
Company Overview - Beyond Air's LungFit™ devices generate nitric oxide (NO) from ambient air, offering on-site generation compared to fixed cylinder systems[8] - The company is developing NO therapies for various lung infections, including acute viral pneumonia, bronchiolitis, and nontuberculous mycobacteria (NTM)[8] - Beyond Air is also in preclinical development of ultra-high concentration (10,000+ ppm) NO for solid tumors[8] - The company anticipates a US launch of LungFit™ PH in 2Q21 for in-hospital use for PPHN and cardiac surgery, with CE Mark expected in 2H21[11] Market Potential - The US sales potential for in-hospital use for PPHN and cardiac surgery is estimated to be >$300 million, with a worldwide sales potential of >$600 million[16] - The US sales potential for acute viral pneumonia (including COVID-19) is estimated to be >$1.5 billion, with a worldwide sales potential of >$3 billion (excluding pandemic)[16] - The US sales potential for bronchiolitis is estimated to be >$500 million, with a worldwide sales potential of >$1.2 billion[16] - The US sales potential for nontuberculous mycobacteria (NTM) lung infection is estimated to be >$1 billion, with a worldwide sales potential of >$2.5 billion[17] - The potential market for severe exacerbations due to lung infections in COPD patients is estimated to be >$2.5 billion in the US and >$6 billion worldwide[19] Clinical Data and Safety - Pilot studies with high concentration NO (up to 250 ppm) have shown no serious adverse events (SAEs) in humans[52] - A 2019-2020 pilot study in bronchiolitis (n=89) showed statistically significant improvements with 150 ppm treatment compared to 85 ppm and control[51] - In a pilot study with NTM infected CF patients, bacterial load was reduced by 65% at day 81 versus baseline with 160 ppm NO[96] Financial Information - As of September 30, 2020, Beyond Air had $22.4 million in cash and cash equivalents and $5 million in debt[109] - The expected quarterly burn rate is approximately $4-5 million[109]