Company: XAIR
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001641172-25-023243
Chunk: 68

Company: Beyond Air, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Part II, Item 8
Chunk 68
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 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. 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 (nNOS) in the brain
to treat neurological conditions. The first target indication is autism spectrum disorder (“ASD”). On June 15, 2023, the
Company announced that it has entered into an agreement with Yissum Research Development Company of the Hebrew University of Jerusalem,
LTD. (the “University”) to acquire the commercial rights for nNOS inhibitors being developed for the treatment of ASD and
other neurological conditions. Currently, there are no FDA-approved therapies specifically for the treatment of ASD. Under the terms
of the