Company: XAIR
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001641172-25-023243
Chunk: 56

Company: Beyond Air, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Part I, Item 1
Chunk 56
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 increase in the M1/M2 ratio. Myeloid Derived Suppressor Cells (MDSCs) also showed a 54%
decrease. In the 25,000 ppm cohort, the same stimulatory immune biomarkers were upregulated. UNO was generally well tolerated with primarily
Grade 1 related toxicities. One Grade 3 adverse event was deemed a dose limiting toxicity in the 50,000 ppm cohort resulting in the expansion
of the cohort to six total subjects.

The
Company also reported a case of relapsed/refractory Triple Negative Breast Cancer (TNBC) in which the subject showed no evidence of malignancy
in a satellite lesion 21 days following UNO treatment and a corollary, rapid and durable clinical resolution of radiation-induced dermatitis.

A
Phase 1b trial protocol was approved by the Israeli Ministry of Health (IMOH) in December 2024. This trial 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. Timing of the initiation of the study is under review.

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.