Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 897

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1A
Chunk 897
---
 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.

LungFit® can
be used to treat patients on ventilators that require NO, as well as patients with chronic or acute severe lung infections via
delivery of NO at concentrations > 100 parts per million (ppm) through a breathing mask or similar apparatus. Furthermore, we
believe that there is a high unmet medical need for patients suffering from certain severe lung infections that the
LungFit® platform can potentially address. The Company’s other areas of focus with the LungFit® platform
beyond PPHN are nontuberculous mycobacteria (“NTM”) lung infection and those with various severe lung infections with
underlying chronic obstructive pulmonary disease (“COPD”). Our current product candidates will be subject to premarket
reviews and approvals by the FDA, certification through the conduct of a conformity assessment by a notified body in the EU for the
product to be CE marked, as well as comparable foreign regulatory authorities.

With
Beyond Air’s focus on NO and its effect on the human condition, the Company has two additional programs that do not utilize the
LungFit® system. Through the Company’s majority-owned affiliate Beyond Cancer, Ltd. (“Beyond Cancer”)
NO is used to target solid tumors. The LungFit® platform is not utilized for the solid tumor indication due to the need
for ultra-high concentrations of gaseous nitric oxide (“UNO”). A proprietary delivery system has been developed that is designed
to safely deliver UNO in excess of 10,000 ppm directly to a solid tumor. This program has advanced to a phase 1 human clinical trial.

On
November 4, 2021, Beyond Air reorganized its oncology business into a new private company called Beyond Cancer. Beyond Air’s preclinical
oncology team and the exclusive right to the intellectual property portfolio utilizing UNO for the treatment of solid tumors now reside
with Beyond Cancer. Beyond Air has 80% ownership in Beyond Cancer.

The
second program which does not utilize the LungFit® platform partially inhibits neuronal nitric oxide synthase (