Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 517

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 517
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o toxicology study of intermittent with LungFit® NO at 200 – 400 ppm showed a non-genotoxic response at all concentrations

Additional Programs

Beyond Cancer’s research
data has shown that UNO has anticancer properties and elicits an immune response from the host. Beyond Cancer utilizes an intratumoral
UNO technology as a gas delivery of NO at high concentrations to tumors to induce an immune response. Gas based intratumoral therapies
for the treatment of cancer are considered novel and new medical science. Beyond Cancer’s efforts are currently also focused on
utilizing UNO in combination with Keytruda, a PD-1 inhibitor or other PD-1 or PDL-1 inhibitors as a treatment for cancers. To date, no
such gas-based therapy has been approved for commercialization by the FDA or other regulatory agencies.

NeuroNos has entered into an agreement
with Yissum Research Development Company of the Hebrew University of Jerusalem, LTD. 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 currently no FDA approved therapies utilizing nNOS inhibitors specifically for the treatment of ASD.

Competition

The biotechnology, pharmaceutical
and medical device industries are highly competitive. There are many pharmaceutical companies, biotechnology companies, medical device
companies, public and private universities and research organizations actively engaged in the research and development (“R&D”)
of products that may be similar to our approved product or product candidates. We are aware of several companies currently developing
and selling NO therapies for various indications such as hypoxic respiratory failure (HRF). For example, Mallinckrodt commercializes INOMAX®
(nitric oxide) for inhalation, which is approved for use to treat newborns suffering from hypoxic respiratory failure (“HRF”)-PPHN,
in the U.S., Canada, Australia, Mexico and Japan. Linde Group markets a generic version of the Mallinckrodt offering with their delivery
system called NOxBOX®. The Linde Group has marketing rights to INOMAX® in Europe. Air Liquide sells a similar
product in Europe, called KINOX™, together with their delivery platform called SoKINOX™, for the treatment of pulmonary hypertension
of the newborn. In Europe, EKU, International Biomedical, Cahouet and ITC each have a device that delivers nitric oxide