Company: XAIR
Filing Date: 2025-06-20
Form Type: 10-K
Source: 0001641172-25-015750
Chunk: 498

Company: Beyond Air, Inc.
Filing Date: 2025-06-20
Form: 10-K
Item: Item 1
Chunk 498
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actory 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. 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