Workflow
Beyond Air(XAIR)
icon
Search documents
Beyond Air(XAIR) - 2026 Q2 - Quarterly Results
2025-11-14 21:30
Exhibit 99.1 Beyond Air® Reports Fiscal Second Quarter 2026 Financial Results and Provides Corporate Update Increased revenue by 128% year over year (YoY) to $1.8 million Appointed Beyond Air Board member Bob Goodman as Interim Chief Commercial Of icer Raised $12.0 million in debt financing; proforma cash, cash equivalents, restricted cash and marketable securities of $22.9 million as of September 30, 2025 Achieves certificate for Medical Device Single Audit Program (MDSAP) Updated fiscal year 2026 revenue ...
Beyond Air(XAIR) - 2026 Q2 - Earnings Call Transcript
2025-11-10 22:30
Financial Data and Key Metrics Changes - Revenue for the fiscal second quarter increased by 128% year-over-year, reaching $1.8 million, up from $0.8 million in the same period last year [4][15] - The company reported a gross loss of $0.3 million for the fiscal second quarter, an improvement from a loss of $1.1 million for the same period last year [16] - Net loss attributed to common stockholders was $7.9 million, or a loss of $1.25 per share, compared to a net loss of $13.4 million, or a loss of $5.67 per share, for the same quarter last year [18] Business Line Data and Key Metrics Changes - The company introduced a capital purchase sales model in the U.S. and had its first hospital purchase of LungFit PH [6] - The sales pipeline remains robust, with substantial opportunities across the U.S. as awareness of LungFit PH builds [4] Market Data and Key Metrics Changes - The company added new distribution partnerships in Japan, South Korea, Mexico, Costa Rica, Guatemala, Panama, and El Salvador, expanding its international coverage to 35 countries [10][11] - The company anticipates reaching its goal of 60 countries under partnership by calendar 2026 [11] Company Strategy and Development Direction - The company is preparing for the launch of its second-generation LungFit system, expected in late calendar 2026, pending FDA approval [8] - A national group purchasing agreement for therapeutic gases with Premier has been awarded, providing access to nearly 3,000 hospitals [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the trajectory of growth post-launch of the second-generation LungFit PH, anticipating a steeper growth curve [23] - The company is navigating complexities in hospital sales cycles, with expectations for sequential growth to resume in upcoming quarters [4] Other Important Information - The company raised $12 million in debt and plans to file a registration statement for an additional $20 million through an equity line of credit [5] - The company reported a 37% reduction in total operating expenses year-over-year, down to just above $7.4 million from $11.7 million [16] Q&A Session Summary Question: Expected growth drivers leading into the potential approval of the second-generation LungFit PH - Management believes the trajectory post-launch will be significantly steeper, with international expansion and the introduction of a capital purchase model as key growth drivers [23][24] Question: Comments on timing for commercialization of the second-gen LungFit PH - Management indicated that FDA timing is not the limiting factor, but supply chain issues are affecting the timeline [26] Question: Comparison between the new model and prior ones - The second-generation machine will be about 60% the size of the original, with improved user interface and longer maintenance intervals [28][29] Question: Insights on international deals and pricing models - The international model involves selling to distributors who then use various models, including capital equipment purchases and disposables [33] Question: Update on the updated guidance of $8 million-$10 million - Management noted that the transition in leadership may cause some disruption, but the revenue target is achievable based on current performance [35][36]
Beyond Air(XAIR) - 2026 Q2 - Quarterly Report
2025-11-10 22:15
Product Approvals and Market Potential - The LungFit PH system received FDA premarket approval in June 2022 and is indicated for improving oxygenation in neonates with hypoxic respiratory failure, with the ability to deliver NO up to 400 ppm [118]. - The company expects U.S. sales potential for LungFit PH to be approximately $350 million and worldwide sales potential to exceed $700 million [131]. - The company received European CE mark approval for LungFit PH on November 26, 2024, and has since received regulatory approvals in multiple countries including Australia and New Zealand [130]. - The LungFit PRO system is being piloted for treating viral pneumonia, with a U.S. market potential exceeding $1.5 billion and worldwide potential over $3 billion [132]. - The U.S. market potential for bronchiolitis is estimated to exceed $500 million, while the worldwide market potential is over $1.2 billion [137]. - The U.S. sales potential for NTM lung infections is projected to be greater than $1 billion, with worldwide sales potential exceeding $2.5 billion [143]. Clinical Trials and Research Findings - In a pilot clinical trial for LungFit PRO, inhaled NO treatment showed a trend of shortening length of stay by a factor of 1.8 compared to standard treatment [134]. - The clinical trial for bronchiolitis showed that 150 ppm NO significantly reduced hospital length of stay and accelerated time to stable oxygen saturation compared to control [138]. - The long-term safety data indicated a favorable re-hospitalization rate for the inhaled NO group, with no serious adverse events reported [140]. - A clinical trial for NTM lung disease received a grant of up to $2.17 million from the Cystic Fibrosis Foundation to advance inhaled NO treatment [144]. - Positive interim data from the NTM clinical trial showed high treatment compliance (>90%) and improvement in quality-of-life domains [146]. Corporate Developments and Financial Performance - The company has reorganized its oncology business into a new private company, Beyond Cancer, with an 80% ownership stake [121]. - Beyond Cancer raised $30 million in a private placement to accelerate preclinical work and clinical trials for UNO therapy [149]. - Revenues for the three months ended September 30, 2025, were $1.8 million, up from $0.8 million in the same period in 2024, representing a 125% increase [166]. - For the six months ended September 30, 2025, revenues were $3.6 million, compared to $1.5 million for the same period in 2024, indicating a 140% increase [167]. - Research and development expenses decreased to $2.5 million for the three months ended September 30, 2025, from $4.6 million in 2024, a reduction of 46% [169]. - Selling, general and administrative expenses for the three months ended September 30, 2025, were $4.9 million, down from $7.2 million in 2024, a decrease of 32% [171]. - The comprehensive loss attributable to Beyond Air, Inc. for the six months ended September 30, 2025, was $15.5 million, compared to $25.5 million in 2024 [178]. Funding and Financial Outlook - The company expects to incur net losses and cash outflows for at least the next twelve months, indicating a need for additional funding [188]. - The company is required to raise additional funds through equity or debt securities to finance operations until generating sufficient product or royalty revenues [198]. - On November 1, 2024, the company entered into a Loan and Security Agreement for a secured loan with an aggregate principal balance of $11.5 million [190]. - On November 4, 2025, the company entered into a note purchase agreement for a secured promissory note in the principal amount of $12.0 million [194]. - The company has experienced an accumulated loss of $302.0 million since inception through September 30, 2025 [187]. - The net cash used in operating activities for the six months ended September 30, 2025, was $9.0 million, primarily due to a net loss of $16.3 million [180].
Beyond Air® Reports Fiscal Second Quarter 2026 Financial Results and Provides Corporate Update
Globenewswire· 2025-11-10 21:05
Core Insights - Beyond Air, Inc. reported a significant revenue increase of 128% year over year, reaching $1.8 million for the fiscal quarter ended September 30, 2025, compared to $0.8 million for the same period last year [5][10] - The company appointed Bob Goodman as Interim Chief Commercial Officer to lead its commercial strategy following the departure of David Webster [3][5] - Beyond Air raised $12 million in debt financing, resulting in a proforma cash balance of $22.9 million as of September 30, 2025, which is expected to support operations into calendar 2027 [9][16] - The company updated its fiscal year 2026 revenue guidance to a range of $8 million to $10 million [17] Financial Performance - Revenue for the fiscal quarter ended September 30, 2025, was $1.8 million, a 128% increase from $0.8 million in the same quarter of 2024 [10] - Gross loss decreased to $0.3 million for the quarter, down from a gross loss of $1.1 million in the prior year, attributed to sales growth and one-time costs [10][15] - Research and development expenses were $2.5 million, down from $4.6 million in the same quarter of 2024, primarily due to reduced salaries and development costs [11] - Selling, general, and administrative expenses decreased to $4.9 million from $7.2 million year-over-year, reflecting cost management efforts [12] Commercial Strategy and Developments - The company is expanding its global distribution network for LungFit PH, now covering 35 countries with a combined population of 2.8 billion [5] - Beyond Air achieved certification for the Medical Device Single Audit Program (MDSAP), enhancing its compliance across multiple international markets [5] - The U.S. Patent and Trademark Office granted a design patent allowance for the second-generation LungFit PH, extending protection through 2040 [5] Regulatory and Clinical Updates - The company is preparing for regulatory approvals outside the U.S. and anticipates FDA approval for its second-generation LungFit PH by the end of calendar 2026 [4] - The PMA supplement for the second-generation LungFit PH was submitted to the U.S. FDA in June 2025 [14] - The company is advancing clinical trials for its investigational therapies, including BA-101 for Glioblastoma and BA-102 for Phelan-McDermid Syndrome, both of which received Orphan Drug Designation from the FDA [14] Upcoming Events - Beyond Air will participate in the AARC Annual Congress from December 6 to 8, 2025, in Phoenix, AZ [5]
Beyond Air® Secures Up to $32 Million to Accelerate Growth
Globenewswire· 2025-11-05 13:00
Core Viewpoint - Beyond Air, Inc. has secured financing agreements with Streeterville Capital, providing up to $32 million to support its commercial expansion and potential profitability [2][3]. Financing Agreements - The company entered into a $12 million promissory note with a 15% annual interest rate, maturing in 24 months, with no payments due in the first year [3]. - Additionally, a $20 million Equity Line of Credit (ELOC) allows the company to sell newly issued shares over 24 months, with proceeds designated for various corporate purposes [4]. Financial Position - As of September 30, 2025, Beyond Air reported proforma cash and equivalents totaling $22.9 million, which includes the $12 million from the promissory note [1]. Strategic Goals - The financing is aimed at accelerating the commercial expansion of LungFit PH, with expectations of driving sales growth and achieving profitability by the anticipated launch of a second-generation product by the end of 2026 [3]. Company Overview - Beyond Air is focused on developing medical devices and biopharmaceuticals utilizing nitric oxide to treat respiratory illnesses and other conditions [6]. - The company has received FDA approval for its LungFit PH system, which is designed for treating neonates with hypoxic respiratory failure [6][10].
Beyond Air Schedules Second Fiscal Quarter 2026 Financial Results Conference Call and Webcast
Globenewswire· 2025-10-23 12:00
Core Insights - Beyond Air, Inc. will report its financial results for the second fiscal quarter ended September 30, 2025, on November 10, 2025, with a conference call scheduled for 4:30 PM ET on the same day [1] Company Overview - Beyond Air is a commercial-stage medical device and biopharmaceutical company focused on utilizing nitric oxide (NO) to enhance the lives of patients with respiratory illnesses, neurological disorders, and solid tumors [3] - The company has received FDA approval and CE Mark for its first system, LungFit PH, aimed at treating term and near-term neonates with hypoxic respiratory failure [3] - Beyond Air is advancing other LungFit systems in clinical trials for severe lung infections, including viral community-acquired pneumonia and nontuberculous mycobacteria [3] Partnerships and Research Initiatives - The company has partnered with The Hebrew University of Jerusalem to develop a pre-clinical program for treating autism spectrum disorder and other neurological disorders [4] - Beyond Cancer, Ltd., an affiliate of Beyond Air, is exploring ultra-high concentrations of NO with a proprietary delivery system targeting specific solid tumors in pre-clinical studies [4]
Beyond Air registers 719,561 shares for potential resale by warrant holders (NASDAQ:XAIR)
Seeking Alpha· 2025-09-25 21:25
Core Points - The article emphasizes the importance of enabling Javascript and cookies in browsers to prevent access issues [1] - It highlights that users with ad-blockers may face restrictions when trying to access content [1] Summary by Categories Technical Requirements - Users are advised to enable Javascript and cookies in their browsers to ensure proper functionality [1] - The presence of ad-blockers can lead to blocked access, necessitating their disabling for content access [1]
Beyond Air to Participate in the ROTH 4th Annual Healthcare Opportunities Conference
Globenewswire· 2025-09-22 12:00
Core Insights - Beyond Air, Inc. is a commercial-stage medical device and biopharmaceutical company focused on utilizing nitric oxide to enhance patient care [3][4] - The company will participate in the ROTH 4th Annual Healthcare Opportunities Conference on October 9, 2025, where the CFO will be available for investor meetings [1][2] Company Overview - Beyond Air specializes in treatments for respiratory illnesses, neurological disorders, and solid tumors, with FDA approval for its LungFit PH system aimed at neonates with hypoxic respiratory failure [3][4] - The company is advancing other LungFit systems in clinical trials for severe lung infections, including viral pneumonia and nontuberculous mycobacteria [3][4] Product Details - The LungFit system is a cylinder-free, phasic flow generator that delivers nitric oxide at concentrations from 1 ppm to 80 ppm, designed to replace traditional high-pressure NO cylinders [5][6] - LungFit can also deliver NO at concentrations above 80 ppm for treating severe acute lung infections in hospital settings and chronic infections in home settings [6][7] Research Collaborations - Beyond Air has partnered with The Hebrew University of Jerusalem to develop treatments for autism spectrum disorder and other neurological conditions [4] - An affiliate, Beyond Cancer, Ltd., is exploring ultra-high concentrations of nitric oxide for targeting solid tumors in pre-clinical studies [4]
Beyond Air Announces Exercise of Warrants for $3.25 Million of Gross Proceeds
Globenewswire· 2025-09-08 19:55
Core Points - Beyond Air, Inc. has entered into a definitive agreement for the immediate exercise of certain outstanding common warrants to purchase up to 1,439,126 shares at a reduced exercise price of $2.21, expected to generate approximately $3.25 million in gross proceeds [1][3] - Laidlaw & Company (UK) Ltd. is acting as the exclusive placement agent for this offering, which includes the issuance of new unregistered warrants to purchase up to 719,561 shares at a purchase price of $0.0625 per New Warrant [2][4] - The offering is expected to close on or about September 9, 2025, and the net proceeds will be used to advance clinical and pre-clinical programs, as well as for operating expenses and working capital [3][4] Company Overview - Beyond Air is a commercial stage medical device and biopharmaceutical company focused on utilizing nitric oxide to improve the lives of patients with respiratory illnesses, neurological disorders, and solid tumors [6] - The company has received FDA approval for its LungFit® PH system, aimed at treating term and near-term neonates with hypoxic respiratory failure, and is advancing other LungFit systems in clinical trials for severe lung infections [6] - Beyond Air has partnered with The Hebrew University of Jerusalem to develop treatments for Autism Spectrum Disorder and is investigating ultra-high concentrations of nitric oxide for targeting solid tumors in pre-clinical settings [6]
NeuroNOS Granted FDA Orphan Drug Designation for Glioblastoma, the Most Common and Deadliest Primary Malignant Brain Cancer in Adults
Globenewswire· 2025-09-08 12:00
Core Insights - NeuroNOS has received Orphan Drug Designation (ODD) from the FDA for its investigational therapy BA-101 aimed at treating Glioblastoma (GBM) [1][3] - GBM is characterized as an aggressive brain tumor with a median survival of less than 12 months and limited treatment options [2][4] - The company emphasizes the potential of nitric oxide (NO) modulation in improving treatment outcomes for GBM patients [3][4] Company Overview - NeuroNOS focuses on developing therapies for neurological disorders and neuro-oncology, utilizing small molecules to regulate NO levels in the brain [5] - The company has a commitment to advancing medical innovation through collaborations with research institutions and experts [5] - Beyond Air, the parent company of NeuroNOS, is involved in harnessing NO for treating various health conditions, including respiratory illnesses and neurological disorders [6][7] Industry Context - Glioblastoma represents a significant unmet medical need, with current treatments failing to provide curative options [2][4] - Research indicates that dysregulated NO signaling plays a role in GBM biology, suggesting that targeting NO could enhance treatment efficacy [4] - The FDA's ODD provides incentives for developing treatments for rare diseases, including market exclusivity for seven years upon approval [3]