Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 518

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 518
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. Bellerophon Therapeutics
is developing an NO delivery system for patients with chronic pulmonary diseases such as COPD, PH-sarcoidosis, or fibrotic interstitial
lung disease. VERO Biotech LLC received FDA approval for their delivery system GENOSYL DS for HRF associated with PPHN in 2019, and received
FDA approval for a third generation of that delivery system in 2023. In addition, other companies may be developing inhaled NO delivery
systems at various concentrations. Novan Inc. has recently received approval for a nitric oxide-based prescription treatment called berdazimer
for molluscum, a contagious skin infection. SaNOtize has an NO nasal spray that has received approval in India, Israel and eight other
countries for preventing COVID-19 after exposure. Third Pole has reported the development of an NO generator and delivery system, but
we are not aware of any display of any product at any medical/scientific conference in recent years. Our patents surrounding LungFit®
have priority date over those of Third Pole. NovLead Biotechnology (Nanjing, China) has a device that produces NO through a process
of passing an electric current through an electrolyte solution and Shenzhen Respomed Medical Technology (Shenzhen, China) has developed
a machine that uses an electric charge to generate nitric oxide. Neither of these devices have approval outside of China.

Some of our competitors, either
alone or through their strategic partners, might have substantially greater name recognition and financial, technical, manufacturing,
marketing and human resources than we do and greater experience and infrastructure in the research and clinical development of pharmaceutical
products, obtaining FDA and other regulatory approvals of those products and commercializing those products around the world.

As it relates to Beyond Cancer’s
programs, no such gas-based therapies have been approved for commercialization by the FDA or other regulatory agencies to date. Similarly,
as it relates to NeuroNos, there are currently no FDA approved therapies utilizing nNOS inhibitors specifically for the treatment of ASD.

19

Manufacturing and Distribution

We have contracted with third-party
contract manufacturers, Spartronics LLC (“Spartronics”), and Medisize Ireland Limited (“Medisize”) who have completed
a substantial portion of the commercial manufacturing process for our LungFit® PH system. In addition, we will be reliant
on our partners for commercial manufacture of our systems for both clinical studies and commercial supply. In the year ended March 31,
2025, the