On November 10, 2025 Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company"), a commercial stage medical device and biopharmaceutical company focused on harnessing the power of nitric oxide (NO) to improve the lives of patients, reported its financial results for fiscal second quarter ended September 30, 2025, and provided a corporate update.
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"Over the past year, we have made steady progress deploying LungFit PH to hospitals across the U.S. and establishing a global distribution network. As the first and only FDA-approved tankless nitric oxide generator and delivery system that uses ambient air to produce nitric oxide on demand for hospital use, LungFit PH is delivering meaningful workflow and efficiency benefits for clinicians and hospital administrators. With the recent capital infusion, we plan to accelerate commercial execution and advance regulatory initiatives, including select international submissions and our second-generation LungFit PH. We also welcome Beyond Air Board member Bob Goodman as Interim Chief Commercial Officer to lead our commercial strategy and team transitioning from David Webster, who leaves us with our gratitude. Bob brings decades of commercial leadership across medtech and pharma, including senior roles at BioTelemetry and Philips Healthcare, and will oversee U.S. and international commercial strategy, team expansion, and channel optimization," said Steve Lisi, Chairman and Chief Executive Officer.
We are gearing up for regulatory approvals outside the US as well as the anticipated FDA approval of our second generation LungFit PH and subsequent launch before the end of calendar 2026, subject to regulatory review and clearance," concluded Mr. Lisi.
Commercial Execution, Recent Highlights and Upcoming Milestones
LungFit PH Commercial Execution
Revenue increased 128% to $1.8 million for the fiscal quarter ended September 30, 2025, compared to $0.8 million for the same period last year. Growth was driven by increased demand for LungFit PH through U.S. commercial activities.
International revenue continues to build momentum, driven by recent regulatory approvals in select markets. During the quarter, the Company expanded its global LungFit PH distribution network, including new agreements in Japan, South Korea, Costa Rica, Guatemala, Panama, and El Salvador, bringing its total international coverage to 35 countries, representing a combined population of 2.8 billion people.
Appointed Robert (Bob) Goodman interim Chief Commercial Officer following the departure of David Webster. Robert, who joined the Board of Beyond Air in June 2025, has held key leadership roles at a range of high-performing organizations, including BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific, and Pfizer. His career spans public companies, private equity-backed businesses, and early-stage ventures, where he has consistently driven innovation, operational scale, and commercial success.
U.S. Patent and Trademark Office granted a patent allowance for a design patent covering the second-generation LungFit PH through 2040.
Achieves certification to demonstrate conformity of its Quality Management System with the regulatory requirements of all MDSAP participating countries, that include Australia, Brazil, Canada, European Union, Japan and United States.
The Beyond Air team will be attending the AARC Annual Congress, which is taking place December 6th to 8th in Phoenix, AZ.
Pending Regulatory Milestones
PMA supplement for the second-generation LungFit PH submitted to U.S. FDA in June 2025.
International submissions for LungFit PH remain on track with local partners.
Beyond Cancer – Solid Tumor Program – clinical stage development of an intratumoral ultra-high concentration Nitric Oxide (UNO) technology as a gas delivery of NO at high concentrations to tumors to induce an immune response.
Clinical Development Execution
Phase 1a trial (monotherapy) – Part A of the trial evaluating UNO therapy in 10 subjects with advanced, relapsed or refractory unresectable, primary or metastatic cutaneous and subcutaneous solid tumors at a dose of 25,000 ppm has been completed.
Latest results to date from the Phase 1a trial show median overall survival (mOS) has not yet been achieved, with median survival expected to exceed 23 months.
Phase 1b trial (combination therapy) – Will assess the intratumoral administration of 25,000 ppm low volume (LV) Nitric Oxide (UNO) in subjects with unresectable cutaneous or subcutaneous histologically confirmed primary or metastatic lesions, who have shown disease progression or prolonged stable disease (12 weeks) after receiving a single agent anti-PD-1 containing treatment.
NeuroNOS – Autism Spectrum Disorder (ASD) Program – developing neuronal nitric oxide synthase (nNOS) inhibitors for the treatment of autism spectrum disorder ("ASD") and other neurological conditions.
U.S. FDA granted Orphan Drug Designation to its investigational therapy, BA-101, for the treatment of Glioblastoma (GBM). The Company is working closely with regulators, investigators, patient groups, and foundations to accelerate development of BA-101 toward first-in-human studies.
U.S. FDA granted Orphan Drug Designation to BA-102, an investigational therapy for the treatment of Phelan-McDermid Syndrome (PMS), a syndrome associated with ASD. The Company is in preclinical development and expects to progress to a Phase 1 first-in-human clinical trial by the end of 2026, which could provide data in 2027.
Financing & Liquidity
Closed a promissory note and equity line of credit for up to $32 million with Streeterville Capital, LLC. The agreement provides Beyond Air with a debt agreement for $12.0 million, which does not require any payment for the first year, as well as an equity line of credit for up to $20 million, which is subject to an effective registration statement and other customary conditions. This infusion of new capital equates to a September 30, 2025 proforma cash, cash equivalents, restricted cash and marketable securities balance of $22.9 million, which is expected to provide runway into calendar 2027.
Financial Results for the Fiscal Quarter Ended September 30, 2025
Revenues for the fiscal quarter ended September 30, 2025 increased 128% to $1.8 million, compared with $0.8 million for the fiscal quarter ended September 30, 2024. Gross loss of $0.3 million was recognized for the quarter ended September 30, 2025, compared with a gross loss of $1.1 million for the quarter ended September 30, 2024. The decrease in gross loss was primarily attributed to sales growth, partially offset by one-time costs required to upgrade the Company’s existing fleet of devices and provisions for excess inventory.
Research and development expenses for the fiscal quarter ended September 30, 2025 were $2.5 million compared with $4.6 million for the fiscal quarter ended September 30, 2024. The decrease of $2.1 million was primarily attributed to a decrease in salaries, stock-based compensation costs and a reduction in Gen II device development costs.
Selling, general and administrative expenses for the quarters ended September 30, 2025 and September 30, 2024 were $4.9 million and $7.2 million, respectively. The decrease of $2.3 million was primarily attributed to a reduction in salaries and stock-based compensation costs.
Other expense for the quarter ended September 30, 2025 was $0.6 million compared with other expense of $1.2 million for the quarter ended September 30, 2024. The decrease in expense of $0.6 million was primarily attributed to the prior period loss associated with the partial extinguishment of debt.
Net loss attributed to common stockholders of Beyond Air, Inc. for the quarter ended September 30, 2025 was ($7.9) million or a loss of ($1.25) per share, basic and diluted, compared to a net loss attributed to common stockholders of Beyond Air, Inc. for the fiscal quarter ended September 30, 2024 of ($13.4) million or a loss of ($5.67) per share, basic and diluted.
Net cash burn in the fiscal quarter ended September 30, 2025 was $4.7 million.
As of September 30, 2025, the Company reported cash, cash equivalents, and marketable securities of $10.7 million, and total long-term debt outstanding was $10.1 million. An additional $2.1 million related to an insider loan was recorded as long term liabilities pending finalization of terms. Synthetic royalty related debt repayment does not begin until October 2026. Subsequent to the end of the quarter, the Company secured up to $32 million in capital through a new promissory note and equity line of credit. The new $12 million note bears a 15% interest rate and matures in 24 months, with no payments due during the first 12 months.
Financial Guidance for Fiscal Year 2026
The Company updated its revenue guidance to $8 to $10 million for the fiscal year ending March 31, 2026.
Conference Call & Webcast
Monday, November 10th @ 4:30 PM ET
Domestic: 1-877-407-0784
International: 1-201-689-8560
Conference ID: 13756730
Webcast: A webcast of the live conference call can be accessed by visiting the Events section of the Company’s website (click here) or directly (click here). An online replay will be available on the Company’s website or via the direct link an hour after the call.
(Press release, Beyond Air, NOV 10, 2025, View Source [SID1234659739])