R&D Pipeline

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

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

Our Programs Represent Large Market Opportunities

 

Sources

  1. Lakshminrusimhaet al. Persistent Pulmonary Hypertension of the Newborn. Neoreviews. 2015;16(12):e680–92.
  2. NCHS, National Hospital Ambulatory Medical Care Survey, 2017. CDC.
  3. 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.
  4. Hall et al. The burden of respiratory syncytial virus infection in young children. N EnglJ Med. 2009;360(6):588–598.
  5. UNICEF
  6. 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
  7. Ringshausenet al. Prevalence of Nontuberculous Mycobacterial Pulmonary Disease, Germany, 2009-2014. EmergInfect Dis. 2016;22(6):1102-1105. doi:10.3201/eid2206.151642
  8. 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.
  9. 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.
  10. Company Presentations and Regulatory Filings from Bristol-Myers Squibb (BMY), Merck (MRK), Roche (RHHBY), AstraZeneca (AZN), Pfizer (PFE), Regeneron (REGN); Sanofi (SNY). 2011-2019.

Important Safety Information

Caution - LungFit is an Investigational Device, Limited by Federal (or United States) Law to Investigational Use.