Company: XAIR
Filing Date: 2025-02-10
Form Type: 10-Q
Source: 0001493152-25-005678
Chunk: 52

Company: Beyond Air, Inc.
Filing Date: 2025-02-10
Form: 10-Q
Item: Part I, Item 1
Chunk 52
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,000 ppm directly to a solid tumor. This program has advanced to phase 1 clinical trials.

On
November 4, 2021, we reorganized our oncology business into a new private company called Beyond Cancer. Our 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”). ASD is a
serious neurodevelopmental and behavioral disorder, and one of the most disabling conditions and chronic illnesses in children. ASD includes
a wide range of developmental disorders that share a core of neurobehavioral deficits manifested by abnormalities in social interactions,
deficits in communication, restricted interests, and repetitive behaviors. In 2023, the CDC reported that approximately 1 in 36 children
in the U.S. is diagnosed with an ASD. The cost of caring for Americans with autism had reached $268 billion in 2015 and would rise to
$461 billion by 2025 in the absence of more-effective interventions and support across the life span. We expect this program to progress
from preclinical to a phase 1 first-in-human clinical trial in 2026. Beyond Air has formed a wholly owned subsidiary called NeuroNOS
which is responsible for pre-clinical and clinical development.

LungFit® PH
is the first FDA-approved and CE Mark system using our patented plasma pulse technology to generate on-demand NO from ambient air
and, regardless of dose or flow, deliver it to a ventilator circuit. The device uses a medical air compressor to drive room air
through a plasma chamber in the center of the unit where pulses of electrical discharge are created between two electrodes. The
system uses the power equivalent to a 60-watt lightbulb to ionize the nitrogen and oxygen molecules, which then combine as NO with
low levels of nitrogen dioxide (“NO2”) created as a byproduct. The products are then passed through a Smart
Filter, which removes the toxic NO2 from the internal circuit. With respect to PPHN, the novel LungFit® PH
is designed to deliver a dosage of NO to the lungs that is consistent with current guidelines for delivery of 20 ppm NO with a range