Company: XAIR
Filing Date: 2025-02-10
Form Type: 10-Q
Source: 0001493152-25-005678
Chunk: 58

Company: Beyond Air, Inc.
Filing Date: 2025-02-10
Form: 10-Q
Item: Part I, Item 1
Chunk 58
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) representing 20% to 25% of all NTM
and other forms of NTM that are refractory to antibiotic therapy, frequently require lengthy and repeated hospital stays to manage
their condition. There are no treatments specifically indicated for the treatment of M. Abscessus lung disease in North America,
Europe or Japan.

Current
estimates place the number of people with NTM infections in the U.S as high as 220,000. It is estimated that in Asia, the number of patients
suffering from NTM surpasses what is seen in the U.S. There is one inhaled antibiotic approved for the treatment of refractory Mycobacterium
avium complex (“MAC”). Current guideline-based approaches to treat NTM lung disease involve multi-drug regimens of antibiotics
that may cause severe, long lasting side effects, and treatment can be longer than 18 months. Median survival for NTM MAC patients is
approximately 13 years while median survival for patients with other variations of NTM is typically 4.6 years. The prevalence of human
disease attributable to NTM has increased over the past two decades. In a clinical trial conducted between 2007 and 2016, researchers
found that the prevalence of NTM in the U.S. is increasing at approximately 7.5% per year. M. abscessus treatment costs are estimated
to be more than double that of MAC. A 2015 publication by co-authors from several U.S. government departments stated that cases in 2014
alone cost the U.S. healthcare system approximately $1.7 billion. For this indication, we believe U.S. sales potential to be greater
than $1 billion and worldwide sales potential to be greater than $2.5 billion.

In
December 2020 we began a 12-week, multi-center, open-label clinical trial in Australia intended to enroll approximately 20 adult patients
with chronic refractory NTM lung disease. We received a grant of up to $2.17 million from the Cystic Fibrosis Foundation (“CFF”)
to fund this clinical trial and advance the clinical development of inhaled NO to treat NTM pulmonary disease. The trial enrolled both
cystic fibrosis (“CF”) and non-CF patients infected with MAC, M. abscessus or any strain of NTM. The clinical trial
consisted of a run-in period followed by two treatment phases. The run-in period provided a baseline for the efficacy endpoints