Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 491

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 491
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ontuberculous 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, there are two additional programs that do not utilize our LungFit® system.
Through our majority-owned affiliate Beyond Cancer Bermuda Limited (“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 is currently in phase 1 clinical trials.

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 agreement, Beyond Air shall pay to the
University compensation for pre-clinical work over the three-year period from the date of the agreement. Also, the Company will pay to
the University a low single-digit royalty on net sales and certain one-time payments based on clinical, regulatory and sales milestones.
The Company expects this program to progress from preclinical to a phase 1 first-in-human clinical trial by the end of 2026.

On March 24, 2025,