Beyond Air, Inc.

Beyond Air, Inc.

Company overview

Beyond Air, Inc. is a commercial-stage medical device and biopharmaceutical company focused on nitric oxide (NO) generation and delivery technologies through its LungFit platform and related programs.

Core technology and platform

LungFit platform

• Generates NO from ambient air using a patented ionizer-based generator.
• Delivers NO to patients via ventilator circuits, masks, or similar devices.

Key capabilities

• NO generation from ambient air (no high-pressure cylinders required).
• NO delivery up to 400 ppm, with continuous or timed delivery, and dose titration or fixed dosing.
• Real-time monitoring of NO, NO2, and FiO2 in the delivered gas.
• Designed to enable higher concentrations (>100 ppm, including >150 ppm) for antimicrobial effects in certain indications.

Approved product and regulatory status

LungFit PH (first-generation LungFit device)

• FDA: PMA approved in June 2022 for the treatment of persistent pulmonary hypertension of the newborn (PPHN) to improve oxygenation and reduce the need for ECMO in term and near-term neonates (>34 weeks gestation) with hypoxic respiratory failure.
• EU: CE mark obtained in November 2024.
• Indications: NO generation from ambient air, delivered to lungs or ventilator circuits; NO concentration up to 400 ppm; designed to deliver around 20 ppm NO for PPHN (with a range down to 0.5 ppm).

LungFit PH II

• PMA supplement for label expansion to include certain cardiac surgeries was withdrawn in favor of LungFit PH II.
• PMA for LungFit PH II submitted to FDA in June 2025.
• PH II is smaller, lighter, and transport-ready (air and ground transportation), expanding addressable markets.

LungFit PRO and LungFit GO

• LungFit PRO: targeted for viral lung infections, including viral community-acquired pneumonia.
• LungFit GO: NTM lung infection program (NTM COPD context).
• Programs include pilot or early clinical data (e.g., NTM pilot data in Australia; CHEST data in 2022; bronchiolitis pilot programs).

Market footprint

• U.S. commercial launch for LungFit PH began July 2022 (limited launch phase), expanded in 2023.
• CE mark in 2024 enabled entry into >27 countries outside the U.S./EU.
• Distribution agreements cover >40 countries outside the U.S.

Other business lines and programs

Beyond Cancer (majority-owned affiliate, UNO program)

• UNO: ultra-high concentration NO (20,000 – 200,000 ppm) delivered intratumorally for solid tumors.
• Beyond Cancer raised $30.0 million in a private placement in Q4 2021 (80% owned by Beyond Air; 20% to investors).
• Interim and preclinical data presented from 2022–2024; first-in-human Phase 1 started in 2022; ongoing preclinical and combination studies reported at conferences (SITC, AACR, etc.).

NeuroNOS (nNOS inhibitors for neurological conditions)

• June 15, 2023: agreement with Yissum (Hebrew University) to acquire commercial rights to nNOS inhibitors for ASD and other neurological conditions.
• Ownership: Beyond Air 84.75%; NeuroNOS U.S. subsidiary NNOS, Inc. 15.25% equity held by outside investors as of 2025 (per private placements in 2025).
• 2025–2026: Orphan Drug Designations granted by the FDA for BA-102 (ASD) and BA-101 (GBM).

Corporate subsidiaries and affiliates

• BA Ltd. (Israel), Beyond Air Australia, Beyond Air Ireland, and related Irish/Bermuda entities.
• NeuroNOS Ltd. and U.S. subsidiary NNOS, Inc. (84.75%/15.25% ownership split).
• Beyond Cancer Bermuda Limited and related entities (e.g., XAIR Israel, Beyond Cancer U.S.).

Licensing and intellectual property

• NitricGen: global exclusive license for the eNOGenerator and related assets; includes upfront and milestone payments and low single-digit royalties, with ongoing future milestone payments.
• Pulmonox-derived IP: U.S. patents related to NO delivery devices; batch of patents acquired in 2017; subject to milestone and sales-based payments under the Pulmonox agreement.
• More than 40 patent applications worldwide (issued patents and pending applications) covering LungFit, delivery systems, NO generation, NO2 filtration, and related methods.

Commercialization and distribution

• LungFit PH is marketed in the U.S. directly by the company and distributed outside the U.S. via partners.
• Distribution agreements cover more than 40 countries; CE mark provides coverage in 27+ non-U.S./EU markets.

People and employees

• As of March 31, 2026: 54 employees globally (all full-time).

Financial snapshot

• Net loss: $34.3 million for the year ended March 31, 2026; $48.5 million for the year ended March 31, 2025.
• Accumulated deficit: approximately $319.6 million.
• Net cash used in operating activities: approximately $18.1 million for the year ended March 31, 2026.
• Financing and debt: Amended Loan Agreement (Nov 3, 2025) for a $13.5 million secured loan with a mix of cash and part cash interest.
• Balance sheet dynamics emphasize ongoing need for capital to support commercialization, clinical development, and pipeline expansion.

Stock and listing

• Ticker: XAIR (Nasdaq Capital Market).
• April 2026: Nasdaq notified a bid-price deficiency (below $1.00). A hearing was held; as of May 28, 2026, the Nasdaq Panel granted continued listing subject to conditions, including regaining compliance by July 31, 2026 and a one-year discretionary monitoring period.

Strategic position

The company’s strategy centers on the LungFit platform to generate and deliver NO from ambient air to treat hypersensitive pulmonary and infectious conditions, with a focus on PPHN, NTM infections, and severe lung infections in COPD patients. Beyond Air is pursuing international expansion, multiple product candidates, and adjacent biology programs, including UNO for cancer and nNOS inhibitors for neurological conditions.