Full Press Release Details
Air Reports Fiscal Second Quarter 2026 Financial Results and Provides Corporate Update
revenue by 128% year over year (YoY) to $1.8 million
Beyond Air Board member Bob Goodman as Interim Chief Commercial Officer
$12.0 million in debt financing; proforma cash, cash equivalents, restricted cash and marketable securities of $22.9 million as of September
certificate for Medical Device Single Audit Program (MDSAP)
fiscal year 2026 revenue guidance to $8 - $10 million
call at 4:30 p.m. ET today, November 10th
City, NY, 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, today announced its financial results for fiscal second quarter ended September 30, 2025, and provided a corporate update.
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.
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.
Execution, Recent Highlights and Upcoming Milestones
| 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 6 th to 8th in Phoenix, AZ. |
| 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. |
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.
- 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. |
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.
Results for the Fiscal Quarter Ended September 30, 2025
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.
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.
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.
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
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.
cash burn in the fiscal quarter ended September 30, 2025 was $4.7 million.
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.
Guidance for Fiscal Year 2026
Company updated its revenue guidance to $8 to $10 million for the fiscal year ending March 31, 2026.
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. |
Air is a commercial-stage medical device and biopharmaceutical company dedicated to harnessing the power of endogenous and exogenous
nitric oxide (NO) to improve the lives of patients suffering from respiratory illnesses, neurological disorders, and solid tumors. The
Company has received FDA approval and CE Mark for its first system, LungFit PH, for the treatment of term and near-term neonates with
hypoxic respiratory failure. Beyond Air is currently advancing its other revolutionary LungFit systems in clinical trials for the treatment
of severe lung infections such as viral community-acquired pneumonia (including COVID-19) and nontuberculous mycobacteria (NTM).
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. Additionally, Beyond Cancer, Ltd., an affiliate of Beyond Air, is investigating
ultra-high concentrations of NO with a proprietary delivery system to target certain solid tumors in the pre-clinical setting. For more
information, visit www.beyondair.net.
Air's LungFit is a cylinder-free, phasic flow generator and delivery system designated as a medical device by the U.S. Food and
Drug Administration (FDA). The ventilator-compatible version of the device can generate NO from ambient air on demand for delivery to
the lungs at concentrations ranging from 1 ppm to 80 ppm. The LungFit system could potentially replace large, high-pressure NO cylinders,
providing significant advantages in the hospital setting, including greatly reducing inventory and storage requirements, improving overall
safety by eliminating NO2 purging steps, and offering other operational benefits.
can also deliver NO at concentrations at or above 80 ppm for potentially treating severe acute lung infections in the hospital setting
(e.g., COVID-19, bronchiolitis) and chronic, refractory lung infections in the home setting (e.g., NTM). With the elimination of cylinders,
Beyond Air intends to offer NO treatment in the home setting.
Air's LungFit PH is approved for commercial use in the United States, European Union, and many other countries around the world.
Beyond Air's other LungFit systems are not approved for commercial use and are for investigational use only. Beyond Air is not
suggesting NO use over 80 ppm or use at home.
pulmonary hypertension of the newborn (PPHN) is a lethal condition and secondary to failure of normal circulatory transition at birth.
It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased pulmonary
blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1,000 live births (0.4-6.8/1000 live
births) with mortality rate ranging between 4-33%. This syndrome complicates the course of about 10% of infants with respiratory
failure and remains a source of considerable morbidity and mortality. NO gas is a vasodilator, is approved in dozens of countries to
improve oxygenation and reduces the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation)
neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction
with ventilator support and other appropriate agents.
Cancer, Ltd., an affiliate of Beyond Air, Inc., is a development-stage biopharmaceutical and medical device company utilizing (UNO via
a proprietary delivery platform to treat primary tumors and prevent metastatic disease. Nitric oxide at ultra-high concentrations has
been reported to show anticancer properties and to potentially serve as a chemosensitizer and radiotherapy enhancer. A first-in-human
study is underway in subjects with solid tumors. The Company is conducting preclinical studies of UNO in multiple solid tumor models
to inform additional treatment protocols. For more information, visit www.beyondcancer.com.
is at the forefront of developing innovative treatments for neurodevelopmental and neurodegenerative disorders. The company specializes
in creating therapies based on small molecules that cross the blood-brain barrier to regulate Nitric Oxide (NO) levels in the brain.
Preclinical studies conducted by NeuroNOS have demonstrated that NO is present at elevated levels in children with Autism Spectrum Disorder
(ASD) and adults suffering from brain-related diseases such as Alzheimer's and brain cancers. The company's research has
shown that managing NO levels in the brain is crucial for maintaining normal brain function. By leveraging this groundbreaking science,
NeuroNOS aims to bring transformative therapies to those affected by these challenging conditions, ultimately improving individuals'
lives. Through collaborations with leading research institutions and experts in the field, the company is committed to advancing medical
innovation and delivering life-changing treatments. For more information, please visit https://www.neuro-nos.com.
press release contains "forward-looking statements" concerning the potential safety and efficacy of inhaled nitric oxide