LUNGFIT BRO

Bronchiolitis

A Leading Cause of Global Child Mortality

Bronchiolitis is an infection of the small airways. It is also the most common manifestation of acute lower respiratory infection (ALRI) in early infancy, and is the leading cause of global child mortality. Viral bronchiolitis is currently the most common reason for pediatric hospital admission in the US, accounting for almost 20% of all-cause infant hospitalizations. Viral etiology is the main cause, and among the respiratory viruses, respiratory syncytial virus (RSV) is believed to be the most important viral pathogen causing ALRI in young children.

Worldwide, it is estimated that 60,000 to 199,000 children younger than 5 years die yearly from RSV-associated ALRI, with 99% of these deaths occurring in developing countries. The disease is common mainly in the first year of life. The clinical signs and symptoms are consistent with hypoxia, difficulty breathing, coryza, poor feeding, cough, wheeze and crepitations on auscultation, and in some cases respiratory failure.

Product Status and Market Potential

Beyond Air Active Pipeline & Market Size

Product	Indication	Development Status	Key Dates*	US Sales Potential**	Worldwide Sales Potential**
LungFitBRO (Bronchiolitis)	Bronchiolitis	Pilot Phase	Pivotal Study expected during 2020/2021 Winter Launch 2022*	>$500m Beyond Air to commercialize	>$1.2b

*All dates are based on projections and appropriate financing, anticipated first launch on global basis pending appropriate regulatory approvals

**All figures are Company estimates for peak year sales: Global Sales Potential includes US Sales Potential

Tremendous Opportunity for Patient Care

There are no drugs approved for the treatment of bronchiolitis¹. The standard of care in the hospital is oxygen and hydration.

Beyond Air’s goal is to reduce the duration of bronchiolitis symptoms in infants and the length of hospitalization. Elderly population trials will follow that of infants.

150M^{2, 3}

new cases of bronchiolitis reported worldwide each year

~130,000⁴

bronchiolitis hospitalizations of children two and under in the U.S. each year

177,000⁵

hospitalizations each year in the U.S. of elderly with equivalent viral infections

>$2B

Beyond Air’s estimate of the global market size with no competitor

Source

American Academy of Pediatrics
Nenna R, Cutrera R, Frassanito A, et al. Modifiable risk factors associated with bronchiolitis. Ther Adv Respir Dis. 2017;11(10):393–401. doi:10.1177/1753465817725722
Mallory MD, Shav DK, Garret J, Bordlev WC. Bronchiolitis management preferences and the influence of pulse oximetry and respiratory rate on the decision to admit. Pediatrics, 2003 Jan;111(1):e45-51.
Hasegawa K, Tsugawa Y, Brown DF, Mansbach JM, Camargo CA, Jr.: Trends in bronchiolitis hospitalizations in the United States, 2000-2009. Pediatrics 2013, 132(1):28-36.
CDC (due to RSV only)

Clinical Development

We have conducted a double-blind, randomized, single-center, 2-arm study. The primary objectives were to study the safety and tolerability of 160 ppm nitric oxide intermittent inhalation treatment in 2- to 12-month old subjects admitted to hospital and diagnosed with acute bronchiolitis. The planned secondary objectives were to assess the efficacy of NO intermittent inhalation treatment (in addition to standard O₂ treatment) compared to standard O₂ treatment alone, assessed as the LOS, clinical score improvement, and length of standard O₂ treatment.