Beyond Air(US:XAIR)2019-03-21 16:26AIT Therapeutics Overview - AIT Therapeutics is a medical device company developing a Nitric Oxide generator system for various respiratory conditions[16, 194] - The company's proprietary technology generates NO from ambient air, eliminating the need for cylinders and potentially enabling home use[16, 124, 194] - AIT's Nitric Oxide Delivery System has demonstrated a safety record at a concentration of 160 ppm NO, with over 2,100 treatments in over 85 patients across 7 studies and no Serious Adverse Events (SAEs) related to NO therapy[16, 91, 92, 194] Target Indications and Market Potential - Pulmonary Hypertension (in-hospital): US sales potential >$300 million, worldwide sales potential >$600 million, with a planned launch in 2020[16, 155, 194] - Bronchiolitis (in-hospital): US sales potential >$500 million, worldwide sales potential >$12 billion, with a planned launch in 2021[16, 96, 155, 194] - Severe Lung Infections (at-home): US sales potential >$1 billion, worldwide sales potential >$25 billion, with a planned launch in 2023, initially targeting NTM abscessus (MABSC)[16, 126, 148, 155, 194] AirNOvent Platform and Partnership - AirNOvent is AIT's cylinder-free Nitric Oxide therapeutic platform for pulmonary hypertension treatment in the hospital setting[45, 52] - AIT has a partnership with Circassia Pharmaceuticals, with potential milestones of $3255 million and royalties of 15-20% on gross profit[78, 88] - AIT anticipates PMA filing with the FDA in the Second Quarter of 2019 and US commercial launch planned for the First Half of 2020[88] Financial Status - As of February 1, 2019, AIT had $13 million in cash and $0 in debt, with an expected monthly burn rate of $600,000-$650,000[176]