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Beyond Air, Inc. (symbol: XAIR) is a clinical-stage medical device and biopharmaceutical company focused on revolutionizing respiratory disease treatments through innovative technology. The company's flagship product is the LungFit™ system, a Nitric Oxide (NO) Generator and Delivery System that uses NO generated from ambient air to deliver precise amounts of NO to the lungs of both ventilated and non-ventilated patients. This breakthrough technology is aimed at treating various pulmonary diseases, including pulmonary hypertension, severe lung infections such as SARS-CoV-2, and nontuberculous mycobacteria (NTM).
LungFit™ can generate up to 400 ppm of NO, offering flexibility in delivery either continuously or for a fixed period. It also features the ability to titrate the dose on demand or maintain a constant dose. This system is currently advancing in clinical trials and has garnered attention for its potential in treating lower respiratory tract infections that are not effectively addressed by current standards of care.
Beyond Air is also exploring ultra-high concentrations of NO with a proprietary delivery system separate from LungFit™ to target certain solid tumors. This preclinical testing aims to offer new hope for cancer treatments, making Beyond Air a pioneer in utilizing NO for diverse therapeutic applications.
Notably, Beyond Air has achieved significant milestones, including FDA approval for its LungFit® PH system designed for treating term and near-term neonates with hypoxic respiratory failure. The company has partnered with The Hebrew University of Jerusalem to develop treatments for neurological disorders like autism spectrum disorder (ASD). In addition, Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating ultra-high concentrations of NO to target specific solid tumors.
Financially, Beyond Air has shown a commitment to growth, as evidenced by its recent increase in general and administrative expenses, primarily driven by stock-based compensation and professional fees. The company maintains a forward-looking stance, aiming to expand its product portfolio and enhance its market position.
For more detailed information on their latest developments and product offerings, visit Beyond Air's official website.
Beyond Air (NASDAQ: XAIR), a commercial stage medical device and biopharmaceutical company specializing in Nitric Oxide (NO) treatments, has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The event will take place from December 3-5, 2024, in New York. Steve Lisi, the company's Chairman and CEO, will engage in one-on-one meetings and lead a fireside chat scheduled for Wednesday, December 4, 2024, at 4:30 pm ET.
Beyond Air (NASDAQ: XAIR) reported fiscal Q2 2025 results with revenues of $0.8 million, up 17% from the previous quarter. The company strengthened its balance sheet through a $20.6 million private placement and restructured its debt, retiring $17.5 million from Avenue Capital while securing an $11.5 million loan agreement. Commercial progress includes a 60% increase in hospital contracts and $3.5 million in annualized contracted revenue as of October 1, 2024. The company's cash position of $28.4 million, combined with expected revenue growth, is projected to provide runway through June 2026.
Beyond Cancer presented promising preclinical data on Low Volume Ultra-High Concentration Nitric Oxide (LV UNO) therapy at SITC 2024. The study showed that LV UNO combined with anti-rPD-L1 doubled tumor growth inhibition and improved survival in MAT B III tumor-bearing rats compared to anti-rPD-L1 alone. Additionally, LV UNO proved more effective than High Volume UNO in reducing tumor volumes in CT26 BALB/c mice when combined with anti-mPD-1 treatment. The research demonstrated enhanced nitro-tyrosine staining with LV UNO, indicating better tumor distribution of nitric oxide and potential improved safety outcomes.
Beyond Air (NASDAQ: XAIR), a commercial stage medical device and biopharmaceutical company focused on nitric oxide (NO) treatments, has scheduled its fiscal Q2 2025 financial results conference call for November 11, 2024, after market close. The earnings call will be held at 4:30 PM ET, accessible via phone (domestic: 1-877-407-0784; international: 1-201-689-8560) and webcast through the company's website. A replay will be available online after the call.
Beyond Cancer, , a clinical stage biotechnology company, has been selected to present two poster presentations at the upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting 2024. The event is scheduled for November 6-10 at the George R. Brown Convention Center in Houston, Texas. The company will showcase preclinical data on their ultra-high concentration nitric oxide (UNO) Low Volume Therapy.
The presentations will focus on the intratumoral administration of low volume high-concentration nitric oxide in combination with immune checkpoint inhibitors in different tumor models. The studies demonstrated therapeutic efficacy in both mice and rat tumor models. Abstracts will be released to SITC registrants on November 5, 2024, at 9:00 AM U.S. ET, while the full poster presentations will take place on November 8th and 9th. ePublications of the posters will be available on the company's website on November 7th.
Beyond Air (NASDAQ: XAIR) has announced a strategic partnership with Healthcare Links to expand access to its LungFit® PH system through Group Purchasing Organizations (GPOs) and Integrated Delivery Networks (IDNs) across the United States. The LungFit® PH system is a groundbreaking inhaled nitric oxide (NO) generator and delivery system for treating persistent pulmonary hypertension of the newborn (PPHN) and other respiratory conditions.
This partnership aims to streamline the entry of Beyond Air's technology into healthcare systems, leveraging Healthcare Links' expertise in facilitating relationships with GPOs and IDNs. The LungFit® PH system generates NO on-demand from ambient air, eliminating cylinder storage needs and enhancing patient safety and operational efficiency. The collaboration is expected to fast-track the availability of LungFit PH to a larger network of hospitals and healthcare providers, potentially benefiting more patients, particularly vulnerable newborns.
Beyond Air, Inc. (NASDAQ: XAIR) has deployed its LungFit® PH system to the U.S. Naval Hospital Guam for neonatal critical care, in partnership with TrillaMed. The LungFit® PH system generates Nitric Oxide (NO) from room air to treat persistent pulmonary hypertension in neonates (PPHN). Key features include a portable design, advanced NO generating technology, and easy integration into hospital infrastructure.
The U.S. Naval Hospital Guam serves over 17,000 active-duty military personnel and family members, with an expected increase of 2,500 in the next two years. The hospital currently delivers an average of 315 babies per year, projected to rise to 487 births by 2033. This deployment demonstrates the hospital's commitment to utilizing advanced technologies in neonatal care for military families.
Beyond Air (NASDAQ: XAIR) has announced significant financial restructuring, terminating its loan agreements with Avenue Capital and entering a new $11.5 million loan agreement with an insider-led investor group. The company is retiring $17.5 million in Avenue Capital debt, eliminating $12 million in scheduled debt payments through June 2026. The new loan agreement defers payment of principal and interest until June 2026.
Notably, Beyond Air reports a 60% increase in hospital contracts since July 1, 2024, including a contract with U.S. Naval Hospital Guam. The company's CEO, Steve Lisi, emphasized that these transactions strengthen the balance sheet, extend cash runway, and support commercial momentum for LungFit PH. David Webster, Chief Commercial Officer, expressed confidence in LungFit PH's potential to gain significant market share in the United States and globally.
The company is withdrawing its previous revenue guidance for fiscal year 2025 but believes the financial restructuring will provide sufficient cash runway through June 2026.
Beyond Air (NASDAQ: XAIR) has announced a $20.6 million private placement offering priced at-the-market under Nasdaq rules. The company is selling 40,392,155 shares of common stock (or pre-funded warrants) and accompanying warrants at $0.51 per share. This financing is expected to provide sufficient cash runway through June 2026.
Additionally, Beyond Air is retiring $17.5 million in Avenue Capital debt, aided by $11.5 million in new debt from an insider-led group. This eliminates $12 million in scheduled debt payments through June 2026. The company has also entered into an $11.5 million royalty funding agreement based on net sales of LungFit PH.
The private placement is expected to close around September 30, 2024, subject to certain conditions. BTIG, acted as the lead placement agent, with Laidlaw & Company, JonesTrading, and Brookline Capital Markets as co-placement agents.
Beyond Air, Inc. (NASDAQ: XAIR), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve patients' lives, has announced its participation in the 3rd Annual ROTH Healthcare Opportunities Conference. The event will take place on October 9th at the Metropolitan Club in New York.
Steve Lisi, Chairman and Chief Executive Officer of Beyond Air, will be available for one-on-one meetings during the conference. Interested parties are encouraged to contact their ROTH representative to schedule a meeting. This participation provides an opportunity for Beyond Air to engage with potential investors and industry professionals, showcasing their innovative work in nitric oxide-based medical solutions.
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