Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 504

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 504
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. NO has been shown to play a critical role in the function of several body systems. For example, as
vasodilator of smooth muscles, NO enhances blood flow and circulation. In addition, NO is involved in regulation of wound healing and
immune responses to infection. The pharmacology, toxicity and other data for NO in humans is generally well known, and its use has been
approved by the FDA as a vasodilator. The precise effect of inhaled NO is dependent on concentration, oxidation state and type of pathogen.

12

NO has multiple immunoregulatory
and antimicrobial functions that are likely to be of relevance to inhaled NO therapy. In vitro studies suggest that NO possesses
anti-microbial activity against common bacteria, gram positive and gram negative, as well as mycobacteria, fungi, yeast, parasites and
helminths. It has the potential to eliminate multi-drug resistant strains of the above. Anti-viral activity covers respiratory viruses
such as influenza, corona viruses, RSV and others. In healthy humans, NO has been shown to stimulate mucociliary clearance, and low levels
of nasal NO correlate with impaired mucociliary function in the human upper airway. Unlike other inhaled drugs, NO is also a smooth muscle
relaxant and avoids the concomitant bronchial constriction often associated with inhaled antibiotics and mucolytics. A potential benefit
of these multiple mechanisms may be that in addition to treating lung infections in CF patients, this suggests that NO may be useful in
directly treating the mucus caused by CF, which is the principal manifestation of the disease.

Nitric Oxide and Infection

NO possesses broad-spectrum anti-microbial
activity acting against bacteria, fungi and viruses. NO is produced at high output as part of the innate immune response. NO and its by-products
(for example, reactive nitrogen species (“RNS”)) are responsible for the process of killing microorganisms within white blood
cells called macrophages and in organs such as the lungs and other mucolytic tissues.

More than a decade ago, several
research groups showed that NO and RNS possess anti-viral activity and affect several viruses including coxsackievirus, RSV, influenza,
severe acute respiratory syndrome (SARS), coronavirus, rhinovirus, herpes simplex virus, Epstein-Barr virus (EBV), and others. NO has
also been shown to be useful in preventing bacterial growth on surfaces.

Continuous exposure to