Beyond Air® Reports Q3 2025 Financial Results and Corporate Developments

Beyond Air, Inc., 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 the fiscal third quarter ended December 31, 2024, and provided a corporate update.

“Our commercial team continues to make significant progress as we expand the number of U.S. hospitals utilizing LungFit PH. While this is the culmination of years of work, it was approximately nine months ago that we started to make significant headway in our commercial efforts with the fully updated system. We expect to continue generating double digit sequential quarterly revenue growth for the foreseeable future,” said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air.

“We ended calendar year 2024 on a high note with the receipt of CE Mark for LungFit PH in Europe, opening a significant portion of the global market outside of the U.S. for our current and future distribution partners to launch their commercial programs for LungFit PH. With the advantage of real-world customer experience and feedback from our U.S. program, combined with our distribution partners’ established sales teams and customer networks, we anticipate a faster commercial ramp-up in these regions compared to what we experienced in the U.S.,” concluded Mr. Lisi.

Commercial Execution, Portfolio Highlights and Upcoming Milestones

• LungFit® PH Commercial Execution
  • Increased demand for LungFit PH:
    • A 34% increase in revenue for the quarter ended December 31, 2024, compared with the quarter ended September 30, 2024
    • Six new hospital starts in the U.S. in the quarter ended December 31, 2024
  • Received market authorization in Australia in January 2025 and expect to have regulatory approvals in eight countries covered under the partnership with Getz Healthcare by calendar year-end, with initial commercial shipments occurring in 2025.
  • Signed partnerships with two distributors in the Middle East in January 2025, with initial shipments expected in the 1H of calendar year 2025.

• Pipeline Highlights
  • Received CE Mark for LungFit PH, which allows Beyond Air to market LungFit PH in the European Union and all other countries that recognize this certification.
    • Indications under CE Mark certification include:
      • The treatment of infants >34 weeks gestation with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation; and
      • The treatment of peri- and post-operative pulmonary hypertension in adults and newborn infants, infants and toddlers, children and adolescents, ages 0-17 years in conjunction to heart surgery, in order to selectively decrease pulmonary arterial pressure and improve right ventricular function
    • CE Mark certification triggered a $1 million milestone payment, payable in the fiscal fourth quarter of 2025, from the Company’s Asia-Pacific partner, Getz Healthcare, the leading distributor of medical equipment, devices and consumables in Asia Pacific region – providing access to hospitals in Australia, New Zealand, Thailand, Philippines, Taiwan, Hong Kong, Malaysia, Pakistan, Singapore and Vietnam
      • Beyond Air will also receive double-digit royalty payments based on LungFit PH net sales by Getz Healthcare
  • Cardiac surgery PMA supplement review ongoing at FDA
    • Currently no FDA approved nitric oxide system is labeled for cardiac surgery
    • Approval should increase LungFit PH’s rate of market penetration
  • LungFit PH transport-ready PMA supplement submission to FDA anticipated in the coming months

Beyond Cancer - Solid Tumor Program

• Clinical Development Execution
  • Phase 1a trial (monotherapy) - Part A of the trial evaluating ultra-high concentration Nitric Oxide (UNO) therapy in 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, and at the dose of 50,000 ppm is ongoing.
  • Phase 1b trial (combination therapy) - Received regulatory approval in Israel for Part B of the trial, which will assess the intratumoral administration of 25,000 ppm low volume (LV) Nitric Oxide (UNO) in patients 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. Topline data from the Phase 1b portion of the study are anticipated late in calendar 2025 or early-2026.

NeuroNOS – Autism Spectrum Disorder (ASD) Program

• NeuroNOS appointed Professor Roger D. Kornberg to its Scientific Advisory Board (SAB). Dr. Kornberg was awarded the Nobel Prize in Chemistry in 2006 for his groundbreaking work in molecular biology and is a renowned leader in the field of eukaryotic gene transcription. Professor Kornberg will assist NeuroNOS in accelerating the development of treatments for ASD and potentially other neurological disorders.

Financial Results for the Fiscal Third Quarter Ended December 31, 2024

Revenues for the fiscal quarter ended December 31, 2024 were $1.1 million compared to $0.4 million for the fiscal quarter ended December 31, 2023 and $0.8 million for the previous quarter ended September 30, 2024.

Cost of revenue of $1.3 million was recognized for the three months ended December 31, 2024, compared to $0.7 million for the three months ended December 31, 2023. Cost of revenue exceeded revenue primarily driven by depreciation of LungFit devices and one-time upgrade costs to systems.

Research and development expenses for the three months ended December 31, 2024 were $3.0 million as compared to $6.8 million for the three months ended December 31, 2023. The decrease of $3.8 million was primarily attributed to a decrease in salaries, stock-based compensation and to a lesser extent from clinical and pre-clinical studies expenses.

Selling, general and administrative expenses for the three-month periods ended December 31, 2024 and 2023 were $7.7 million and $9.8 million, respectively. The decrease of $2.1 million was attributed primarily to a reduction in salaries and stock-based compensation cost.

Other expense for the three months ended December 31, 2024 was $2.4 million compared to $0.3 million for the three months ended December 31, 2023. The increase in other expense of $2.1 million was mainly due to a non-cash loss recorded upon the retirement of the Avenue Capital debt.

Cash burn in the fiscal quarter ended December 31, 2024, excluding the impacts of financing and the extinguishment of debt, was $7.6 million.

As of December 31, 2024, the Company reported cash, cash equivalents, and marketable securities of $10.9 million, and total debt outstanding of $11.8 million. Debt repayment does not begin until October 2026. The Company’s cash, cash equivalents, and marketable securities, along with its cash conservation strategy and anticipated revenue growth are expected to provide sufficient cash runway to support current operating plans well into calendar 2026.