Nitric Oxide Treatment Opportunities

Pipeline

Beyond Air Inc. Product Pipeline
Product/Indication	Preclinical	Pilot Trials	Pivotal	PMA	Commercial	Next Milestone¹
LungFit PH ventilator compatible
Persistent Pulmonary Hypertension of the Newborn (PPHN) worldwide, and cardiac surgery outside US where indicated	Preclinical completed	Pilot Trials completed	Pivotal completed	PMA completed	Commercial started	FDA Approved CE Mark 1H22²
LungFit PRO
Community-Acquired Viral Pneumonia (CAVP), including COVID-19	Preclinical completed	Pilot Trials started	Pivotal not started	PMA not started	Commercial not started	Safety & efficacy CAVP data at ECCMID in April 2022 Initiate US study in 4Q22; pandemic & FDA permitting
Bronchiolitis	Preclinical completed	Pilot Trials started	Pivotal not started	PMA not started	Commercial not started	Initiate US study in 4Q22; pandemic & FDA permitting
LungFit GO
Nontuberculous mycobacteria (NTM) lung infection	Preclinical completed	Pilot Trials started	Pivotal not started	PMA not started	Commercial not started	Safety & efficacy data at ATS in May 2022 (home self-administration)
Severe exacerbations due to lung infections in COPD patients	Preclinical started	Pilot Trials not started	Pivotal not started	PMA not started	Commercial not started	Pilot study start 2022/23
Solid Tumor Program (through Beyond Cancer)
Multiple Solid Tumors	Preclinical started	Pilot Trials not started	Pivotal not started	PMA not started	Commercial not started	First in human trial start in 1H22 AACR in April 2022

Sources

All dates are based on projections and appropriate financing, anticipated first launch on a global basis pending appropriate regulatory approvals
Label expected to include cardiac surgery and PPHN

Sources

Lakshminrusimhaet al. Persistent Pulmonary Hypertension of the Newborn. Neoreviews. 2015;16(12):e680–92.
NCHS, National Hospital Ambulatory Medical Care Survey, 2017. CDC.
Rudanet al. WHO Child Health Epidemiology Reference Group. Global estimate of the incidence of clinical pneumonia among children under five years of age. Bull World Health Organ. 2004 Dec;82(12):895-903.
Hall et al. The burden of respiratory syncytial virus infection in young children. N EnglJ Med. 2009;360(6):588–598.
UNICEF
Winthrop et al. Incidence and prevalence of nontuberculous mycobacterial lung disease in a large U.S. managed care health plan, 2008-2015. Ann Am ThoracSoc, 17 (2020), pp. 178-185
Ringshausenet al. Prevalence of Nontuberculous Mycobacterial Pulmonary Disease, Germany, 2009-2014. EmergInfect Dis. 2016;22(6):1102-1105. doi:10.3201/eid2206.151642
Izumi et al. Epidemiology of Adults and Children Treated for Nontuberculous Mycobacterial Pulmonary Disease in Japan. Ann Am ThoracSoc. 2019 Mar;16(3):341-347. doi: 10.1513/AnnalsATS.201806-366OC. PMID: 30339468.
Jinjuvadia, Chetna et al. Trends in Outcomes, Financial Burden, and Mortality for Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) in the United States from 2002 to 2010. COPD. 2017;14(1):72-79.
Company Presentations and Regulatory Filings from Bristol-Myers Squibb (BMY), Merck (MRK), Roche (RHHBY), AstraZeneca (AZN), Pfizer (PFE), Regeneron (REGN); Sanofi (SNY). 2011-2019.