million of Gross Proceeds
Beyond Air, a commercial stage medical device and biopharmaceutical company, announced a definitive agreement for the immediate exercise of certain outstanding common warrants. This exercise will result in gross proceeds of approximately $3.25 million. Laidlaw & Company (UK) Ltd. is acting as the exclusive placement agent for this offering. The company will issue new unregistered warrants as part of the transaction. The proceeds will be used to advance clinical and pre-clinical programs and for operating expenses. The offering is expected to close on September 9, 2025, subject to customary conditions. The new warrants are offered in a private placement and are not registered under the Securities Act.
PIPE/PO
NeuroNOS Granted FDA Orphan Drug Designation for Glioblastoma, the Most Common and Deadliest Primary Malignant Brain Cancer in Adults
NeuroNOS, a subsidiary of Beyond Air, has received Orphan Drug Designation (ODD) from the FDA for its investigational therapy, BA-101, aimed at treating Glioblastoma (GBM). GBM is a severe brain tumor with limited treatment options. The ODD provides incentives like tax credits and market exclusivity for seven years upon approval. NeuroNOS is focused on developing therapies for rare neurological conditions and is entering the oncology field. The company believes that its nitric oxide inhibition strategy could significantly improve patient outcomes. The FDAs designation is a positive step towards advancing BA-101 into clinical trials.
Product Stage
Beyond Air to Participate in the H.C. Wainwright 27th Annual Global Investment Conference
Beyond Air, Inc., a commercial-stage medical device and biopharmaceutical company, announced its participation in the H.C. Wainwright 27th Annual Global Investment Conference. The company focuses on harnessing nitric oxide to treat respiratory illnesses, neurological disorders, and solid tumors. Beyond Air has received FDA approval and CE Mark for its LungFit® PH system for treating neonates with hypoxic respiratory failure. The company is advancing other LungFit systems in clinical trials for severe lung infections. Beyond Air has partnered with The Hebrew University of Jerusalem to develop treatments for autism spectrum disorder and other neurological disorders. Beyond Cancer, Ltd., an affiliate, is exploring high concentrations of nitric oxide for targeting solid tumors.
FDA approved/pending approvalPartners
Astera Labs Among 3 Leading Growth Companies With Strong Insider Ownership
Astera Labs, a company specializing in semiconductor-based connectivity solutions for cloud and AI infrastructure, is experiencing significant growth. With a market cap of $28.95 billion, the company has shown robust financial performance, with earnings expected to grow at 37.07% annually over the next three years. Recent Q2 2025 results highlighted impressive sales and net income, marking a turnaround from previous losses. Despite being removed from several Russell indexes, Astera Labs strategic partnership with Alchip Technologies is set to enhance its growth potential in the AI infrastructure sector. However, there are concerns that its share price might be overly optimistic.
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Beyond Air Signs New International LungFit PH® Distribution Agreements, Most Notably in Japan
Beyond Air, a commercial-stage medical device and biopharmaceutical company, has expanded its global LungFit PH distribution network by signing new agreements in Japan, South Korea, Costa Rica, Guatemala, Panama, and El Salvador. This expansion brings the companys international coverage to 34 countries, with a combined population of 2.7 billion people. The distribution partner in Japan is AMCO Incorporated, a leading distributor of medical devices. The LungFit PH device generates nitric oxide from ambient air, eliminating the need for traditional high-pressure cylinders, thereby streamlining hospital operations and reducing environmental impact. The company is well-positioned to capture opportunities in both developed and emerging healthcare markets, with hospital tender submissions underway and regulatory approvals pending in several regions.
PartnersProduct Stage
Beyond Air Inc (XAIR) Q1 2026 Earnings Call Highlights: Revenue Surge and Strategic Expansion ...
Beyond Air Inc reported a significant 157% increase in revenue for the first fiscal quarter of 2026, reaching $1.8 million. The company has successfully reduced operating expenses and expanded its distribution network to over 30 countries. Despite a net loss of $7.7 million, this is an improvement from the previous years loss. The company is in the early stages of international expansion, with revenues currently from sales to distribution partners for training and demonstration. The introduction of the second-generation Lungfit system is anticipated to impact market share significantly, though FDA approval timing remains uncertain. The company needs to secure more contracts to meet its revenue guidance for fiscal year 2026.
CustomersPartnersProduct Stage
Beyond Air® Reports Fiscal First Quarter 2026 Financial Results and Provides Corporate Update
Beyond Air, a commercial stage medical device and biopharmaceutical company, reported a 157% increase in revenues to $1.8 million for the fiscal quarter ended June 30, 2025. The growth was driven by increased demand for their LungFit PH system, supported by new distribution agreements across Europe, the Middle East, and Asia, and a national group purchasing agreement with Premier, Inc. Beyond Air reaffirmed its revenue guidance of $12-$16 million for fiscal year 2026. The company is also advancing its Beyond Cancer program, focusing on clinical stage development of ultra-high concentration nitric oxide technology for solid tumors. A PMA supplement for the second-generation LungFit PH was submitted to the FDA in June 2025.
CustomersPartnersProduct Stage
Beyond Air, Inc. (XAIR) Reports Q1 Loss, Lags Revenue Estimates
Beyond Air, Inc. reported a quarterly loss of $1.53 per share, slightly below the Zacks Consensus Estimate of a $1.5 loss. This marks an earnings surprise of -2.00%. The company posted revenues of $1.76 million, missing the consensus estimate by 1.68%. Despite surpassing consensus EPS estimates three times in the last four quarters, Beyond Air shares have declined by about 55.9% since the start of the year, underperforming the S&P 500s gain of 8.4%. The companys earnings outlook remains crucial for its stocks future performance, with a current Zacks Rank of #2 (Buy), indicating potential market outperformance in the near future.
AbCellera Biologics Inc. (ABCL) Reports Q2 Loss, Beats Revenue Estimates
AbCellera Biologics Inc. reported a quarterly loss of $0.12 per share, beating the Zacks Consensus Estimate of a $0.17 loss, marking an earnings surprise of +29.41%. The company also reported revenues of $17.08 million, surpassing the consensus estimate by 146.95%. Over the last four quarters, AbCellera has exceeded EPS estimates three times. The companys stock has risen by about 40.6% since the beginning of the year, outperforming the S&P 500s gain of 7.9%. The sustainability of this growth will depend on future earnings expectations and managements commentary. The current Zacks Rank for the stock is #3 (Hold), indicating it is expected to perform in line with the market.
Beyond Air Schedules First Fiscal Quarter 2026 Financial Results Conference Call and Webcast
Beyond Air, a commercial-stage medical device and biopharmaceutical company, announced it will report its financial results for the first fiscal quarter on August 12, 2025. The company focuses on using nitric oxide to treat respiratory illnesses, neurological disorders, and solid tumors. Beyond Air has received FDA approval and CE Mark for its LungFit PH system for treating neonatal hypoxic respiratory failure. The company is advancing other LungFit systems in clinical trials for severe lung infections. Beyond Air has partnered with The Hebrew University of Jerusalem to explore treatments for autism spectrum disorder and other neurological disorders. Beyond Cancer, an affiliate, is researching high concentrations of nitric oxide for solid tumors. The article highlights the companys growth and ongoing projects.
Product StagePartnersFDA approved/pending approval
Beyond Air Awarded Therapeutic Gases Agreement with Premier, Inc.
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, has secured a national group purchasing agreement with Premier, Inc. for its LungFit PH system and NO2 Smart Filters. This agreement, effective from July 15, 2025, allows Premier members to access special pricing and terms, facilitating the adoption of Beyond Airs innovative cylinder-free nitric oxide delivery system across Premiers extensive network of U.S. hospitals and healthcare providers. The LungFit PH system, which uses patented Ionizer technology, offers a transformative advancement in nitric oxide delivery, ensuring safe and efficient treatment for ventilated patients. This partnership is expected to streamline the sales process and expand the reach of Beyond Airs products in the healthcare sector.
Partners
Here's Why Beyond Air (XAIR) Could be Great Choice for a Bottom Fisher
Beyond Air, Inc. (XAIR) has experienced a recent downtrend, with its stock losing 13.7% over the past week. However, a hammer chart pattern formed in the last trading session suggests a potential trend reversal, indicating that the stock may have found support. Wall Street analysts have shown rising optimism about the companys future earnings, with the consensus EPS estimate for the current year increasing by 40.5% over the last 30 days. This upward trend in earnings estimate revisions is a bullish indicator, suggesting that Beyond Air, Inc. may report better earnings than previously predicted.
Beyond Air Full Year 2025 Earnings: EPS Beats Expectations, Revenues Lag
Beyond Air reported a significant increase in revenue, up 220% from the previous fiscal year, reaching US$3.71 million. The companys net loss narrowed by 23% to US$46.6 million, and the loss per share improved from US$1.82 to US$0.63. Despite missing revenue estimates by 5.5%, Beyond Air exceeded earnings per share expectations by 7.0%. The company is expected to grow its revenue by 38% annually over the next three years, outperforming the US Medical Equipment industrys forecasted growth of 8.1%. The companys shares have risen by 1.2% over the past week.
Beyond Air Inc (XAIR) (Q4 2025) Earnings Call Highlights: Revenue Soars Amidst Strategic Global ...
Beyond Air Inc reported a significant 220% increase in revenue for the fiscal year ending March 31, 2025, reaching $3.7 million. The company has set a revenue guidance of $12 million to $16 million for the next fiscal year, indicating strong growth expectations. Despite the revenue growth, the company faced a net loss of $46.6 million, primarily due to high costs associated with the LungFit devices and R&D expenses. Beyond Air has expanded its customer base in the US and internationally, securing distribution agreements in over two dozen countries. The companys subsidiary, NeuroNOS, received Orphan Drug Designation from the FDA for its investigational therapy, BA-102. However, the company faces challenges with regulatory hurdles and is awaiting FDA approval for its second-generation LungFit PH II system.
CustomersPartnersFDA approved/pending approval
Beyond Air® Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
Beyond Air, Inc., a commercial-stage medical device and biopharmaceutical company, reported a 220% increase in revenue for the fiscal year ending March 31, 2025, reaching $3.7 million. The company anticipates at least $1.7 million in revenue for the quarter ending June 30, 2025, and projects fiscal year 2026 revenue between $12 and $16 million. Beyond Air has submitted a PMA supplement for its second-generation LungFit PH device to the FDA, which could significantly impact its market potential. The company has expanded its international distribution partnerships, covering over 2 billion lives across Europe, the Middle East, and Asia. Additionally, Robert Goodman has been appointed to the Board of Directors. The company is actively shipping LungFit PH to multiple regions and has established a partnership with Vanderbilt University Medical Center.
CustomersPartnersManagement ChangesProduct Stage
Beyond Air Submits FDA PMA Supplement for Next Generation LungFit® PH
Beyond Air, Inc., a medical device and biopharmaceutical company, has announced the submission of a premarket approval (PMA) supplement application to the FDA for its LungFit PH II system. This next-generation nitric oxide generator is designed to be smaller, lighter, and transport-ready, offering significant improvements over the first-generation device. The LungFit PH II system is expected to enhance the companys market position by providing a superior alternative to existing systems, with features like reduced weight, simplified operation, and compatibility with both air and ground transport. The system uses patented Ionizer™ technology to generate nitric oxide from ambient air, ensuring minimal disruption for existing customers. Once approved, the LungFit PH II is anticipated to accelerate market expansion and solidify Beyond Airs leadership in hospital-based NO delivery.
Product StageFDA approved/pending approval
Beyond Air Schedules Fiscal Year End 2025 Financial Results Conference Call and Webcast
Beyond Air, a commercial-stage medical device and biopharmaceutical company, announced it will report its fiscal fourth quarter and full-year financial results on June 17, 2025. The company focuses on using nitric oxide to treat respiratory illnesses, neurological disorders, and solid tumors. Beyond Air has received FDA approval and CE Mark for its LungFit® PH system for treating neonates with hypoxic respiratory failure. The company is advancing other LungFit systems in clinical trials for severe lung infections. Beyond Air has partnered with The Hebrew University of Jerusalem to develop treatments for autism spectrum disorder and other neurological disorders. Beyond Cancer, an affiliate, is exploring ultra-high concentrations of nitric oxide for solid tumors in pre-clinical settings.
Product StageFDA approved/pending approvalPartners
Beyond Air Granted U.S. Patent Covering Treatment of NTM Infections Using gaseous Nitric Oxide (gNO)
Beyond Air, Inc., a commercial-stage medical device and biopharmaceutical company, announced the issuance of a new U.S. patent for its method of delivering gaseous nitric oxide (gNO) to treat non-tuberculous mycobacteria (NTM) lung infections. This patent strengthens Beyond Airs intellectual property portfolio and supports the potential of its LungFit program. The company has published positive clinical data demonstrating the effectiveness of LungFit GO in treating NTM lung infections. Beyond Air has received FDA approval and CE Mark for its LungFit PH system for treating neonates with hypoxic respiratory failure and is advancing other LungFit systems in clinical trials for severe lung infections.
Product StageFDA approved/pending approval
NeuroNOS Granted FDA Orphan Drug Designation for Phelan-McDermid Syndrome, a Neurodevelopmental Disorder Linked to Autism
NeuroNOS, a subsidiary of Beyond Air, has received Orphan Drug Designation (ODD) from the FDA for its investigational therapy, BA-102, aimed at treating Phelan-McDermid Syndrome (PMS), a condition associated with Autism Spectrum Disorder (ASD). This designation is a significant milestone, offering incentives like market exclusivity, tax credits, and fee waivers. The company plans to initiate first-in-human clinical trials in the U.S. by 2026. PMS is a rare genetic disorder with no current FDA-approved treatments, characterized by intellectual disability and autism spectrum behaviors. NeuroNOS aims to address the genetic causes of PMS, providing new treatment options for this unmet medical need.
Product StageFDA approved/pending approval
NeuroNOS Appoints Nobel Prize Laureate, Professor Dan Shechtman, to Scientific Advisory Board
NeuroNOS, a subsidiary of Beyond Air, has appointed Nobel Prize laureate Professor Dan Shechtman to its Scientific Advisory Board. This strategic addition aims to enhance the companys capabilities in developing treatments for Autism Spectrum Disorder (ASD) and Alzheimers Disease (AD). NeuroNOS is focused on pioneering transformative treatments for complex neurological disorders, utilizing a proprietary platform that integrates advanced AI and multidisciplinary tools. The company is currently conducting preclinical studies and plans to initiate first-in-human clinical trials for ASD in 2026. The involvement of two Nobel laureates underscores NeuroNOSs commitment to innovation in neuropsychiatry and neurodegenerative diseases.
Product StageManagement Changes
Beyond Air Publishes Article in Annals of the American Thoracic Society Journal Highlighting NTM-PD Patients’ Ability to Safely Self-Administer High-Dose Intermittent iNO Treatments Using the LungFit™ GO at Home
Beyond Air, a commercial-stage medical device and biopharmaceutical company, announced the publication of a scientific article on a pilot study assessing the use of intermittent inhaled nitric oxide (iNO) for treating nontuberculous mycobacterial (NTM) lung infections. The study, published in the Annals of the American Thoracic Society, revealed high compliance and a favorable safety profile, suggesting potential quality of life improvements and decreased mycobacterial load. Conducted in Australia, the LungFit GO NTM Trial involved a 12-week, multi-center, open-label clinical trial supported by the U.S. Cystic Fibrosis Foundation. The trial demonstrated clinical benefits and safety, supporting further evaluation of inhaled NO delivered using LungFit GO for treating NTM infections.
Product Stage
NeuroNOS Announces Groundbreaking Research Publication by its CSO Demonstrating Mechanism of Action in Alzheimer’s Disease and Reinforcing Platform’s Strength Across Neurological Disorders
NeuroNOS, a subsidiary of Beyond Air, has announced a significant breakthrough in Alzheimers disease research. The companys Chief Scientific Officer, Prof. Haitham Amal, published a study in Translational Psychiatry revealing a novel mechanism in the early stages of Alzheimers disease. The research identifies disruptions in nitric oxide-related pathways, suggesting that targeted inhibition of NO production could be a promising therapeutic strategy. NeuroNOS is in advanced stages of formulation development and manufacturing, preparing for clinical trials. This development is seen as a positive step towards addressing the urgent need for effective treatments for neurodegenerative disorders.
Product Stage
Beyond Air Announces Vanderbilt University Medical Center as First Luminary Site
Beyond Air, a commercial-stage medical device and biopharmaceutical company, has announced a partnership with Vanderbilt University Medical Center (VUMC) as its first luminary site. This collaboration aims to evaluate and showcase the clinical and operational benefits of Beyond Airs LungFit PH, a tankless nitric oxide delivery system. The partnership is expected to enhance awareness and adoption of this innovative technology in respiratory care. VUMCs involvement will help optimize LungFit products and explore new opportunities for hospital-based nitric oxide therapy. The collaboration marks a significant milestone for Beyond Air in redefining iNO delivery and driving innovation in the field.
Partners
NeuroNOS Secures $2.0 Million in Funding to Advance Development of an Innovative Autism Therapy
NeuroNOS, a subsidiary of Beyond Air, has secured $2 million in equity financing from private investors to accelerate the preclinical development of its small-molecule drug targeting Autism Spectrum Disorder (ASD). The drug, designed for subcutaneous injection or oral administration, aims to regulate nitric oxide levels in the brain, potentially addressing underlying biological mechanisms of ASD. The research, based on discoveries by Prof. Haitham Amal, has shown promising preclinical results, demonstrating the potential to improve behavior and brain function in ASD. NeuroNOS is collaborating with the Hebrew University of Jerusalem and continues to raise additional capital for further development.
InvestmentPartners
Beyond Air Announces Agreements Expanding Global Distribution of LungFit® PH
Beyond Air, a commercial-stage medical device and biopharmaceutical company, has expanded its global distribution network for its LungFit PH system by signing new agreements in France, Turkey, Romania, and Morocco. This expansion increases the companys international presence to 18 countries. The LungFit PH system, which recently received CE Mark approval, generates nitric oxide from room air, eliminating the need for traditional high-pressure cylinders. This technology offers operational efficiencies and sustainability benefits in hospital settings. Beyond Air anticipates rapid commercial growth internationally, supported by established distribution partners. The company has received initial orders for the LungFit PH system in four countries.
PartnersCustomers
Beyond Air to Participate in Two Upcoming Healthcare Investor Conferences
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, is focused on using nitric oxide (NO) to treat various health conditions. The company has received FDA approval for its LungFit® PH system, designed for neonates with hypoxic respiratory failure. Beyond Air is advancing other LungFit systems in clinical trials for severe lung infections and has partnered with The Hebrew University of Jerusalem for a pre-clinical program targeting neurological disorders. Beyond Cancer, Ltd., an affiliate, is exploring NO for solid tumors. CEO Steve Lisi will participate in upcoming conferences to discuss the companys progress.
Product StagePartnersFDA approved/pending approval
Beyond Air Third Quarter 2025 Earnings: Beats Expectations
Beyond Air reported a significant increase in revenue, up 174% from the previous year, reaching US$1.07 million. The companys net loss narrowed by 20% to US$13.0 million, and the loss per share improved to US$0.15 from US$0.50. Revenue and earnings per share exceeded analyst estimates, with revenue surpassing by 15% and EPS by 6.3%. The companys shares have risen by 4.9% over the past week. Looking forward, Beyond Airs revenue is expected to grow at an average of 69% annually over the next three years, significantly outpacing the US Medical Equipment industrys forecasted growth of 7.8%.
Beyond Air® Reports Fiscal Third Quarter 2025 Financial Results and Provides Corporate Update
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, reported a 34% increase in revenue for the fiscal third quarter ended December 31, 2024. The company received a CE Mark for its LungFit PH system, allowing it to market the product in Europe and other regions recognizing the certification. Additionally, Beyond Air received market authorization in Australia and has signed partnerships with distributors in the Middle East. The company anticipates further regulatory approvals in eight countries under its partnership with Getz Healthcare by the end of 2025. Beyond Air plans to continue expanding its hospital network in the U.S. and expects ongoing revenue growth.
Product StageCustomersPartners
Beyond Air® Granted 180-Day Extension by Nasdaq to Regain Compliance with Minimum Bid Requirement
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, has been granted an additional 180-day compliance period by Nasdaq to meet the minimum bid price rule. The company must achieve a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days by August 4, 2025, to regain compliance. Beyond Air has received FDA approval for its LungFit® PH system and is advancing other LungFit systems in clinical trials. The company has partnered with The Hebrew University of Jerusalem for a pre-clinical program targeting autism spectrum disorder and other neurological disorders. Beyond Cancer, Ltd., an affiliate, is exploring treatments for solid tumors.
Public TradingFDA approved/pending approvalPartners
Beyond Air® Schedules Third Fiscal Quarter 2025 Financial Results Conference Call and Webcast
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, announced plans to report its fiscal third quarter 2025 financial results on February 10, 2025. The company focuses on harnessing nitric oxide to treat respiratory illnesses, neurological disorders, and solid tumors. Beyond Air has received FDA approval for its LungFit® PH system for treating neonates with hypoxic respiratory failure and is advancing other LungFit systems in clinical trials for severe lung infections. The company has partnered with The Hebrew University of Jerusalem to develop treatments for autism spectrum disorder and other neurological disorders. Beyond Cancer, an affiliate, is exploring ultra-high concentrations of nitric oxide for targeting solid tumors. The article highlights the companys progress and partnerships, indicating a positive growth trajectory.
FDA approved/pending approvalPartners
Beyond Air® Announces LungFit® PH Receives Market Authorization in Australia
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, announced that its LungFit PH device has received market authorization from the Australian Therapeutic Goods Administration (TGA) as a Class IIb medical device. The device, which generates nitric oxide from ambient air, is designed to deliver a constant concentration of nitric oxide to patients on ventilators. This approval follows the recent CE Mark approval in the European Union and FDA clearance in the United States. Beyond Air plans to begin shipments to Australia through its partner, Getz Healthcare, and anticipates further market approvals throughout 2025. The LungFit PH system supports hospital sustainability by reducing emissions associated with traditional nitric oxide delivery methods.
Product StagePartners
Insider Stock Buying Reaches US$1.60m On Beyond Air
The article discusses the insider buying activity at Beyond Air, Inc., highlighting that insiders have significantly increased their holdings over the past year. The most notable purchase was made by Independent Director Robert Carey, who bought shares worth $745k at $0.50 per share, which is above the current share price of $0.39. This indicates optimism about the companys prospects. Insiders own 15% of the company, valued at approximately $4.3 million, suggesting alignment with shareholder interests. The article also mentions that no insider has sold shares recently, and there are warning signs to consider before investing.
Beyond Air to Participate in the Lytham Partners 2025 Investor Healthcare Summit on January 13, 2025
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, is focused on utilizing nitric oxide (NO) to improve patient outcomes in respiratory and neurological conditions. The company has received FDA approval and CE Mark for its LungFit® PH system, designed for treating neonatal respiratory failure and pulmonary hypertension. Beyond Air is advancing its LungFit systems for severe lung infections and has partnered with The Hebrew University of Jerusalem for a pre-clinical program targeting autism spectrum disorder. Beyond Cancer, Ltd., an affiliate, is exploring NO for solid tumors. The company will present at the Lytham Partners 2025 Investor Healthcare Summit, highlighting its innovations and partnerships.
Product StagePartnersFDA approved
Beyond Cancer Announces Approval by the Israeli Ministry of Health to Conduct a Phase 1b Clinical Trial Utilizing Low Volume Ultra-High Concentration Nitric Oxide (LV UNO) in Combination with Anti-PD-1 Therapy
Beyond Cancer, Ltd., a clinical-stage biotechnology company, announced that the Israeli Ministry of Health has approved a Phase 1b clinical trial of Low Volume UNO (LV UNO) in combination with anti-PD-1 therapy. The trial will assess the efficacy and safety of LV UNO in patients with unresectable cutaneous or subcutaneous solid tumors that have progressed on PD-1 inhibitors. The study aims to enroll up to 20 subjects across four sites in Israel, with patient screening beginning in early 2025. The trial will evaluate the objective response rate and duration of response, as well as immune-related responses. Topline data are expected in the second half of 2025. This development is seen as a positive step in advancing potential treatments for solid tumors.
Beyond Air Receives CE Mark in Europe for the LungFit® PH System
Beyond Air, Inc., a medical device and biopharmaceutical company, announced the European CE mark approval for its LungFit PH system. This approval enables the company to market the device across the European Union and other regions recognizing the certification. The LungFit PH system, which uses patented Ionizer technology, is designed to treat hypoxic respiratory failure and pulmonary hypertension. Beyond Air has partnered with Business Asia Consultants for distribution and will receive a $1 million milestone payment from its Asia-Pacific partner, Getz Healthcare, following the CE mark certification. The partnership will also provide ongoing royalty payments based on sales. This development is expected to enhance Beyond Airs market presence and sales in Europe and other global regions.
Partners
NeuroNOS Appoints Nobel Laureate, Roger D. Kornberg, to Scientific Advisory Board
NeuroNOS, a subsidiary of Beyond Air, has appointed Nobel Prize-winning Professor Roger D. Kornberg to its Scientific Advisory Board. This strategic move is aimed at accelerating the development of treatments for Autism Spectrum Disorder (ASD) and other neurological conditions. Professor Kornbergs expertise in molecular biology will be instrumental in advancing NeuroNOSs mission to develop targeted therapies. The appointment underscores NeuroNOSs commitment to scientific innovation and improving the lives of individuals affected by neurological disorders. The addition of Professor Kornberg is seen as a significant step forward in enhancing the companys research and development initiatives.
Management Changes
Beyond Air to Participate in the Piper Sandler 36th Annual Healthcare Conference
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, announced its participation in the Piper Sandler 36th Annual Healthcare Conference from December 3-5, 2024. The companys CEO, Steve Lisi, will engage in one-on-one meetings and a fireside chat. Beyond Air focuses on utilizing Nitric Oxide (NO) to treat respiratory illnesses, neurological disorders, and solid tumors. The company has received FDA approval for its LungFit® PH system for treating neonatal hypoxic respiratory failure and is advancing other LungFit systems for severe lung infections. Beyond Air has partnered with The Hebrew University of Jerusalem to explore treatments for Autism Spectrum Disorder and other neurological disorders. Additionally, Beyond Cancer, Ltd., an affiliate, is researching NO delivery systems for solid tumors.
Partners
Beyond Cancer Presents Promising Preclinical Data on Low Volume Ultra-High Concentration Nitric Oxide (LV UNO) Therapy at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting
Beyond Cancer, Ltd., a clinical-stage biotechnology company, announced promising results from studies involving their ultra-high concentration nitric oxide (UNO) therapy. The studies, presented at the Society for Immunotherapy of Cancer Annual Meeting 2024, demonstrated that Low Volume UNO (LV UNO) combined with immune checkpoint inhibitors significantly improved tumor growth inhibition and survival rates in MAT B III tumor-bearing rats compared to using anti-rPD-L1 alone. Additionally, LV UNO was more effective than High Volume UNO in reducing tumor volumes in CT26 BALB/c mice when paired with anti-mPD-1 treatment. These findings suggest that LV UNO could offer enhanced patient benefits and safety, supporting further clinical evaluation.
Beyond Air® Reports Fiscal Second Quarter 2025 Financial Results and Provides Corporate Update
Beyond Air, a medical device and biopharmaceutical company, reported a 17% increase in revenues for the fiscal second quarter ended September 30, 2024. The company completed a $20.6 million private placement offering and retired $17.5 million in debt, entering into an $11.5 million loan agreement. Beyond Airs customer base grew by over 60%, with notable partnerships including TrillaMed, Healthcare Links, and Business Asia Consultants. The company is focusing on expanding its LungFit PH system, with deployments in hospitals like the U.S. Naval Hospital Guam. Strategic initiatives are expected to extend the companys cash runway through June 2026, supporting ongoing revenue growth and market expansion.
CustomersPartnersInvestment
Beyond Air® Schedules Second Fiscal Quarter 2025 Financial Results Conference Call and Webcast
Beyond Air, Inc., a medical device and biopharmaceutical company, announced plans to report its financial results for the second quarter of fiscal year 2025 on November 11, 2024. The company specializes in developing treatments for lung diseases using its LungFit® platform, a nitric oxide generation and delivery system. The announcement includes a conference call and webcast for investors and stakeholders. The press release contains forward-looking statements about the companys product offerings and potential impacts on patients. These statements are subject to risks and uncertainties, including regulatory approvals and competition. Beyond Air emphasizes its commitment to innovation in medical technology and improving healthcare efficiency.
Beyond Cancer to Present Preclinical Data of Ultra-High Concentration Nitric Oxide (UNO) Low Volume Therapy at the 2024 Society for Immunotherapy of Cancer (SITC) Annual Meeting
Beyond Cancer, Ltd., a clinical-stage biotechnology company, is set to present two poster presentations at the Society for Immunotherapy of Cancer (SITC) Annual Meeting 2024. The presentations will showcase the therapeutic efficacy of ultra-high concentration nitric oxide (UNO) in treating solid tumors in mice and rat models. The SITC meeting will take place from November 6-10, 2024, in Houston, Texas. The company aims to demonstrate the potential of UNO therapy in preventing relapse or metastatic disease with minimal toxicity. This event marks a significant milestone for Beyond Cancer as it highlights their innovative approach to cancer treatment, potentially enhancing their growth prospects.
Beyond Air Partners with Healthcare Links to Expand Access to LungFit® PH System Through Group Purchasing Organizations and Integrated Delivery Networks
Beyond Air, Inc., a medical device and biopharmaceutical company, has announced a strategic partnership with Healthcare Links to expand access to its LungFit® PH system. This partnership aims to streamline entry into Group Purchasing Organizations (GPOs) and Integrated Delivery Networks (IDNs) across the United States, enhancing the distribution of Beyond Airs innovative inhaled nitric oxide technology. The LungFit® PH system is designed to treat persistent pulmonary hypertension of the newborn and other respiratory conditions, offering significant operational efficiencies and safety improvements by generating nitric oxide on demand from ambient air. This collaboration is expected to broaden the reach of Beyond Airs technology, ensuring more hospitals can integrate this advanced respiratory therapy into their patient care protocols.
Partners
Beyond Air terminates loan, security agreements with Avenue Capital
Beyond Air has terminated its loan and security agreements with Avenue Capital and entered into an $11.5 million loan agreement with an insider-led investor group. The company has also reached an agreement to extinguish the Avenue Capital senior secured term loan for a one-time payment of $17.85 million, eliminating future debt and interest payments. Avenue Capital is investing $3.35 million in Beyond Air through a private placement equity offering. Beyond Air has increased its hospital contracts by 60%, including a contract with the U.S. Naval Hospital Guam, facilitated by TrillaMed. The company believes these financial moves will support operations through June 2026 but has withdrawn its previous revenue guidance for fiscal year 2025.
InvestmentPartnersCustomersManagement Changes
Beyond Air to sell 40.39M shares at 51c in private placement
Beyond Air has entered into a securities purchase agreement with institutional and accredited investors, including Company insiders, to raise approximately $20.6 million through a private placement offering. The offering includes 40,392,155 shares of common stock and accompanying warrants, with the gross proceeds intended for working capital purposes. The private placement is expected to close around September 30, 2024, subject to closing conditions. BTIG acted as the lead placement agent, with Laidlaw & Company, JonesTrading Institutional Services, and Brookline Capital Markets as co-placement agents.
Investment
Beyond Air Announces Termination of the Loan and Security Agreements with Avenue Capital
Beyond Air announced the retirement of $17.5 million in debt from Avenue Capital and entered into an $11.5 million loan agreement with an insider-led investor group. This restructuring eliminates $12 million in scheduled debt payments through June 2026 and defers principal and interest payments on the new loan until then. The company also reported a 60% increase in hospital contracts since July 2024, including a new partnership with the U.S. Naval Hospital Guam. These financial moves and new contracts are expected to strengthen Beyond Airs balance sheet and support its commercial efforts for LungFit PH.
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Beyond Air Provides LungFit® PH System to U.S. Naval Hospital Guam for Neonatal Critical Care in Partnership with TrillaMed
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, has announced the deployment of its LungFit® PH system to the U.S. Naval Hospital Guam. This partnership, facilitated by TrillaMed, aims to enhance neonatal critical care by providing advanced respiratory support for newborns. The LungFit® PH system generates nitric oxide from room air to treat persistent pulmonary hypertension in neonates. This collaboration underscores Beyond Airs commitment to improving patient outcomes and advancing neonatal care. The U.S. Naval Hospital Guam, serving a significant military community, will benefit from this state-of-the-art technology.
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Beyond Air Announces $20.6 Million Private Placement Offering Priced At-the-Market Under Nasdaq Rules
Beyond Air has strengthened its balance sheet through a series of financial maneuvers, including a $20.6 million private placement offering and the retirement of $17.5 million in debt from Avenue Capital. The company also secured an $11.5 million loan agreement led by board members. These actions are expected to provide sufficient cash runway through June 2026, allowing Beyond Air to focus on its commercial efforts for LungFit PH. The private placement involved institutional and accredited investors, including Avenue Capital and healthcare-focused funds. The company plans to use the net proceeds for working capital purposes.
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Beyond Air to Participate in the 3rd Annual ROTH Healthcare Opportunities Conference
Beyond Air, a commercial stage medical device and biopharmaceutical company, announced that its CEO, Steve Lisi, will participate in one-on-one meetings at the 3rd Annual ROTH Healthcare Opportunities Conference on October 9th. The company focuses on harnessing nitric oxide to improve patient lives and has received FDA approval for its LungFit PH system for treating neonates with hypoxic respiratory failure. Beyond Air is also advancing other LungFit systems in clinical trials for severe lung infections and has partnered with The Hebrew University of Jerusalem for a pre-clinical program on autism spectrum disorder. Additionally, Beyond Cancer, an affiliate, is investigating ultra-high concentrations of nitric oxide for targeting solid tumors.
Partners
Beyond Air First Quarter 2025 Earnings: EPS Beats Expectations, Revenues Lag
Beyond Air reported its Q1 2025 results, with a net loss of $12.2m, a 13% improvement from Q1 2024. The companys loss per share also improved, from $0.45 in Q1 2024 to $0.27 in Q1 2025. However, the companys revenue fell short of analyst estimates by 13%, while its earnings per share exceeded estimates by 15%. Looking ahead, the companys revenue is forecasted to grow 84% p.a. on average over the next three years. Despite these results, the companys shares are down 28% from a week ago.
Investment
Beyond Air® Reports Fiscal First Quarter 2025 Financial Results and Provides Corporate Update
Beyond Air, Inc., a medical device and biopharmaceutical company, has reported a 45% increase in revenues compared to the previous quarter ended March 31, 2024. The companys LungFit PH device continues to expand its footprint and strengthen its customer base. Beyond Air has also appointed Amir Avniel, a board member and Chief Business Officer, as the Chief Executive Officer of NeuroNOS, a subsidiary focused on neurological disorders. The company expects a revenue of at least $10 million for FY 2025. The company also reported a net loss of $12.2 million for the three months ended June 30, 2024.
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Beyond Air® Publishes Peer-Reviewed Journal Article in Scientific Reports with Clinical Data Showing Nitric Oxide was Safe and Beneficial Adjunct Therapy for Subjects with Viral Pneumonia
Beyond Air, Inc., a medical device and biopharmaceutical company, has announced the publication of a scientific article detailing the safety of its high-dose inhaled nitric oxide treatment for COVID-19-related viral pneumonia. The study, published in Scientific Reports, found the treatment to be well-tolerated, safe, and beneficial in treating adults hospitalized with the illness. Beyond Airs CEO, Steve Lisi, stated that the data will support further investigation of inhaled nitric oxide for treating viral and bacterial lung infections. The company is also advancing its LungFit systems in clinical trials for the treatment of severe lung infections.
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Beyond Air® to Report First Fiscal Quarter 2025 Financial Results on August 6
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, has announced that it will report financial results for its first fiscal quarter 2025 ended June 30, 2024 on Tuesday, August 6, 2024. The company is focused on harnessing the power of nitric oxide to improve the lives of patients suffering from respiratory illnesses, neurological disorders and solid tumors. Beyond Air has received FDA approval for its first system, LungFit® PH, and is currently advancing its other LungFit systems in clinical trials. 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.
CustomersPartners
Beyond Air® To Participate in the BTIG Virtual Biotechnology Conference 2024
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, announced that its CEO, Steve Lisi, will participate in one-on-one meetings at the BTIG Virtual Biotechnology Conference in August 2024. The company is dedicated to improving the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. It has received FDA approval for its LungFit PH system and is advancing other LungFit systems in clinical trials. Beyond Air has also partnered with The Hebrew University of Jerusalem for a pre-clinical program dedicated to the treatment of autism spectrum disorder (ASD) and other neurological disorders.
Management ChangesPartners
Beyond Air® Reports Fiscal Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update
Beyond Air, Inc., a medical device and biopharmaceutical company, has appointed David Webster as its new Chief Commercial Officer. The company has also upgraded its LungFit PH device, which is expected to expand its customer base and accelerate revenue growth each quarter. The company has revised its FY 2025 revenue guidance to more than $10 million. Beyond Air has also implemented a capital conservation strategy to reduce cash burn. The companys financial results for the fiscal fourth quarter and year ended March 31, 2024, were also announced.
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Beyond Air® Appoints David Webster as Chief Commercial Officer
Beyond Air, Inc., a medical device and biopharmaceutical company, has announced the appointment of David Webster as Chief Commercial Officer, effective July 8, 2024. Webster brings over 20 years of executive level experience in the life sciences industry and has successfully developed and executed several commercial strategies for medical devices and therapeutics. The appointment comes at a time when Beyond Airs LungFit PH is poised to take the lead in the nitric oxide (NO) market. The company is confident that Webster will drive significant market share gains.
Management Changes
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)
Beyond Cancer, Ltd., a clinical-stage biotech company, has announced encouraging data from its ongoing Phase 1a trial of ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors. The data shows evidence of immune system activation in a heavily pretreated population. The company also reported a case of relapsed/refractory Triple Negative Breast Cancer (TNBC) in which the subject showed no evidence of malignancy following UNO treatment. The Phase 1b trial has been submitted to the Israeli Ministry of Health (IMOH) for regulatory approval. Beyond Cancer believes that UNO has the potential to prevent relapse or metastatic disease with as little as a single 5-minute treatment.
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Beyond Air Up 11%, Insiders Still Down After US$3.05m Purchase
Insiders at Beyond Air, Inc. have purchased US$3.05m worth of the companys stock in the past year, with the stock rising by 11% last week. Despite this, the insiders have faced losses totalling US$1.0m since the time of purchase. The biggest insider purchase was by Independent Director Robert Carey, who bought US$2.0m worth of shares. Over the last year, insiders have bought 1.63m shares worth US$3.0m, and sold 14.69k shares for US$31k. Beyond Air insiders own 18% of the company, worth about US$10.0m.
Investment
Beyond Air® Schedules Fiscal Year End 2024 Financial Results Conference Call and Webcast
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, announced that it will report its financial results for the fiscal fourth quarter and full year ended March 31, 2024, on Monday, June 24, 2024. The company is focused on improving the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. Beyond Air has received FDA approval for its first system, LungFit® PH, and is advancing other LungFit systems in clinical trials. The company has also partnered with The Hebrew University of Jerusalem for a pre-clinical program dedicated to the treatment of autism spectrum disorder (ASD) and other neurological disorders.
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Beyond Cancer Selected to Present on the Clinical Development of Ultra-High Concentration Nitric Oxide (UNO) Therapy at the 2024 American Society of Clinical Oncology Annual Meeting
Beyond Cancer, Ltd., a clinical stage biotechnology company, has been selected to present on the clinical development program of its Ultra-High Concentration Nitric Oxide (UNO) at the American Society of Clinical Oncology (ASCO) Annual Meeting. The company will also host a Key Opinion Leaders (KOLs) event to discuss the clinical development program for UNO, including new data from the Phase 1 trial. The events aim to highlight the ongoing clinical development of UNO, a new approach to preventing relapse or metastatic disease in cancer treatment.
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Beyond Air® Announces Pricing of $16.0 Million Registered Direct Offering of Common Stock and Warrants
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, has entered into a securities purchase agreement with healthcare focused institutional investors and accredited investors, including certain directors and officers of the Company. 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 gross proceeds to the Company from this offering are expected to be approximately $16.0 million.
Investment
Beyond Air® Reports Financial Results for Third Quarter of Fiscal Year 2024
Beyond Air, Inc., a medical device and biopharmaceutical company, has reported a solid sequential revenue growth of more than 60% compared with the second quarter. The company is experiencing increasing demand for its LungFit PH system and expects to meet accelerating demand over the next several quarters. The FDA has accepted the PMA supplement for the expansion of the LungFit PH label to include cardiac surgery for filing and is currently under review. The companys Chief Commercial Officer, Duncan Fatkin, is set to leave the company on March 31, 2024. Beyond Air reported revenues of $0.4 million for the three months ended December 31, 2023.
CustomersManagement Changes
Beyond Air® Schedules Third Fiscal Quarter 2024 Financial Results Conference Call and Webcast
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, has announced that it will report financial results for its third fiscal quarter ended December 31, 2023 on Monday, February 12, 2024. The companys management team is scheduled to host a conference call and webcast at 4:30 pm Eastern Time the same day. Beyond Air is dedicated to improving the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. The company has received FDA approval for its first system, LungFit® PH, and is advancing its other LungFit systems in clinical trials.
CustomersPartners
Beyond Cancer™ Phase 1 Study Clears Cohort 1 in Patients with Advanced Relapsed or Refractory Unresectable Primary or Metastatic Cutaneous or Subcutaneous Solid Tumors
Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc., announced that the Phase 1 Study evaluating ultra-high concentration nitric oxide (UNO) in advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors has cleared the first cohort of 25,000 ppm single dose UNO by the Safety Review Committee with no reported dose limiting toxicities. The study is being conducted in two parts: Dose Escalation and Dose Expansion. The company is delighted to advance to the next cohort of the Phase 1 trial with no reported dose limiting toxicities.
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Beyond Air Independent Director Acquires 102% More Stock
Robert Carey, Independent Director of Beyond Air, Inc., has purchased shares worth US$2.0m at an average price of US$1.64, boosting his holding by 102%. This is the biggest insider purchase of Beyond Air shares in the last year. In the last twelve months, insiders paid US$3.9m for 1.76m shares, with more buying than selling. Insiders own 17% of Beyond Air shares, worth about US$12m. Despite the company not making a profit over the last twelve months, insiders seem confident of a bright future.
Investment
Director Robert Carey Acquires 1,200,000 Shares of Beyond Air Inc (XAIR)
On December 18, 2023, Robert Carey, a director at Beyond Air Inc, purchased 1,200,000 shares of the company, indicating confidence in the companys future performance. This adds to his total holdings of 1,582,837 shares in the past year. Beyond Air Inc is a clinical-stage medical device and biopharmaceutical company focusing on developing a nitric oxide generator and delivery system for various therapeutic applications. The companys shares were trading at $1.64 at the time of purchase, resulting in a market cap of $68.421 million.
Public Trading
Insider Buying: CEO Steven Lisi Acquires 77,775 Shares of Beyond Air Inc
Beyond Air Incs CEO and Chairman of the Board, Steven Lisi, purchased 77,775 shares of the companys stock on December 18, 2023, according to a recent SEC filing. This adds to a series of insider activities observed over the past year. Beyond Air Inc is a clinical-stage medical device and biopharmaceutical company developing products for various respiratory diseases. The companys shares were trading at $1.63 on the day of the insiders recent purchase, resulting in a market cap of $60.748 million.
Investment
Beyond Air® To Participate in the 35th Annual Piper Sandler Healthcare Conference
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, announced that its CEO, Steve Lisi, will participate in a fireside discussion and one-on-one meetings at the Piper Sandler Healthcare Conference in November 2023. The company focuses on harnessing the power of nitric oxide to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. Beyond Air has received FDA approval for its first system, LungFit® PH, and is advancing other LungFit systems in clinical trials. The company has also partnered with The Hebrew University of Jerusalem for a pre-clinical program dedicated to the treatment of autism spectrum disorder (ASD) and other neurological disorders.
Management ChangesPartners
Beyond Air® Reports Financial Results for Second Quarter of Fiscal Year 2024
Beyond Air, Inc., a medical device and biopharmaceutical company, has provided its fiscal year 2025 revenue guidance of $12 - $16 million. The company is currently conducting a US pilot trial of LungFit® PRO to treat viral community acquired pneumonia (VCAP), with data expected by mid-2024. Beyond Air has also submitted a PMA supplement to the FDA for the expansion of LungFit PH label to include cardiac surgery, with approval anticipated in the second half of 2024. The company has entered into an agreement with Getz Healthcare to commercialize the LungFit PH device in certain countries across the Asia-Pacific region.
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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
Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc., has announced positive first-in-human and first-in-class clinical data for its ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors. The data shows promising safety profile and clear evidence of immune system activation via biomarker response. The single agent treatment in relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous malignancies represents an unprecedented use of ultra-high concentration nitric oxide as an immunotherapeutic. Additional Phase 1 data for UNO is expected in 2024.
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Beyond Air® Schedules Second Fiscal Quarter 2024 Financial Results Conference Call and Webcast
Beyond Air® To Participate in the Truist Securities BioPharma Symposium
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
Beyond Air® Receives Innovative Technology Contract from Vizient for LungFit®PH
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
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
Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc., is set to 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. The company is developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors. The presentations will detail the use of UNO and its impact on tumor regression rates and survival in tumor-bearing mice, as well as its enhancement of anti-CTLA-4 treatment activity and induction of a durable anti-tumor response.
Investment
Beyond Air® To Participate in the Roth MKM 2023 Healthcare Opportunities Conference
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, announced its participation in the Roth MKM 2023 Healthcare Opportunities Conference on October 12, 2023. The company will present a corporate overview and participate in one-on-one meetings. Beyond Air is dedicated to improving the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors through the power of endogenous and exogenous nitric oxide. The company has received FDA approval for its LungFit® PH system and is advancing other LungFit systems in clinical trials.
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Beyond Cancer™ to Present Initial Clinical Data for Ultra-High Concentration Nitric Oxide Therapy at the 2023 SITC Annual Meeting
Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc., is set to present data at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in 2023. The company is developing ultra-high concentration nitric oxide (UNO) as an immunotherapeutic for solid tumors. The presentation will detail a Phase 1 study of UNO ablation in relapsed refractory, unresectable, primary, or metastatic cutaneous and subcutaneous malignancies. Beyond Air is also advancing its LungFit systems in clinical trials for the treatment of severe lung infections, including COVID-19.
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Beyond Air® Announces Publication of Positive New Preclinical Data for the Treatment of Autism Spectrum Disorder
Beyond Air, Inc., a medical device and biopharmaceutical company, has announced new data supporting the ongoing preclinical development of selective neuronal nitric oxide synthase (nNOS) inhibitors for the treatment of Autism Spectrum Disorder (ASD). The data, published by the Hebrew University of Jerusalem (HUJI), suggests that a slow-release formulation of the nNOS inhibitor can reverse behavioral phenotypes and nitrosative stress in a mouse model of autism for at least 10 days after a single injection. Beyond Air is collaborating with HUJI under a research and license agreement to develop these inhibitors for ASD treatment.
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Beyond Air Insiders Placed Bullish Bets Worth US$2.3m
Insiders at Beyond Air, Inc. have significantly increased their holdings in the company over the past year. The biggest insider purchase was by Independent Director Robert Carey, who bought shares worth US$674k. In total, insiders bought 575.25k shares for US$2.3m, while selling 48.60k shares worth US$296k. The average buy price was around US$4.07. Beyond Air insiders own about US$17m worth of shares, equating to 17% of the company. Despite the company making a loss during the last year, insiders transactions suggest they see value in Beyond Air shares.
Investment
Beyond Air® and Getz Healthcare Enter Strategic Collaboration to Commercialize LungFit PH in Asia-Pacific Region
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, has entered into a partnership with Getz Healthcare to commercialize the LungFit PH device in certain Asia-Pacific countries. Under the agreement, Getz Healthcare will make a payment to Beyond Air upon receipt of CE Mark and will also pay royalties based on net sales. The partnership will provide access to hospitals in Australia, New Zealand, Thailand, Philippines, Taiwan, Hong Kong, Malaysia, Pakistan, Singapore and Vietnam. BTIG, LLC acted as the financial advisor to Beyond Air, Inc.
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Beyond Air® To Participate in the 2023 Cantor Global Healthcare Conference
Beyond Air® Reports Financial Results for First Quarter of Fiscal Year 2024
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, has reported commercial sales for its LungFit PH product for the treatment of term and near-term neonates with hypoxic respiratory failure. The company has secured up to $40 million in debt financing from Avenue Capital and has reached an agreement with the FDA to run a U.S. clinical study in patients hospitalized with viral community acquired pneumonia (VCAP). The company has also expanded its pipeline with the addition of a pre-clinical program for selective neuronal nitric oxide synthase (nNOS) inhibitors for the treatment of autism spectrum disorder and other indications.
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2 ‘Strong Buy’ Penny Stocks That Could Rally All the Way to $10 (or More)
The article discusses the potential of penny stocks, specifically focusing on Milestone Pharmaceuticals and Beyond Air. Milestone Pharmaceuticals is a clinical-stage biopharma firm working on an innovative therapy for cardiovascular conditions. The company is developing a drug candidate, etripamil, for the treatment of PSVT, atrial fibrillation, and rapid ventricular rate. Beyond Air is a biotech medical researcher working on new treatments for severe lung conditions. The companys treatment mode involves the use of nitric oxide (NO), which is used to treat lung infections, pulmonary hypertension, chronic obstructive pulmonary disease (COPD), and even some solid tumor cancers.
Investment
Beyond Air® Announces Positive Preclinical Data on Role of Nitric Oxide in Autism Spectrum Disorder (ASD)
Beyond Air, Inc., a medical device and biopharmaceutical company, has announced the presentation of data supporting the ongoing preclinical development of selective neuronal nitric oxide synthase (nNOS) inhibitors for the treatment of Autism Spectrum Disorder (ASD). The data will be presented at the 2023 International Society of Neurochemistry (ISN) and the European Society of Neurochemistry (ESN) meeting in Portugal. The company has collaborated with the Hebrew University of Jerusalem for this research. The data shows that the inhibition of NO production may reverse ASD phenotypes, and NO is a novel target for the treatment of ASD and other neurological disorders.
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Beyond Air® To Participate in BTIG’s 2023 Virtual Biotechnology Conference
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, announced that its Chairman and CEO, Steve Lisi, will present a corporate overview and participate in one-on-one meetings at BTIG’s Virtual Biotechnology Conference on August 7, 2023. The company focuses on improving the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. Beyond Air has received FDA approval for its LungFit® PH system for the treatment of term and near-term neonates with hypoxic respiratory failure and is advancing other LungFit systems in clinical trials.
Management ChangesPartners
Growth-Positive for Block, Coursera, New York Community Bancorp, Crocs, XPeng, Palantir, Yelp, TeraWulf, Hims & Hers, Beyond Air; Growth-Negative for Southwest, Wingstop, Mersana Therapeutics, Enphase Energy, Shyft Group
Block upgraded, Southwest downgraded: Wall Street's top analyst calls
Several companies have been upgraded and downgraded by Wall Street analysts. Block, Coursera, New York Community Bancorp, Crocs, XPeng, Palantir, Yelp, TeraWulf, Hims & Hers, and Beyond Air have been upgraded by various analysts, with new price targets set. Meanwhile, Southwest, Wingstop, Mersana Therapeutics, Enphase Energy, and Shyft Group have been downgraded, with analysts setting lower price targets for these companies.
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Beyond Air® Schedules First Fiscal Quarter 2024 Financial Results Conference Call and Webcast
Beyond Air, Inc., a commercial stage medical device and biopharmaceutical company, announced that it will report its financial results for the first fiscal quarter ended June 30, 2023, on Thursday, August 10, 2023. The company focuses on harnessing the power of nitric oxide to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. Beyond Air has received FDA approval for its LungFit® PH system and is advancing other LungFit systems in clinical trials. The company has also partnered with The Hebrew University of Jerusalem for a pre-clinical program dedicated to the treatment of Autism Spectrum disorder and other neurological disorders.
Investment
Beyond Air® Reports Financial Results for Fourth Quarter and Fiscal Year-End 2023
Beyond Air, Inc. has announced its financial results for its fiscal fourth quarter and year ended March 31, 2023. The company has successfully completed phase 1 of its U.S. commercial launch, with multiple hospitals contracted, and has initiated phase 2 of the launch for LungFit® PH. Beyond Air has also presented positive preclinical data for ultra-high concentration nitric oxide (UNO) therapy in solid tumors and secured up to $40 million in debt financing. The company has also licensed commercial rights to selective neuronal nitric oxide synthase (nNOS) inhibitors for the treatment of autism spectrum disorder from Hebrew University of Jerusalem.
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Beyond Air® Secures up to $40 Million Debt Financing
Beyond Air, Inc. has secured a senior secured debt financing of up to $40 million from funds managed by Avenue Capital Group. The funding will support the commercial launch of LungFit PH and the clinical development of the LungFit platform. The term loan has a four-year term and will be funded across three tranches. Beyond Airs Chairman and CEO, Steve Lisi, expressed satisfaction with the partnership with Avenue Capital and the fundings impact on the companys balance sheet. Chad Norman, Senior Portfolio Manager at Avenue Capital, praised Beyond Airs technology and its potential to improve the lives of patients with respiratory conditions.
Investment
Beyond Air® Licenses Commercial Rights to Selective Neuronal Nitric Oxide Synthase (nNOS) Inhibitors for the Treatment of Autism Spectrum Disorder from Hebrew University of Jerusalem
Beyond Air, Inc., a medical device and biopharmaceutical company, has entered into a licensing agreement with Yissum Research Development Company of the Hebrew University of Jerusalem, LTD. The agreement grants Beyond Air commercial rights for multiple neuronal nitric oxide synthase (nNOS) inhibitor candidates, which are being developed for the treatment of autism spectrum disorder (ASD) and other neurological conditions. Beyond Air plans to initiate a first-in-human clinical trial of nNOS for ASD treatment in 2025. The company will pay the Hebrew University of Jerusalem, LTD. fees associated with certain pre-clinical, clinical, regulatory and sales milestones.
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Beyond Air® Schedules Fiscal Year End 2023 Financial Results Conference Call and Webcast
Beyond Air, Inc. will report financial results for its fiscal fourth quarter and year ended March 31, 2023 on June 22, 2023. The company is a commercial stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide for the treatment of respiratory conditions. They have received FDA approval for their first system, LungFit PH, and are advancing other LungFit systems in clinical trials for the treatment of severe lung infections. Beyond Airs affiliate, Beyond Cancer, is investigating ultra-high concentrations of nitric oxide for the treatment of solid tumors in the pre-clinical setting.
Public Trading
Beyond Cancer™ Presents Positive Preclinical Data for Ultra-High Concentration Nitric Oxide (UNO) Therapy in Solid Tumors During the American Association for Cancer Research (AACR) 2023 Annual Meeting
Beyond Air® Appoints Jeff Myers, M.D. Ph.D. as Chief Medical Officer
Beyond Cancer™ to Present Two Posters for Ultra-High Concentration Nitric Oxide (UNO) Therapy at the 2023 AACR Annual Meeting
Beyond Air® Announces Participation at Two Upcoming Investor Conferences in March 2023
Beyond Air® Reports Financial Results for the Third Quarter of Fiscal Year 2023
Beyond Cancer® Appoints Gavin Choy, PharmD as Chief Operating Officer
Beyond Cancer® Announces Sponsored Research Agreement with Stanford and Appointment of Frederick M. Dirbas, MD and Mark D. Pegram, MD to Scientific Advisory Board
Beyond Air® Schedules Third Fiscal Quarter 2023 Financial Results Conference Call and Webcast
Beyond Cancer® Publishes Pre-Clinical Data in Cancer Cell International Demonstrating Its Tumor Ablation Method Utilizing Ultra-High Concentration Nitric Oxide (UNO) Induced a Systemic Response that Prevents Metastases
Beyond Air® To Participate in Piper’s 34th Annual Healthcare Conference
Beyond Air® To Participate in Piper's 34th Annual Healthcare Conference
Beyond Air, Inc. announced that its Chairman and CEO, Steve Lisi, will be presenting a corporate overview and participating in 1x1 meetings at the Piper 34th Annual Healthcare Conference. Beyond Air is a medical device and biopharmaceutical company focused on developing inhaled nitric oxide for the treatment of respiratory conditions. The company has received FDA approval for its first system, LungFit PH, and is advancing other LungFit systems in clinical trials for the treatment of severe lung infections. Beyond Airs affiliate, Beyond Cancer, is investigating ultra-high concentrations of nitric oxide for the treatment of solid tumors. The companys participation in the conference suggests a positive growth outlook.
Partners
Beyond Cancer™ Presents Promising New In Vivo Data Showing Ultra-High Concentration Nitric Oxide Therapy (UNO) in Combination with Anti-PD-1 During the Society for Immunotherapy of Cancer (SITC) 2022 Annual Meeting
Beyond Air, Ltd., an affiliate of Beyond Air, Inc., has announced promising new in vivo combination data that support the potential of their gaseous nitric oxide (gNO) therapy to treat solid tumors in combination with immune checkpoint inhibitor (ICI) therapies. The data show higher tumor regression rates and prolonged survival in mice treated with UNO in combination with anti-PD-1 treatment. The company believes these results provide a strong rationale for the continued advancement of their program. Beyond Air is a medical device and biopharmaceutical company focused on harnessing the power of nitric oxide for the treatment of pulmonary diseases. They have developed the LungFit® NO Generator and Delivery System for precise delivery of nitric oxide to the lungs.
CustomersPartners
Beyond Air® Reports Financial Results for the Second Quarter of Fiscal Year 2023
Beyond Air, Inc., a medical device and biopharmaceutical company, has announced its financial results for Q2 2022. The company has received FDA approval for its LungFit PH treatment for neonates with hypoxic respiratory failure and is in the process of launching the product. The demand for product evaluations and demonstrations has exceeded expectations. Beyond Air also presented positive data from the pilot study of its LungFit GO for nontuberculous mycobacterial lung infection. The companys affiliate, Beyond Cancer, is developing ultra-high concentration nitric oxide for the treatment of solid tumors. The company reported a net loss of $12.8 million for the quarter.
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Beyond Air® Reports Financial Results for the Second Quarter of Fiscal Year 2023
Beyond Air® Announces Positive Data for Inhaled Nitric Oxide (NO) to Treat COVID-19 with LungFit® PRO in a Poster Presentation at IDWeek 2022
Beyond Air® Schedules Second Fiscal Quarter 2023 Financial Results Conference Call and Webcast
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
Beyond Cancer™ to Present Pre-Clinical Data for Ultra-High Concentration Nitric Oxide Therapy at the 2022 SITC Annual Meeting
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
Beyond Air® To Participate in Three Upcoming Investor Conferences
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 says U.S. launch of LungFit system unlikely before year-end (NASDAQ:XAIR)
Beyond Air shares have dropped after the company indicated that its U.S. commercial launch of LungFit PH is unlikely to happen before Dec. 31, 2021. However, the company reiterated its timeline to receive the CE Mark for LungFit PH in Europe in H1 2022. Beyond Air has seen a rise in value in 2021 and has attracted Bullish views on Wall Street.
Public Trading
Beyond Air Receives Approval from Health Canada to Study Nitric Oxide Generated and Delivered by the LungFit™ in COVID-19 Patients
Beyond Air, Inc. has received approval from Health Canada to conduct a study using their LungFit system for the treatment of COVID-19 patients. The study will assess the safety and efficacy of inhaled Nitric Oxide (NO) at different concentrations. Part 1 of the study will enroll 10 adult patients and assess safety at 80 ppm NO, while Part 2 will enroll 40 adult patients and assess safety and efficacy at 150 ppm NO. The primary endpoint of the study is time to clinical deterioration. Beyond Air is focused on developing NO treatments for respiratory conditions and pulmonary hypertension. The company aims to complete the study quickly to demonstrate the potential of the LungFit system in treating COVID-19 patients.
CustomersPartners
Beyond Air to Initiate Clinical Study Evaluating High Concentration Nitric Oxide for the Treatment of COVID-19 Patients in the United States
Beyond Air Accelerates LungFit™ BRO COVID-19 Program
Beyond Air Signs Agreement with MESA Specialty Gases & Equipment for Nitric Oxide and Nitrogen Dioxide Calibration Gas Supply
Beyond Air, Inc. has announced an exclusive five-year global supply agreement for NO and NO2 calibration gas with MESA Specialty Gases & Equipment. The agreement is suitable for all LungFit systems developed by Beyond Air. The partnership secures a critical piece of the puzzle for the companys LungFit systems on a global basis. Beyond Air will be responsible for the initial and future costs for adjustments to MESA facilities to meet capacity requirements. The deal is exclusive on a global basis to both companies. NO and NO2 calibration gases are essential for monitoring the proper delivery of NO and safety levels of NO2 in the LungFit systems.
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Beyond Air™ Provides Update on High Concentration Nitric Oxide (NO) Animal Studies Using LungFit™
Beyond Air, Inc. has successfully completed a 30-day rat toxicology study and provided an update on its 12-week toxicology studies in rats and dogs. The studies demonstrated the safety of high concentration Nitric Oxide (NO) dosed intermittently, which supports the companys planned clinical studies for bronchiolitis and nontuberculous mycobacteria (NTM). Beyond Airs LungFit™ NO Generator and Delivery System, a cylinder-free, phasic flow NO delivery system, has been designated as a medical device by the FDA. The system has the potential to replace large, high-pressure NO cylinders and deliver NO at concentrations above 80 ppm. Beyond Air intends to offer NO treatment in the home setting. The company is developing treatments for pulmonary hypertension and lower respiratory tract infections.
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Lung Diseases Treatment Company Raises $9.8 Million in Private Placement
AIT Therapeutics Inc., an Israel-based biotech company, has raised $9.8 million in a private placement. The funding will be used to support the companys ongoing clinical programs, including the development of nitric oxide-based treatments for lung-related conditions such as bronchiolitis and cystic fibrosis. AITs device can generate nitric oxide from the surrounding air and has the potential to be used as an at-home solution for patients. The company is currently conducting a study in Israel and plans to start a pivotal study in the U.S. later this year.
Investment
Advanced Inhalation Therapies raises $10m - Drug Delivery Business
Advanced Inhalation Therapies closed a $10.2 million offering, with 39 investors contributing. The Israel-based company is developing a drug delivery device to treat severe respiratory infections and lung diseases using a high dose of nitric oxide. AIT plans to use the funds to compensate Ladenburg Thalmann & Co. Inc. and for executive officers, directors, or promoters. AITs NOxSysBS device delivers 160 ppm of nitric oxide, which is higher than the FDA-approved treatment. The company had scaled back its pending IPO in 2020 and plans to list on NASDAQ under the symbol AITP.
InvestmentPublic Trading
Advanced Inhalation Therapies set for $12m IPO
Israeli drug development company Advanced Inhalation Therapies (AIT) has submitted a revised draft prospectus for its imminent IPO on Nasdaq. The company plans to raise $12 million gross ($8.5-9 million net) and will be traded on the secondary Nasdaq index under the AIT ticker symbol at a company value of $35 million. AIT will offer 675,000 units at $15 a unit. Some existing shareholders and members of the company board of directors plan to spend $500,000 on buying units in the offering. AITs CEO is former Rosetta Green CEO Amir Avniel, and its active chairman is former Keryx Biopharmaceuticals CEO Ron Bentsur.
Public TradingInvestment
Israeli biomed co AIT files for $40m Wall St IPO
Rehovot-based Israeli biomedical company Advanced Inhalation Therapies (AIT) has submitted a prospectus for a Wall Street IPO. The company plans to raise $30-40 million, although the company value for the offering has not been disclosed. AIT is developing products for the treatment of respiratory passage infections, with four products in its pipeline. The most progress has been made with the drug for cystic fibrosis, which has been granted orphan drug status by the FDA. AIT plans to use the IPO proceeds to complete its clinical trials and for general business needs.
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