Company: XAIR
Filing Date: 2025-08-12
Form Type: 10-Q
Source: 0001641172-25-023243
Chunk: 103

Company: Beyond Air, Inc.
Filing Date: 2025-08-12
Form: 10-Q
Item: Part II, Item 8
Chunk 103
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 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. The
first treatment phase took place over a two-week period and began in the hospital setting where patients were titrated from 150 ppm NO
up to 250 ppm NO over several days. During this phase patients received NO for 40 minutes, four times per day while Methemoglobin (“MetHb”)
levels were monitored. Patients were also trained to use LungFit® GO and subsequently discharged to complete the remaining
portion of the two-week treatment period at their home at the highest tolerated NO concentration. For the second treatment phase, a 10-week
maintenance phase, the administration was twice daily. The clinical trial evaluated safety, quality of life, physical function, and bacterial
load among other parameters.

At
the American Thoracic Society International Conference 2022 (ATS 2022), we presented positive interim data from the ongoing clinical
trial. At the time of data cutoff on April 4, 2022,