Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 503

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 503
---
 will enroll up to 15 subjects with prior exposure to anti-PD-1
antibody that have either progressed, not achieved a response, or have prolonged stable disease (12 weeks) on single agent anti-PD-1 without
radiographic evidence of continued tumor reduction. Subjects enrolled in the Phase 1b trial will be treated with the UNO + anti-PD-1 combination.
Both safety and efficacy will be evaluated. Completion of enrollment is anticipated by the end of calendar 2025.

Selective neuronal nitric oxide synthase (nNOS)
inhibitor for the treatment of neurological conditions in collaboration with Hebrew University of Jerusalem

On June 15, 2023, we announced
that we had entered into an agreement with Yissum Research Development Company of the Hebrew University of Jerusalem, LTD. (the “University”)
to acquire the commercial rights for neuronal nitric oxide synthase (nNOS) inhibitors being developed for the treatment of autism spectrum
disorder (“ASD”) and other neurological conditions. Currently, there are no FDA-approved therapies utilizing nNOS inhibitors
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 two-year period from the date of the agreement. Also, we will pay a low single-digit royalty on net sales and certain one-time
payments based on clinical, regulatory and sales milestones.

In the first
calendar quarter of 2025, NeuroNos, our majority-owned affiliate, raised $2.0 million in a private placement of common shares. The
investors purchased a 11.8% equity ownership in NeuroNos, while Beyond Air maintained 88.2% equity ownership. The private placement
remains open to investment at this time. The funding is being used to accelerate ongoing preclinical work, including IND-enabling studies as well as for general corporate purposes.

Work is currently being done by the University in
a preclinical setting. We expect this program to progress from preclinical to a phase 1 first-in-human clinical trial by the end of 2026.

Background and NO Mechanism of Action

NO is recognized as a vital molecule
involved in many physiological and pathological processes. NO is naturally produced by the body’s immune system to provide a first
line of defense against invading pathogens. It is a powerful molecule with a short half-life of a few seconds in the blood, enabling it
to be cleared rapidly from the body